2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| 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 | EUCTR2020-004590-51-IT (EUCTR) | 24/01/2022 | 07/06/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB067 (ISIS666853)] INN or Proposed INN: tofersen Other descriptive name: BIIB067 | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2016-003225-41-IT (EUCTR) | 10/02/2020 | 15/06/2021 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - na | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB067 (ISIS666853)] | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 182 | Phase 3 | United States;European Union;Canada;Spain;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Japan;Italy | ||
| 3 | EUCTR2010-022808-40-IT (EUCTR) | 13/01/2011 | 02/02/2011 | A fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - ND | A fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - ND | amyotrophic lateral sclerosis MedDRA version: 9.1;Level: PT;Classification code 10002026 | Trade Name: sativex INN or Proposed INN: sativex | FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 4 | EUCTR2009-016066-91-IT (EUCTR) | 10/03/2010 | 17/11/2009 | SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - ND | SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - ND | ALS MedDRA version: 9.1;Level: SOC;Classification code 10029205 | Trade Name: EPREX*1SIR 40000UI/ML 1ML INN or Proposed INN: Erythropoietin | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 5 | EUCTR2009-010060-41-IT (EUCTR) | 24/02/2009 | 06/03/2009 | Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND | Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND | Amyotrophic Lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: LITIO CARBONATO INN or Proposed INN: Lithium Trade Name: RILUTEK INN or Proposed INN: Riluzole | AZIENDA OSPEDALIERA PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 6 | JPRN-UMIN000008527 | 2009/01/01 | 25/07/2012 | Study of efficacy and safety of NDDPX08 in ALS patients | Study of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research | Amyotrophic Lateral Sclerosis | For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level. The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment. Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study. | FeGALS | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 50 | Not selected | Japan |
| 7 | EUCTR2008-001094-15-IT (EUCTR) | 10/03/2008 | 10/03/2008 | SINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OFAMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | SINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OFAMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | ALS patient according with the El-Escorial criteria MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: CARBOLITHIUM*100CPS 150MG INN or Proposed INN: Lithium | AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 8 | EUCTR2007-004165-17-IT (EUCTR) | 25/09/2007 | 15/10/2007 | Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND | Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND | Amyotrophic lateral sclerosis (ALS) MedDRA version: 6.1;Level: PT;Classification code 10002026 | INN or Proposed INN: Ceftriaxone | AZIENDA OSPEDALIERA PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 9 | EUCTR2006-002660-26-IT (EUCTR) | 01/02/2007 | 10/11/2006 | A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND | A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506 | ONO PHARMA UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 10 | EUCTR2005-005873-31-IT (EUCTR) | 01/08/2005 | 14/03/2006 | A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - ND | A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - ND | Amiotrophic Lateral Sclerosis MedDRA version: 6.1;Level: PT;Classification code 10002026 | Trade Name: EPREX IV SC 1FL 1ML 40000 UI INN or Proposed INN: Erythropoietin | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Italy | |||
| 11 | EUCTR2004-004158-23-IT (EUCTR) | 15/04/2005 | 09/08/2007 | DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | Amyotrophic lateral sclerosis therapy MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: ZIBREN*20BUST 500MG INN or Proposed INN: Acetylcarnitine | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | Italy |