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

Parkinson Disease Clinical Trial

Official title: Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson Disease-Flumazenil Arm

Status Completed

Clinical Trial 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.

Clinical Trial Description

This biomechanistic GABA-A receptor target engagement study includes clinical and motor assessments before and at various time points up to approximately 90 minutes after the i.v. administration of 1 mg flumazenil and placebo in Parkinson disease subjects. Thirty Parkinson disease subjects with disease severity (Hoehn and Yahr) stages 2-4 will be recruited. Baseline [11C]FMZ and vesicular monoamine transporter type 2 (VMAT2) [11C]DTBZ brain PET imaging will be performed prior to drug administration to assess for GABA-A receptor availability and the integrity of nigrostriatal dopaminergic nerve terminals, respectively. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03462641
• Study type: Interventional
• Source: University of Michigan
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 9, 2018
• Completion date: June 4, 2021