13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-004868-95-ES (EUCTR) | 26/05/2022 | 22/12/2021 | AMANTADINE AND TRANSCRANIAL MAGNETIC STIMULATION FOR TREATING FATIGUE IN MULTIPLE SCLEROSIS | AMANTADINE AND TRANSCRANIAL MAGNETIC STIMULATION FOR TREATING FATIGUE IN MULTIPLE SCLEROSIS: PHASE III STUDY, CONTROLLED, RANDOMIZED, CROSSED OVER AND DOUBLE BLIND - FETEM | Fatigue in multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Amantadine Level Product Name: Amantadine INN or Proposed INN: INN Other descriptive name: AMANTADINE HYDROCHLORIDE | Fundación para la Inv. Biomédica Hospital Clínico San Carlos | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 4 | Spain | ||
| 2 | NCT03567057 (ClinicalTrials.gov) | July 18, 2018 | 22/5/2018 | A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Multiple Sclerosis;Walking Impairment | Drug: ADS-5102, 274 mg | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 424 | Phase 3 | United States;Canada |
| 3 | NCT03436199 (ClinicalTrials.gov) | March 29, 2018 | 12/2/2018 | Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment | A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102, 137 mg;Drug: ADS-5102, 274 mg;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 558 | Phase 3 | United States;Canada |
| 4 | NCT03185065 (ClinicalTrials.gov) | October 4, 2017 | 9/6/2017 | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis | Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis | Fatigue in Multiple Sclerosis | Drug: Amantadine;Drug: Modafinil;Drug: Methylphenidate;Drug: Placebos | Johns Hopkins University | Patient-Centered Outcomes Research Institute | Completed | 18 Years | N/A | All | 141 | Phase 3 | United States |
| 5 | NCT02471222 (ClinicalTrials.gov) | May 2015 | 11/6/2015 | Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 60 | Phase 2 | United States |
| 6 | EUCTR2012-003418-15-AT (EUCTR) | 23/10/2012 | 09/11/2012 | Methylphenidate modified release as treatment of MS-associated fatigue. | Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. | Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ritalin LA 20mg capsules Product Name: Methylphenidate modified release 20 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 30mg capsules Product Name: Methylphenidate modified release 30 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 40mg capsules Product Name: Methylphenidate modified release 40 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE | Medizinische Universität Wien | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Austria | ||
| 7 | EUCTR2010-023678-38-IT (EUCTR) | 20/04/2011 | 02/02/2011 | High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND | High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND | patients with multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10028245 | Trade Name: MANTADAN*20CPR 100MG INN or Proposed INN: Amantadine Trade Name: AMPYRA INN or Proposed INN: Ampyra | FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR | NULL | Not Recruiting | Female: yes Male: yes | Italy |