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NCT03041116 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants
A Phase 3 study, sponsored by Travere Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT03041116: Clinical Trial Phase 3 study, sponsored by Travere Therapeutics.
NCT03041116 is a Phase 3 study that was terminated before completion, run by Travere Therapeutics. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03041116, a Phase 3 study, was terminated before completion, sponsored by Travere Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement therapy, was safe and effective in treating participants with PKAN.
Primary Outcome
Change from baseline to Week 24 activities of daily living was assessed on the PKAN-ADL scale based on the Unified Parkinson's Disease Rating Scale (UPDRS) Part II. The PKAN-ADL is a validated measure of the participant's ability to complete ADL that are impacted by the diffuse motor manifestations of PKAN. It consists of 12 items related to activities of daily living, including eating, dressing, and walking. Each item has responses ranging from 0-4, with a higher value indicating greater disabi
Interventions
- DRUG Placebo
- DRUG Fosmetpantotenate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-07-17 |
| Est. Completion | 2019-12-30 |
| Phase | Phase 3 |
Why NCT03041116 stopped before completion
NCT03041116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03041116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03041116 about?
NCT03041116 is a clinical study titled "Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants". This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement therapy, was safe and effective in treating participants with PKAN.
What is the current status of trial NCT03041116?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2017-07-17. Estimated completion is 2019-12-30.
What interventions are being tested in trial NCT03041116?
The interventions under investigation include: Placebo (DRUG), Fosmetpantotenate (DRUG).
Who is sponsoring clinical trial NCT03041116?
This trial is sponsored by Travere Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03041116's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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