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Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm

NCT03440112 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-01-10

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Clarithromycin (Not used as of 4/2020)

Clarithromycin (generic) capsule 250mg each

DRUG

Placebo (Not used as of 4/2020)

Lactose in a gel capsule

DRUG

Transdermal flumazenil (Added 4/2020)

Transdermal flumazenil 24mg/mL

DRUG

Placebo (Added 4/2020)

Transdermal placebo

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Nicolaas Bohnen, MD, PhD

    lead OTHER

Principal Investigators

  • Nicolaas I Bohnen, MD, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2021-12-08
Completion
2021-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440112 on ClinicalTrials.gov