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 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

  
13 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Status
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agemin
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agemax
Inclusion_
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PhaseCountries
1EUCTR2017-004101-40-HR
(EUCTR)
27/04/201816/05/2019Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;Belarus;Bosnia and Herzegovina;Moldova, Republic of;Bulgaria;Russian Federation;Croatia;Ukraine;Poland;United States
2EUCTR2017-004100-22-HR
(EUCTR)
27/04/201816/05/2019Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
3NCT03319732
(ClinicalTrials.gov)
April 3, 201813/10/2017A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MSAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)Multiple Sclerosis;Spasticity, MuscleDrug: ArbaclofenOsmotica Pharmaceutical US LLCNULLActive, not recruiting18 Years65 YearsAll323Phase 3United States
4EUCTR2017-004101-40-BG
(EUCTR)
23/03/201809/01/2018Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
5EUCTR2017-004101-40-PL
(EUCTR)
21/03/201812/02/2018Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
6EUCTR2017-004100-22-PL
(EUCTR)
21/03/201809/02/2018Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
7EUCTR2017-004100-22-BG
(EUCTR)
16/03/201808/01/2018Arbaclofen Extended-Release Tablets for Treatment of Spasticity in Patients with Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Multiple Sclerosis (Study OS440-3004) Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
8NCT03290131
(ClinicalTrials.gov)
January 28, 201819/9/2017A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MSA Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple SclerosisMultiple Sclerosis;Spasticity, MuscleDrug: Arbaclofen;Drug: PlaceboOsmotica Pharmaceutical US LLCNULLCompleted18 Years65 YearsAll536Phase 3Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Moldova, Republic of;Poland;Serbia;United States
9NCT02869425
(ClinicalTrials.gov)
July 20163/8/2016To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MSA Randomized, Double-Blind, Parallel-Group Study to Assess the Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With Multiple SclerosisMultiple Sclerosis;SpermDrug: arbaclofen ER Tablets;Drug: Placebo for arbaclofen ER tabletsOsmotica Pharmaceutical US LLCNULLWithdrawn18 Years55 YearsMale0Phase 3United States
10NCT01844232
(ClinicalTrials.gov)
April 201324/4/2013One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With SpasticityA One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With SpasticityMultiple Sclerosis;SpasticityDrug: arbaclofenOsmotica Pharmaceutical US LLCNULLCompleted18 Years70 YearsAll150Phase 3United States;Russian Federation;Ukraine
11NCT01743651
(ClinicalTrials.gov)
November 201228/11/2012Efficacy Study of Arbaclofen to Treat Spasticity in Multiple SclerosisA Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple SclerosisSpasticity;Multiple SclerosisDrug: arbaclofen;Drug: baclofen;Drug: PlaceboOsmotica Pharmaceutical US LLCNULLCompleted18 Years65 YearsAll353Phase 3United States;Russian Federation;Ukraine
12NCT01360489
(ClinicalTrials.gov)
September 201123/5/2011Arbaclofen Placarbil for the Treatment of Spasticity in Subjects With Multiple Sclerosis (MS)An Open Label, 26-Week Study Assessing Arbaclofen Placarbil Safety and Efficacy in Subjects With Spasticity Associated With Multiple Sclerosis With an Addendum Open-Label, 36-Week Study Assessing Arbaclofen Placarbil Safety in Subjects With Spasticity Associated With Multiple SclerosisMultiple SclerosisDrug: arbaclofen placarbilXenoPort, Inc.NULLCompleted18 Years70 YearsBoth218Phase 3United States
13NCT01359566
(ClinicalTrials.gov)
May 201122/5/2011Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple SclerosisA Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple SclerosisMultiple SclerosisDrug: Arbaclofen placarbil 15 mg BID;Drug: Placebo;Drug: Arbaclofen placarbil 30 mg BID;Drug: Arbaclofen placarbil 45 mg BIDXenoPort, Inc.NULLCompleted18 Years70 YearsAll228Phase 3United States