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

Status: Completed
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• Male or female aged ≥18 to < 80 years

• Body weight ≥60 kg but ≤100 kg

• Parkinson's disease diagnosed

• Absolute neutrophil count (ANC) ≥1.5 x 10^9/L (≥1.0 x 10^9/L for Black population) at screening

• On a stable dose for at least 3 months prior to the screening visit of any of the following treatments at an L-dopa equivalent daily dose of up to 600 mg:

• Dopaminergic agonist alone

• L-dopa alone

• Combination therapy with dopaminergic agonist and L-dopa

• Rasagiline

• At an early stage of the disease, without motor fluctuations and/or L-dopa-induced dyskinesia

Locations
Other Locations
Canada
Toronto Western Hospital
Toronto
France
CHU de Bordeaux, Centre Expert Parkinson
Bordeaux
Hôpital Henri Mondor
Creteil
Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro
Lille
CHU Dupuytren
Limoges
Hôpital Neurologique Pierre Wertheimer
Lyon
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier
CHU Pontchaillou
Rennes
CHU Charles Nicoll - Rouen
Rouen
Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre
Strasbourg
CHU Purpan, Hôpital Pierre Paul Riquet
Toulouse
Germany
Heinriche-Heine Universität Düsseldorf
Dusseldorf
UKSH Campus Kiel, Neurologie
Kiel
Universitätsklinikum Gießen und Marburg GmbH
Marburg
Klinikum rechts der Isar
Munich
United Kingdom
Fairfield General Hospital
Bury
Royal Devon & Exeter Hospital
Exeter
Charing Cross Hospital
London
Newcastle Clinical Ageing Research Unit
Newcastle Upon Tyne
Derriford Hospital
Plymouth
Time Frame
Start Date: October 12, 2016
Completion Date: September 4, 2019
Participants
Target number of participants: 140
Treatments
Experimental: Deferiprone 300 mg
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
Experimental: Deferiprone 600 mg
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
Experimental: Deferiprone 900 mg
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Experimental: Deferiprone 1200 mg
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Placebo Comparator: Placebo
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day
Sponsors
Leads: ApoPharma

This content was sourced from clinicaltrials.gov

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