2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 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 | NCT04788745 (ClinicalTrials.gov) | June 29, 2021 | 2/3/2021 | Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS) | Targeting Metabolic Flexibility in ALS (MetFlex); Safety and Tolerability of Trimetazidine for the Treatment of ALS | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: Trimetazidine Dihydrochloride | The University of Queensland | FightMND;UMC Utrecht;King's College London;Julius Clinical, The Netherlands | Recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | Australia;Netherlands;United Kingdom |
| 2 | JPRN-UMIN000008527 | 2009/01/01 | 25/07/2012 | Study of efficacy and safety of NDDPX08 in ALS patients | 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 |