Dose-Ranging Study of Delayed-Release Deferiprone in Parkinson
Research type
Research Study
Full title
A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease
IRAS ID
199159
Contact name
Camille Carroll
Contact email
Sponsor organisation
ApoPharma Inc.
Eudract number
2015-004344-19
Clinicaltrials.gov Identifier
126655, IND Number
Duration of Study in the UK
years, 20 months, days
Research summary
This study is looking at a drug called deferiprone for the treatment of Parkinson’s disease. While the exact cause of Parkinson’s disease is unknown, it is possible that its symptoms are due to a build-up of extra iron in certain brain regions. Therefore, getting rid of some of this extra iron might lead to improvement in Parkinson’s symptoms. Deferiprone is an iron chelator, a drug that attaches itself to free molecules of iron in the body and causes them to be flushed out or redistributed. There are several different iron chelators available, but deferiprone is better able than the others to cross the blood-brain barrier and remove iron from the brain. Some small pilot studies that have looked at the effect of deferiprone in Parkinson’s patients have found evidence that it may improve the symptoms of this disease.
This current study is a multi-center, randomized, double-blind, placebo-controlled, dose-ranging study in 140 patients who have been diagnosed with typical Parkinson’s disease up to 3 years prior to the screening visit and are currently taking antiparkinsonian medication. Screening will be conducted within 30 days prior to the start of dosing. At baseline, eligible participants will be randomized to one of four dosage cohorts, and within each cohort will be further randomized in a 4:1 ratio to receive either active product or placebo. The assigned study product will be taken twice-daily (b.i.d.), at least 8 hours apart, for 9 months.
The study will be conducted at treatment centers in North America and Europe.
The study is organized and paid for by the pharmaceutical company ApoPharma Inc.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0067
Date of REC Opinion
31 Mar 2016
REC opinion
Further Information Favourable Opinion