Fig ( DrugBank: Fig )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2

2. 筋萎縮性側索硬化症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04788745
(ClinicalTrials.gov)
June 29, 20212/3/2021Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)Targeting Metabolic Flexibility in ALS (MetFlex); Safety and Tolerability of Trimetazidine for the Treatment of ALSAmyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: Trimetazidine DihydrochlorideThe University of QueenslandFightMND;UMC Utrecht;King's College London;Julius Clinical, The NetherlandsRecruiting18 Years75 YearsAll36Phase 2Australia;Netherlands;United Kingdom
2JPRN-UMIN000008527
2009/01/0125/07/2012Study of efficacy and safety of NDDPX08 in ALS patientsStudy of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research Amyotrophic Lateral SclerosisFor 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.
FeGALSNULLComplete: follow-up complete20years-old75years-oldMale and Female50Not selectedJapan