Study of Parkinson's Early Stage With Deferiprone

• Status: Completed
• Trial end date: 2019-09-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ApoPharma
• Treatments: Deferiprone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diagnosis of Parkinson's disease more than 3 years prior to screening visit

• Hoehn and Yahr stage ≥ 3

• Atypical or secondary Parkinsonism without dopa-sensitivity (e.g., vascular parkinsonism, supranuclear palsy, multisystem atrophy)

• Progressing Axis I psychiatric disorders (psychosis, hallucinations, compulsive disorders, substance addiction, bipolar disorder, severe depression, anxiety) as assessed in a semi-structured interview in accordance with the Diagnostic and Statistical Manual of Mental Disorders

• Not stabilized in terms of the current antiparkinsonian therapeutic regimen: already requires dose adaptation and/or is likely to require any change in dopamine therapy over the duration of the trial

• Current treatment with bromocriptine

• Current treatment with any antiparkinsonian drug other than those listed in the inclusion criteria

• Current treatment with coenzyme Q10 or idebenone. (Patients who are on these medications but stop taking them at least 2 weeks prior to baseline may be enrolled.)

• Current use of a Deep Brain Stimulation (DBS) system. (Patients who previously had a DBS system but have had it removed may be enrolled.)