drugset / Trial / NCT03440112
Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm
Phase 1/2
Completed
34 enrolled
Nicolaas Bohnen, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedParallel-groupTriple-blindOther
Summary
The arm of this study evaluates possible GABA-A receptor target engagement effects of the FDA-approved medication, transdermal flumazenil (added 4/2020, replaced clarithromycin), in the setting of Parkinson's disease. Half of the subjects will receive transdermal flumazenil for 7-10 days, and half will receive a placebo. \[11C\]Flumazenil GABA-A receptor PET imaging will be used to assess target engagement effects. Note \[11C\]Flumazenil GABA-A receptor PET was not performed as part of the transdermal flumazenil study because of a Covid pandemic research amendment.
Timeline
- Start
- 2018-01-29
- Primary completion
- 2021-12-08
- Completion
- 2021-12-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Flumazenil | Small molecule | 36 mg | Other |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |