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Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease

NCT00909545 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2013-04-17

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Isradipine CR 5mg

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

DRUG

Isradipine CR 10mg

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

DRUG

Isradipine CR 20mg

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

DRUG

Placebo

4 Placebo to Match (PTM) tablets once daily

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Northwestern University Dixon Fund

    collaborator UNKNOWN

  • The Parkinson Study Group

    collaborator NETWORK

  • Northwestern University

    lead OTHER

Principal Investigators

  • Tanya Simuni, MS · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00909545 on ClinicalTrials.gov