CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
E2007drug
Likely dose
E2007 up to maximum 8 mg (exact titration schedule not specified in criteria)AI-extracted
Key inclusion· 4
  • ✓Age ≥30 years with idiopathic Parkinson's disease meeting UK Parkinson's Disease Society Brain Bank criteria, Hoehn and Yahr stage 2-4 in 'off' state
  • ✓On stable anti-Parkinsonian treatment for ≥4 weeks without routine "as required" dosing or regular apomorphine/liquid levodopa use
  • ✓Taking levodopa ≥3 times daily with documented good response to each dose
  • ✓Documented end-of-dose wearing-off with ≥2.5 hours "off" time per day and UPDRS Question 39 score ≥1
Key exclusion· 9
  • ✕Previous stereotactic surgery (pallidotomy, subthalamic nucleus DBS) for Parkinson's disease
  • ✕Clinically significant cognitive impairment (MMSE <24 or DSM IV dementia criteria)
  • ✕Active hepatic disease, reduced hepatic function, or liver enzymes >1.5× upper limit of normal (bilirubin or transaminases)
  • ✕QTc prolongation (≥450 msec males, ≥470 msec females by Fridericia correction) or clinically significant ECG abnormality

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

Search/NCT00165789
NCT00165789Phase 2Completed
CompareCT.gov

A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations

Eisai Inc.·interventional·Posted Sep 14, 2005·Updated Jun 2, 2015

In Brief

A Phase 2 clinical trial evaluating E2007 for Parkinson's Disease. Completed, enrolled 75 participants across 10 sites.

Detailed Summary

This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartSep 1, 2005
Primary CompletionFeb 1, 2006
Study CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 20.8 years ago

Interventions

E2007drug