Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia

Summary

The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper extremity (arm and hands) motor function and manual dexterity. This study will also evaluate the efficacy of TAK-831 versus placebo on activities of daily living (ADL) and other secondary assessments.

Timeline

Start

2017-11-08

Primary completion

2018-12-27

Completion

2018-12-27

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs TAK-831 75 mg; p >0.999; Least Squares Mean Difference -0.00054 (90% CI -0.00179 to 0.00070); ANCOVA NCT03214588 ↗

registry analysis (superiority test); Placebo vs TAK-831 300 mg; p >0.999; Least Squares Mean Difference -0.00069 (90% CI -0.00172 to 0.00033); ANCOVA NCT03214588 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Luvadaxistat	Small molecule	75 mg	Oral
Subject	Luvadaxistat	Small molecule	300 mg	Oral

Indications