At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
TAK-831 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adult Subjects With Friedreich Ataxia
In Brief
A Phase 2 clinical trial evaluating TAK-831 and TAK-831 Placebo for Friedreich Ataxia. Completed, enrolled 67 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFriedreich Ataxia
CountriesUnited States
CollaboratorsTakeda
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartNov 2017
Primary CompletionDec 2018
TodayJul 2026
First PostedJul 11, 2017
Enrollment StartNov 8, 2017
Primary CompletionDec 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.0 years ago
Interventions
TAK-831drug
TAK-831 tablets
TAK-831 Placebodrug
TAK-831 placebo matching tablets