Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT

Phase 2

Terminated

• Conditions: Parkinson's Disease
• Interventions: Drug: placebo; Drug: perampanel

• Registration Number: NCT00566462
• Lead Sponsor: Eisai Inc.

Brief Summary

This is a two-arm, double-blind, placebo-controlled study.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-03
• Primary Completion: 2008-12-01
• Study Completion: 2008-12-01
• Results First Submitted: 2012-11-20
• Results First Submitted QC: 2012-11-20
• Results First Posted: 2012-12-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
perampanel	perampanel	-

Primary Outcome Measures

Name	Time	Method
Change in Striatal [^123I]-Iodobenzamine (IBZM_ Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4	Baseline and Week 4

Secondary Outcome Measures

Name	Time	Method
Change in Caudate and Putamen [^123I]-IBZM Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4	Baseline and Week 4

Trial Locations

Locations (3)

inVentiv; 🇺🇸 The Woodlands, Texas, United States

Kenneth Marek; 🇺🇸 New Haven, Connecticut, United States

Molecular NeuroImaging, LLC; 🇺🇸 New Haven, Connecticut, United States