drugset / Trial / NCT03462641
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
Phase 1/2
Completed
36 enrolled
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedCrossoverTriple-blindOther
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.
Timeline
- Start
- 2018-03-09
- Primary completion
- 2021-06-04
- Completion
- 2021-06-04
Outcome
Met primary endpoint
registry analysis (superiority test); Flumazenil; p = 0.0407; t-value -2.15; Paired-Sample Two-Tailed T-Test NCT03462641 ↗
registry analysis (other test); Placebo Responders; p = 0.00000029; Standardized β Coefficient 0.60 (95% CI 0.13 to 1.07); Mixed Models Analysis NCT03462641 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flumazenil | Small molecule | 1 mg | Intravenous |