Deferiprone for the Treatment of Parkinson’s Disease

Phase 2

Completed

• Conditions: Early-stage Parkinson’s disease; Neurological - Parkinson's disease

• Registration Number: ACTRN12617001578392
• Lead Sponsor: ApoPharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-24
• Study Completion: 2019-10-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Main inclusion criteria (all patients):

1. Male or female aged 18 to < 80 years
2. Parkinson’s disease diagnosed according to UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria and based on the presence of at least two of the three cardinal features of the disease (rest tremor, bradykinesia, and rigidity). If rest tremor is not present, patients must have unilateral onset of symptoms.
3. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L (greater than or equal to 1.0 x 10^9/L for Black population)

Inclusion criterion for treatment-naïve patients only:

1. At an early stage of the disease, without motor fluctuations

Inclusion criteria for non-treatment-naïve patients only:

1. 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 total daily dose of up to 600 mg:
- Dopaminergic agonist alone
- L-dopa alone
- Combination therapy with dopaminergic agonist and L-dopa
- Rasagiline
2. At an early stage of the disease, without motor fluctuations and/or L-dopa–induced dyskinesia

Exclusion Criteria

Main exclusion criteria (all patients):

1. Diagnosis of Parkinson’s disease more than 3 years prior to screening visit
2. Hoehn and Yahr stage greater than or equal to 3 in the Off” state, indicating the need for walking assistance in the absence of treatment.
3. Atypical or secondary Parkinsonism without dopa-sensitivity (e.g., vascular parkinsonism, supranuclear palsy, multisystem atrophy)
4. 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
5. Current treatment with bromocriptine
6. 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.)
7. Current use of a Deep Brain Stimulation (DBS) system. (Patients who previously had a DBS system but have had it removed may be enrolled.)

Exclusion criteria for treatment-naïve patients only:

1. Previous or current treatment with antiparkinsonian medication, or likely to require such medication over the duration of the trial
2. