Study of Parkinson's Early Stage With Deferiprone

A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 18 - 80 Status: Completed
Time Since Diagnosis: Less than 3 years Study Focus: Cause of PD, Dyskinesia

Study Purpose:

The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with Parkinson's disease. Participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.

More Details

This study will enroll 140 patients who have been diagnosed with Parkinson's disease within the last 3 years and are currently taking antiparkinsonian medication. There are four dosage cohorts, with patients in each cohort receiving either deferiprone tablets or placebo. At the baseline visit, participants will be randomized to a dosage cohort and to either active product or placebo within that cohort, and will take the assigned study product twice-daily for 9 months. They will come back to the study site for assessments at Months 1, 2, 3, 4, 5, 6, and 9, and will need to have their blood count checked weekly, at either the study site or a local laboratory.

Phase: Phase 2 Lead Sponsor: ApoPharma
Trial ID: 004412 Sponsor Type: Industry
Primary Country: Canada Additional Collaborators or Sponsors:
Estimated Enrollment: 140 Study Start Date: July 2016
Estimated Study Completion Date: October 2019 Source:
Study Website:

More Inclusion & Exclusion Criteria

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