Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=478
{ "count": 4874, "next": "http://api.gregory-ms.com/trials/?format=api&page=479", "previous": "http://api.gregory-ms.com/trials/?format=api&page=477", "results": [ { "trial_id": 114, "title": "Clinical Isolation Syndrome of Spinal Cord and Multiple Sclerosis", "summary": "Conditions: Clinical Isolation Syndrome of Spinal Cord; Multiple SclerosisIntervention: Sponsor : Peking University Third HospitalRecruiting ", "published_date": "2021-07-07T16:00:00Z", "discovery_date": "2021-07-07T11:59:36Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04952246?cond=Multiple+Sclerosis&amp;sfpd_d=14&amp;sel_rss=new14", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT04952246" }, "categories": [], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 109, "title": "Regular Exercise Improves Physical Capacity and Promotes Neurotrophins in Patients With Multiple Sclerosis", "summary": "Conditions: Multiple Sclerosis; Exercise Intervention; Neuro-Degenerative DiseaseIntervention: Behavioral: Regular ExerciseSponsor : Ege UniversityCompleted ", "published_date": "2021-05-20T00:00:00Z", "discovery_date": "2021-06-29T16:46:42Z", "link": "https://clinicaltrials.gov/show/NCT04944251", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04944251" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "11120493", "last_refreshed_on": "2021-07-05", "scientific_title": "Exercise in Persons With Multiple Sclerosis", "primary_sponsor": "Ege University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2019-04-01", "target_size": "43", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).", "phase": "N/A", "countries": "Turkey", "contact_firstname": "; ;", "contact_lastname": "Mehmet ACIK, Dr;Seckin Senisik, Ass. Prof.;Nur Yuceyar, Professor", "contact_address": null, "contact_email": ";;", "contact_tel": ";;", "contact_affiliation": "Ege University;Ege University;Ege University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - A total of 53 relapsing remitting form MS (RRMS) patients between the ages of 18-55\r<br> years, diagnosed with definite MS according to 2017 McDonald criteria, and followed up\r<br> in Ege University MS and Demyelinating Diseases Unit, without an MS attack in the last\r<br> 3 months, had an EDSS score = 4 that did not change with symptomatic or\r<br> immunomodulatory treatments within 6 months were included in this prospective\r<br> randomized controlled study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients who did not meet the inclusion criteria were excluded from the study.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Exercise Intervention;Neuro-Degenerative Disease", "intervention": "Behavioral: Regular Exercise", "primary_outcome": "Aerobic capacity assessment after exercise intervention;Strength assessment after exercise intervention;plasma neurotrophin values (pg/ml)", "secondary_outcome": null, "secondary_id": "19-4T/43", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 112, "title": "CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Behavioral: eSupport Health Weekly Group Sessions for PwMSSponsor : eSupport HealthNot yet recruiting ", "published_date": "2021-06-29T16:00:00Z", "discovery_date": "2021-06-29T16:46:42Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04943887?cond=Multiple+Sclerosis&amp;sfpd_d=14&amp;sel_rss=new14", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT04943887" }, "categories": [], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 111, "title": "Impact of Direct Current Electrical Stimulation on Spasticity Levels and Functional Muscle Use in MS", "summary": "Condition: Multiple SclerosisIntervention: Device: NeuBieSponsors : Centura Health; NeuFit - Neurological Fitness and EducationNot yet recruiting ", "published_date": "2021-06-29T16:00:00Z", "discovery_date": "2021-06-29T16:46:42Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04942938?cond=Multiple+Sclerosis&amp;sfpd_d=14&amp;sel_rss=new14", "source": "Clinical Trials.gov", "relevant": null, "identifiers": { "nct": "NCT04942938" }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "article_count": 180 } ], "export_date": null, "internal_number": null, "last_refreshed_on": null, "scientific_title": null, "primary_sponsor": null, "retrospective_flag": null, "date_registration": null, "source_register": null, "recruitment_status": null, "other_records": null, "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": null, "date_enrollement": null, "target_size": null, "study_type": null, "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": null, "exclusion_criteria": null, "condition": null, "intervention": null, "primary_outcome": null, "secondary_outcome": null, "secondary_id": null, "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 110, "title": "Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple Sclerosis", "summary": "Condition: Primary Progressive Multiple SclerosisIntervention: Biological: DUOC-01Sponsor : Joanne Kurtzberg, MDNot yet recruiting ", "published_date": "2021-06-21T00:00:00Z", "discovery_date": "2021-06-29T16:46:42Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04943289", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04943289" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13675820", "last_refreshed_on": "2024-02-05", "scientific_title": "Phase IA Trial of Intrathecal Administration of Human Umbilical Cord Blood-Derived Cell Therapy (DUOC-01) in Adults With Primary Progressive Multiple Sclerosis (PPMS)", "primary_sponsor": "Joanne Kurtzberg, MD", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2021-01-24", "target_size": "20", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 1", "countries": "United States", "contact_firstname": "; ;", "contact_lastname": "Beth Shaz, MD;Erin Arbuckle;Erin Arbuckle", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";919-684-3293;", "contact_affiliation": "Duke University;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Male and female subjects must be 18-65 years of age\r<br>\r<br> 2. Diagnosis of primary progressive MS according to 2017 revised McDonald criteria (26)\r<br>\r<br> 3. EDSS score at screening 3.0-6.5 that was not acquired within the last 6 months\r<br>\r<br> 4. Stable disease state as evidenced by no significant change in EDSS (1 point or more)\r<br> in the last 3 months\r<br>\r<br> 5. Patients must have a suitably matched, banked UCB per section 5.3\r<br>\r<br> 6. Able to complete a written informed consent prior to any study assessments\r<br>\r<br> 7. Patients of childbearing potential must practice effective contraception during the\r<br> study, and be willing to continue contraception for at least 6 months after DUOC-01\r<br> dosing so that, in the opinion of the Investigator, they will not become pregnant\r<br> during the course of the study.\r<br>\r<br> 8. Patient is a good candidate for the trial, in the opinion of the Investigators\r<br>\r<br> 9. Subjects on disease-modifying therapies upon entering the study must continue on these\r<br> therapies as a concomitant treatment throughout the course of the study to minimize\r<br> additional variables. However, changes in these disease-modifying therapies can occur\r<br> at the clinician's discretion, if there are clinical reasons to do so, which would be\r<br> documented.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - 1. Prior organ, tissue, or stem cell transplant or cell therapy within 3 years of\r<br> study entry 2. Diagnosis of a progressive neurological disorder other than MS 3.\r<br> Active, chronic disease of the immune system other than MS 4. Any medical condition\r<br> that the investigator deems as unsuitable with therapy 5. Inability to have an MRI\r<br> brain scan, or lumbar puncture (i.e., claustrophobia, allergy to contrast, bleeding\r<br> disorder, or on anticoagulation) 6. Intractable seizures 7. Chronic aspiration 8.\r<br> Bleeding disorder 9. Evidence of HIV infection or HIV positive serology 10.\r<br> Uncontrolled bacterial, viral, or fungal infection within 2 weeks of DUOC-01\r<br> administration, as defined by progression while on appropriate treatment 11. History\r<br> of malignancy of any organ system within the past two years with the exception of\r<br> basal cell carcinoma or squamous cell carcinoma of the skin that has been excised with\r<br> clear margins. 