CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Clarithromycin (Not used as of 4/2020) +3 moredrug
Likely dose
Clarithromycin (Not used as of 4/2020) 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03440112
NCT03440112Phase 2Completed
CompareCT.gov

Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson

Nicolaas Bohnen, MD, PhD·interventional·Posted Feb 20, 2018·Updated Jan 10, 2023

In Brief

A Phase 2 clinical trial evaluating Clarithromycin (Not used as of 4/2020), Placebo (Not used as of 4/2020), and 2 other interventions for Parkinson Disease. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 20, 2018
Enrollment StartJan 29, 2018
Primary CompletionDec 8, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.4 years ago

Interventions

Clarithromycin (Not used as of 4/2020)drug

Clarithromycin (generic) capsule 250mg each

Placebo (Not used as of 4/2020)drug

Lactose in a gel capsule

Transdermal flumazenil (Added 4/2020)drug

Transdermal flumazenil 24mg/mL

Placebo (Added 4/2020)drug

Transdermal placebo