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NCT03462641 · ClinicalTrials.gov registry record · Phase 1
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03462641: Completed Phase 1 study, sponsored by University of Michigan.
NCT03462641 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03462641, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This arm is a positron emission tomography (PET) biomechanistic GABA-A receptor target engagement study that includes detailed clinical and motor assessments before and after the i.v. administration of 1 mg flumazenil or placebo in Parkinson disease subjects. Each subject will receive 1mg flumazenil or placebo at two visits.
Primary Outcome
Postural Instability and Gait Disorder (PIGD) score is a subscale score of MDS-UPDRS scale. It is computed as a sum of following MDS-UPDRS items: 3.10 Gait 3.11 Freezing of gait 3.12 Postural stability 3.13 Posture Minimal possible score is 0, maximal possible score is 16. Higher scores indicate greater severity of PIGD symptoms (worse outcome).
Interventions
- DRUG Placebo
- DRUG Flumazenil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-03-09 |
| Est. Completion | 2021-06-04 |
| Phase | Phase 1 |
What the finished NCT03462641 record still lists
NCT03462641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03462641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03462641 about?
NCT03462641 is a clinical study titled "Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm". This arm is a positron emission tomography (PET) biomechanistic GABA-A receptor target engagement study that includes detailed clinical and motor assessments before and after the i.v. administration of 1 mg flumazenil or placebo in Parkinson disease subjects. Each subject will receive 1mg flumazenil...
What is the current status of trial NCT03462641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-03-09. Estimated completion is 2021-06-04.
What interventions are being tested in trial NCT03462641?
The interventions under investigation include: Placebo (DRUG), Flumazenil (DRUG).
Who is sponsoring clinical trial NCT03462641?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03462641's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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