Study of Parkinson's Early Stage With Deferiprone (SKY)
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Deferiprone
Eligibility 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.)
Sites / Locations
- Toronto Western Hospital
- CHU de Bordeaux, Centre Expert Parkinson
- Hôpital Henri Mondor
- Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro
- CHU Dupuytren
- Hôpital Neurologique Pierre Wertheimer
- CHRU de Montpellier - Hôpital Gui de Chauliac
- CHU Pontchaillou
- CHU Charles Nicoll - Rouen
- Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre
- CHU Purpan, Hôpital Pierre Paul Riquet
- Heinriche-Heine Universität Düsseldorf
- UKSH Campus Kiel, Neurologie
- Universitätsklinikum Gießen und Marburg GmbH
- Klinikum rechts der Isar
- Royal Devon & Exeter Hospital
- Fairfield General Hospital
- Charing Cross Hospital
- Newcastle Clinical Ageing Research Unit
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Deferiprone 300 mg
Deferiprone 600 mg
Deferiprone 900 mg
Deferiprone 1200 mg
Placebo
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg
One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg
One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg
Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg
Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day