12. Requirement of ventilatory support 13. Pregnant or breastfeeding or\r<br> intention to become pregnant during the study 14. Active concurrent malignancy, or\r<br> receiving concurrent radiotherapy, immunosuppressive medications for conditions other\r<br> than MS, or cytotoxic chemotherapy 15. Patients with Suicidal Ideation in the past 6\r<br> months per screening on C-SSRS; patients with Suicidal Behavior in the past 2 years,\r<br> except for Non-suicidal self-injurious behavior 16. Abnormal lab values:\r<br>\r<br> - Total bilirubin>2.0 mg/dl unless due to Gilbert's syndrome\r<br>\r<br> - AST or ALT > 5 times the ULN\r<br>\r<br> - WBC <2.0x 103/µL\r<br>\r<br> - ALC <0.5 x 103/ µL\r<br>\r<br> - Serum creatinine >2x ULN\r<br>\r<br> - eGFR <60 mg/mmol\r<br>\r<br> - CD4 count <200 cells/mm3\r<br>", "exclusion_criteria": null, "condition": "Primary Progressive Multiple Sclerosis", "intervention": "Biological: DUOC-01", "primary_outcome": "Incidence of IT administration adverse events;Incidence of adverse events attributed to the investigational product", "secondary_outcome": null, "secondary_id": "Pro00107012", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 108, "title": "PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers", "summary": "Condition: Multiple SclerosisIntervention: Drug: PIPE-307Sponsor : Pipeline Therapeutics, Inc.Not yet recruiting ", "published_date": "2021-06-18T00:00:00Z", "discovery_date": "2021-06-28T16:23:24Z", "link": "https://clinicaltrials.gov/show/NCT04941781", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04941781" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "12584644", "last_refreshed_on": "2022-10-17", "scientific_title": "A Phase 1, Open-label Study of PIPE-307 to Determine Muscarinic Type I Receptor (M1AChR) Occupancy Parameters by [11C] PIPE-307 PET Imaging in Healthy Volunteers", "primary_sponsor": "Pipeline Therapeutics, Inc.", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "25 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2021-09-01", "target_size": "6", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 1", "countries": "United Kingdom", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Key Criteria:\r<br>\r<br> - Normotensive male or female volunteers between 25-65 years old\r<br>\r<br> - Deemed healthy on the basis of a clinical history, physical examination, ECG, vital\r<br> signs, and laboratory tests of blood and urine\r<br>\r<br> Key Exclusion Criteria:\r<br>\r<br> - Clinically relevant abnormal findings at the screening assessments\r<br>\r<br> - Clinically relevant abnormal medical history or concurrent medical condition\r<br>\r<br> - Acute or chronic illness\r<br>\r<br> - Contraindications to MRI, CT, PET, or arterial cannulation procedures\r<br>\r<br> - Significant exposure to research related radiation or other exposure (defined as ICRP\r<br> category IIb or no more than 10 mSv)\r<br>\r<br> - Positive tests for hepatitis B surface antigen (HBsAg) & Hepatitis C virus (HCV)\r<br> antibody, human immunodeficiency virus (HIV) antibody\r<br>\r<br> - Drug or alcohol abuse\r<br>\r<br> - Smoke more than 10 cigarettes daily\r<br>\r<br> - Loss of more than 400 mL blood\r<br>\r<br> - Vital signs or ECGs outside the acceptable range\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: PIPE-307", "primary_outcome": "M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours", "secondary_outcome": null, "secondary_id": "PTI-307-102", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 106, "title": "Reading Problems Associated With Central Nervous System (CNS) Pathologies.", "summary": "Conditions: Injury Brain; Eye Abnormalities; Multiple Sclerosis; Parkinson Disease; Ataxia, CerebellarIntervention: Diagnostic Test: eye trackingSponsors : Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA; Hospital Clínico Universitario de Valladolid; Hospital del Río HortegaEnrolling by invitation ", "published_date": "2021-06-16T00:00:00Z", "discovery_date": "2021-06-24T16:09:29Z", "link": "https://clinicaltrials.gov/show/NCT04937725", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04937725" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "12823111", "last_refreshed_on": "2023-02-13", "scientific_title": "Reading Problems Associated With Central Nervous System Pathologies", "primary_sponsor": "Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "80 Years", "inclusion_gender": "All", "date_enrollement": "2021-06-01", "target_size": "75", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Spain", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients and normal volunteers with ages between 18 and 80 years old.\r<br>\r<br> - Clinical radiological neurological stability in acute CNS diseases (= 3 months after\r<br> ACD).\r<br>\r<br> - Best distant binocular visual acuity, equal or greater than 0.5 (Decimal Scale). Best\r<br> close binocular visual acuity, equal or greater than 20/40.Glasses or soft contact\r<br> lenses users.