CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
Isradipine CR 5mg +3 moredrug
Likely dose
Isradipine CR 5mgfrom 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/NCT00909545
NCT00909545Phase 2Completed
CompareCT.gov

A Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson Disease

Northwestern University·interventional·Posted May 28, 2009·Updated Apr 17, 2013

In Brief

A Phase 2 clinical trial evaluating Isradipine CR 5mg, Isradipine CR 10mg, and 2 other interventions for Parkinson Disease. Completed, enrolled 99 participants across 20 sites in 2 countries.

Detailed Summary

The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesCanada, United States
CollaboratorsMichael J. Fox Foundation for Parkinson's Research, Northwestern University Dixon Fund, The Parkinson Study Group

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2009
Enrollment StartJul 1, 2009
Primary CompletionDec 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.1 years ago

Interventions

Isradipine CR 5mgdrug

5mg dose: 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily

Isradipine CR 10mgdrug

10mg dose: 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily

Isradipine CR 20mgdrug

20mg dose: 4 Dynacirc CR 5mg tablets once daily

Placebodrug

4 Placebo to Match (PTM) tablets once daily