Tro19622    (DrugBank: TRO19622)

3 diseases
IDDisease name (Link within this page)Number of trials
2Amyotrophic lateral sclerosis10
3Spinal muscular atrophy8
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.
10 / 508 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-021179-10-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
2EUCTR2010-021179-10-DE
(EUCTR)
15/03/201112/11/2010An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. Amyotrophic Lateral Sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS
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
Spain;Germany;United Kingdom
3EUCTR2010-021179-10-BE
(EUCTR)
28/01/201105/01/2011An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. Amyotrophic Lateral Sclerosis.
MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS
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
Phase 2;Phase 3Spain;Belgium;Germany;United Kingdom
4NCT01285583
(ClinicalTrials.gov)
October 201026/1/2011Safety Extension Study of TRO19622 in ALSAn Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With RiluzoleAmyotrophic Lateral SclerosisDrug: TRO19622Hoffmann-La RocheNULLCompletedN/AN/ABoth271Phase 2;Phase 3Belgium;France;Germany;Spain;United Kingdom
5EUCTR2008-007320-25-ES
(EUCTR)
10/08/200916/07/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol.Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. ESCLEROSIS LATERAL AMIOTRÓFICA.ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles due to destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: TRO19622
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
470Phase 2;Phase 3United Kingdom;Germany;Belgium;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2008-007320-25-GB
(EUCTR)
24/07/200914/04/2009 Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. Disease under investigation : Amyotrophic lateral Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral Sclerosis
TROPHOSNULLNot Recruiting Female: yes
Male: yes
470Phase 2;Phase 3France;Spain;Belgium;Germany;United Kingdom
7EUCTR2008-007320-25-DE
(EUCTR)
24/06/200918/02/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3United Kingdom;Germany;Belgium;France;Spain
8EUCTR2008-007320-25-BE
(EUCTR)
08/06/200928/04/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLNot RecruitingFemale: yes
Male: yes
470Phase 2;Phase 3France;Spain;Belgium;Germany;United Kingdom
9NCT00868166
(ClinicalTrials.gov)
April 30, 200923/3/2009Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALSPhase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With RiluzoleAmyotrophic Lateral SclerosisDrug: Olesoxime;Drug: Placebo Comparator;Drug: RiluzoleHoffmann-La RocheEuropean CommissionCompleted18 Years80 YearsAll512Phase 3Belgium;France;Germany;Spain;United Kingdom;Netherlands
10EUCTR2008-007320-25-FR
(EUCTR)
17/02/200916/03/2009Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzolePhase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease.
MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Code: TRO19622
INN or Proposed INN: olesoxime
Other descriptive name: 4-cholesten-3-one, oxime
TROPHOS SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
470Phase 2;Phase 3United Kingdom;Germany;Belgium;France;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.
8 / 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-IT
(EUCTR)
14/09/201001/09/2010Phase II,multicenter,randomized,adaptive,double-blind,placebo controlled study to assess safety and efficacy of olexosime (TRO19622)in 3-25 year old Spinal Muscular Atrophy (SMA) patientsPhase II,multicenter,randomized,adaptive,double-blind,placebo controlled study to assess safety and efficacy of olexosime (TRO19622)in 3-25 year old Spinal Muscular Atrophy (SMA) patients Spinal Muscular Atrophy - type II or III in non ambulant patients aged 3-25 years
MedDRA version: 9.1;Level: LLT;Classification code 10032950
Product Name: olesoxime
Product Code: TRO19622
INN or Proposed INN: olesoxime
TROPHOSNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Belgium;Germany;Netherlands;United Kingdom;Italy
7EUCTR2006-006845-14-FR
(EUCTR)
20/03/200715/02/2007Open-label Phase 1b, Dose-ranged, Single and Multiple Dose Study to assess Safety and Pharmacokinetics of TRO19622 in 6-25 year old Spinal Muscular Atrophy (SMA) patients.Open-label Phase 1b, Dose-ranged, Single and Multiple Dose Study to assess Safety and Pharmacokinetics of TRO19622 in 6-25 year old Spinal Muscular Atrophy (SMA) patients. Spinal Muscular Atrophy (SMA)
MedDRA version: 9.1;Level: LLT;Classification code 10041582;Term: Spinal muscular atrophy
Product Code: TRO19622
Other descriptive name: 4-cholesten-3-one,oxime
TROPHOSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 1bFrance
8EUCTR2010-020386-24-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

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