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Olesoxime (tro19622)    (DrugBank: TRO19622)

3 diseases
IDDisease name (Link within this page)Number of trials
2Amyotrophic lateral sclerosis1
3Spinal muscular atrophy6
13Multiple sclerosis/Neuromyelitis optica1

2. Amyotrophic lateral sclerosis    [ 508 clinical trials,   530 drugs,   (DrugBank: 146 drugs),   170 drug target genes,   221 drug target pathways]
Searched query = "Amyotrophic lateral sclerosis", "ALS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 508 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2010-021179-10-GB
(EUCTR)		18/04/201131/01/2011An Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzoleAn Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzole Disease under investigation : Amyotrophic lateral Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders		Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: Olesoxime
Other descriptive name: 4 cholesten-3-one, oxime		TROPHOSNULLNot RecruitingFemale: yes
Male: yes		350Germany;United Kingdom;Spain

3. Spinal muscular atrophy    [ 179 clinical trials,   102 drugs,   (DrugBank: 26 drugs),   52 drug target genes,   78 drug target pathways]
Searched query = "Spinal muscular atrophy", "Myelopathic muscular atrophy", "SMA I", "Werdnig-Hoffman disease", "SMA II", "Dubowitz disease", "SMA III", "Kugelberg-Welander disease", "SMA IV"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
6 / 179 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2010-020386-24-GB
(EUCTR)		31/01/201108/10/2010Safety and Efficacy of Olesoxime (TRO19622) in 3-25 yrs SMA patientsPhase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years).
MedDRA version: 14.0;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		TROPHOS SANULLNot Recruiting Female: yes
Male: yes		150Phase 2France;Belgium;Germany;Netherlands;Italy;United Kingdom
2EUCTR2010-020386-24-DE
(EUCTR)		29/12/201028/07/2010Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients.Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years).
MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy		Product Name: OLESOXIME
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime		TROPHOS SANULLNot RecruitingFemale: yes
Male: yes		150Phase 2Belgium;Netherlands;Germany;United Kingdom;Italy
3EUCTR2010-020386-24-NL
(EUCTR)		18/11/201028/06/2010Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients.Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years).
MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy		Product Name: OLESOXIME
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime		TROPHOS SANULLNot RecruitingFemale: yes
Male: yes		150Phase 2Belgium;Germany;Netherlands;United Kingdom;Italy
4NCT01302600
(ClinicalTrials.gov)		November 201018/2/2011Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients.Phase II, Multicenter, Randomized, Adaptive, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Year Old Spinal Muscular Atrophy (SMA) Patients.Spinal Muscular Atrophy Type II;Spinal Muscular Atrophy Type III Non AmbulantDrug: Olesoxime;Drug: PlaceboHoffmann-La RocheAssociation Française contre les Myopathies (AFM), ParisCompleted3 Years25 YearsBoth165Phase 2Belgium;France;Germany;Italy;Netherlands;Poland;United Kingdom
5EUCTR2010-020386-24-BE
(EUCTR)		29/10/201027/07/2010Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients.Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years).
MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy		Product Name: OLESOXIME
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime		TROPHOS SANULLNot RecruitingFemale: yes
Male: yes		150Phase 2Belgium;Germany;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2010-020386-24-FR
(EUCTR)		01/06/2010Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients.Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study to assess safety and efficacy of olesoxime (TRO19622) in 3-25 year old Spinal Muscular Atrophy (SMA) patients. Spinal Muscular Atrophy (type 2 or type 3 non ambulant patients aged 3-25 years)
MedDRA version: 12.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy		Product Name: OLESOXIME
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime		TROPHOS SANULLNAFemale: yes
Male: yes		Phase 2France;Belgium;Germany;Netherlands;United Kingdom;Italy

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13. Multiple sclerosis/Neuromyelitis optica    [ 3,050 clinical trials,   2,147 drugs,   (DrugBank: 348 drugs),   244 drug target genes,   228 drug target pathways]
Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 3,050 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT01808885
(ClinicalTrials.gov)		April 201312/2/2013Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.Relapsing Remitting Multiple SclerosisDrug: olesoxime (TRO19622);Drug: placeboHoffmann-La RocheHôpital de la Timone;SGS S.A.;STRAGEN ServicesCompleted18 YearsN/ABoth44Phase 1France

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