3. 脊髄性筋萎縮症 Spinal muscular atrophy Clinical trials / Disease details


臨床試験数 : 237 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75

  
6 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001589-25-NL
(EUCTR)
05/04/201607/10/2015A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular AtrophyMulticenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS Spinal Muscular Atrophy
MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Olesoxime
Product Code: RO7090919
INN or Proposed INN: OLESOXIME
INN or Proposed INN: SESAME OIL, REFINED
Other descriptive name: SESAME OIL, REFINED
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
173 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Germany;Netherlands;Italy;United Kingdom
2EUCTR2015-001589-25-FR
(EUCTR)
01/12/201507/12/2015A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular AtrophyMulticenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA Spinal Muscular Atrophy
MedDRA version: 18.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Olesoxime
Product Code: RO7090919
INN or Proposed INN: OLESOXIME
INN or Proposed INN: SESAME OIL, REFINED
Other descriptive name: SESAME OIL, REFINED
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
173Phase 2;Phase 3France;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom
3EUCTR2015-001589-25-BE
(EUCTR)
20/11/201525/09/2015A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular AtrophyMulticenter, open-label, single-arm study to evaluate long term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS Spinal Muscular Atrophy
MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Olesoxime
Product Code: RO7090919
INN or Proposed INN: OLESOXIME
INN or Proposed INN: SESAME OIL, REFINED
Other descriptive name: SESAME OIL, REFINED
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
173Phase 2;Phase 3France;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom
4EUCTR2015-001589-25-GB
(EUCTR)
19/11/201504/08/2015A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular AtrophyMulticenter, open-label, single-arm study to evaluate long term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS Spinal Muscular Atrophy
MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Olesoxime
Product Code: RO7090919
INN or Proposed INN: OLESOXIME
INN or Proposed INN: SESAME OIL, REFINED
Other descriptive name: SESAME OIL, REFINED
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
173Phase 2;Phase 3France;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom
5EUCTR2015-001589-25-IT
(EUCTR)
05/10/201511/08/2015Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA Spinal Muscular Atrophy
MedDRA version: 18.0;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Olesoxime
Product Code: RO7090919
INN or Proposed INN: OLESOXIME
INN or Proposed INN: SESAME OIL, REFINED
Other descriptive name: SESAME OIL, REFINED
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
173Phase 2;Phase 3France;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy
6EUCTR2015-001589-25-PL
(EUCTR)
07/01/2016A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular AtrophyMulticenter, open-label, single-arm study to evaluate long term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS Spinal Muscular Atrophy
MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Olesoxime
Product Code: RO7090919
INN or Proposed INN: OLESOXIME
INN or Proposed INN: SESAME OIL, REFINED
Other descriptive name: SESAME OIL, REFINED
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
173 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Poland;Netherlands;Germany;Italy;United Kingdom