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Presence of visual heminegligence evaluated with clock drawing test and line bisection\r<br> test.\r<br>\r<br> - Presence of visual agnosia: Poppelreuter-Ghent © test.\r<br>\r<br> - Presence of cognitive deficit: mini mental state examination (MMSE), with sufficient\r<br> residual hearing capacity.\r<br>\r<br> - Medical history, or presence after ophthalmic examination of: maculopathy, advanced\r<br> cataracts, ophthalmological diseases affecting central visual acuity or macular\r<br> fixation.\r<br>\r<br> - Healthy control subjects should have normal monocular perimetry using standard Swedish\r<br> interactive threshold algorithm (SITA) Central 30-2 Humphrey® Perimeter Test .\r<br>", "exclusion_criteria": null, "condition": "Injury Brain;Eye Abnormalities;Multiple Sclerosis;Parkinson Disease;Ataxia, Cerebellar", "intervention": "Diagnostic Test: eye tracking", "primary_outcome": "Reading performance", "secondary_outcome": "Reading performance", "secondary_id": "PI21-2247 TFM", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 105, "title": "The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients", "summary": "Condition: Multiple SclerosisIntervention: Other: Self-AcupressureSponsor : Istanbul Sabahattin Zaim UniversityNot yet recruiting ", "published_date": "2021-06-15T00:00:00Z", "discovery_date": "2021-06-23T16:33:29Z", "link": "https://clinicaltrials.gov/show/NCT04936555", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04936555" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "11189767", "last_refreshed_on": "2021-07-26", "scientific_title": "The Effect of Self-Acupressure Application on Functional Composite and Quality of Life in Multiple Sclerosis Patients", "primary_sponsor": "Istanbul Sabahattin Zaim University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2021-05-01", "target_size": "60", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant).", "phase": "N/A", "countries": "Turkey", "contact_firstname": "", "contact_lastname": "Zülfünaz ÖZER, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Istanbul Sabahattin Zaim University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - To be able to communicate adequately\r<br>\r<br> - Not having psychiatric problems\r<br>\r<br> - Volunteering to participate in research\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - None\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Self-Acupressure", "primary_outcome": "Multiple Sclerosis Functional Composite (MSFC);Multiple Sclerosis Functional Composite (MSFC);Multiple Sclerosis Quality of Life Scale-54;Multiple Sclerosis Quality of Life Scale-54", "secondary_outcome": null, "secondary_id": "26915", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 104, "title": "Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)", "summary": "Condition: Multiple SclerosisIntervention: Drug: CladribineSponsors : Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany; Merck Hellas sa., GreeceRecruiting ", "published_date": "2021-06-17T00:00:00Z", "discovery_date": "2021-06-22T14:45:49Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04934800", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04934800" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "13694781", "last_refreshed_on": "2024-02-19", "scientific_title": "Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)", "primary_sponsor": "Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2019-12-10", "target_size": "260", "study_type": "Observational", "study_design": null, "phase": null, "countries": "Greece;Italy;Norway;Poland;Portugal;Switzerland;Greece;Italy;Norway;Poland;Portugal;Switzerland;Austria", "contact_firstname": "", "contact_lastname": "Medical Responsible", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Participants with confirmed diagnosis of RRMS diagnosed by the treating physician\r<br> according to applicable clinical practice guidelines -(currently McDonald 2017\r<br> criteria), with high disease activity\r<br>\r<br> - Participants should have been treated with the same first-line DMD (Interferons,\r<br> Glatiramer Acetate, Teriflunomide, DMF) and at a stable dose for at least one year\r<br> prior to switch to Cladribine tablets and should have been prescribed Cladribine\r<br> tablets, according