NCT02728843

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Deferiprone	600 mg tablets
DRUG	Placebo	Tablets that match the deferiprone tablets in appearance

Timeline

• Start date: 2016-10-12
• Primary completion: 2019-08-02
• Completion: 2019-09-04
• First posted: 2016-04-05
• Last updated: 2024-04-10
• Results posted: 2024-04-10

Locations

20 sites across 4 countries: Canada, France, Germany, United Kingdom