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NCT03214588 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
A Phase 2 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT03214588: Completed Phase 2 study, sponsored by Neurocrine Biosciences.
NCT03214588 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03214588, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an
Interventions
- DRUG TAK-831
- DRUG TAK-831 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2018-12-27 |
| Phase | Phase 2 |
What the finished NCT03214588 record still lists
NCT03214588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which TAK-831 is the first listed.
NCT03214588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03214588 about?
NCT03214588 is a clinical study titled "Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia". 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.
What is the current status of trial NCT03214588?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2017-11-08. Estimated completion is 2018-12-27.
What interventions are being tested in trial NCT03214588?
The interventions under investigation include: TAK-831 (DRUG), TAK-831 Placebo (DRUG).
Who is sponsoring clinical trial NCT03214588?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03214588's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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