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

NCT03462641 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-09-27

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Flumazenil

1mg in 10cc normal saline

DRUG

Placebo

10 cc normal saline

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2021-06-04
Completion
2021-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03462641 on ClinicalTrials.gov