to the decision of the treating physician, prior to enrollment in\r<br> the study. Any washout period and/or washout methods required before switching (such\r<br> as elimination of Teriflunomide) must have been conducted, according to the decision\r<br> of the treating physician\r<br>\r<br> - Required history data should be available: Multiple Sclerosis (MS) data for the\r<br> 12-months pre-baseline period (annualized relapse rate); MS Medication History (prior\r<br> DMDs)\r<br>\r<br> - Fulfilment of the criteria for treatment with Cladribine tablets per standard of care\r<br> in accordance with the local Summary of Product Characteristics (SmPC)\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Contraindications to use of cladribine tablets according to the SmPC\r<br>\r<br> - Participants with history of alcohol or drug abuse that could potentially interfere\r<br> with their participation in the study\r<br>\r<br> - Participants that have received Cladribine in the past\r<br>\r<br> - Concurrent participation in an investigational study in which participant assessment\r<br> and/or treatment may be dictated by a protocol\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Cladribine", "primary_outcome": "Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period Before the End of Study Follow-Up", "secondary_outcome": "Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period After the Start of Cladribine;Percentage of Participants with 6-Month Disability Progression in Expanded Disability Status Scale (EDSS);Percentage of Participants with 6-Month Disability Progression in Timed 25 Foot Walk (T25FW);Percentage of Participants with 6-Month Disability Progression in 9-Hole-Peg Test (9HPT);Percentage of Participants with 6-Month Disability Improvement in Expanded Disability Status Scale (EDSS);Percentage of Participants with 6-Month Disability Improvement in Timed 25 Foot Walk (T25FW);Percentage of Participants with 6-Month Disability Improvement in 9-Hole-Peg Test (9HPT);Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Quality of Life Assessed by Multiple Sclerosis Impact Scale (MSIS-29);Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale;Pharmacoeconomic Data Assessed by Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Questionnaire;Percentage of Participants With Treatment Adherence", "secondary_id": "MS700568_0070", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 103, "title": "Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Sponsors : Uğur OVACIK; Istanbul University-CerrahpasaNot yet recruiting ", "published_date": "2021-06-14T00:00:00Z", "discovery_date": "2021-06-21T20:04:49Z", "link": "https://clinicaltrials.gov/show/NCT04933110", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04933110" }, "categories": [], "export_date": "2024-05-17T00:00:00Z", "internal_number": "11120017", "last_refreshed_on": "2021-07-05", "scientific_title": "Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis in the Very Early Stage.", "primary_sponsor": "Ugur OVACIK", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2021-07-05", "target_size": "90", "study_type": "Observational", "study_design": null, "phase": null, "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - MS diagnosis according to McDonald criteria\r<br>\r<br> - Relapsing Remitting MS clinical course type\r<br>\r<br> - 18-65 age range\r<br>\r<br> - Being able to understand and read Turkish\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Having an MS attack in the last 3 months\r<br>\r<br> - To have done regular exercise for the upper extremity in the 6 months before starting\r<br> the study\r<br>\r<br> - Having different neurological, orthopedic or cardiac problems other than MS\r<br>\r<br> - Being addicted to alcohol or drugs\r<br>\r<br> - Getting a score below 24 on the Mini Mental Test Scale\r<br>\r<br> - Having a spasticity of 3 or more according to the Modified Ashworth Scale\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": null, "primary_outcome": "Nine Hole Peg Test;Minnesota Manual Dexterity Test;ABILHAND;Motor Activity Log-28;Community Integration Questionnaire", "secondary_outcome": "Hand Held Dynamometer;Hand Dynamometer;Pinchmeter;Tuning fork;Aesthesiometer;Fatigue Severity Scale;Symbol Digit Modalities Test;Hospital Anxiety and Depression Scale", "secondary_id": "IAÜ2", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null } ] }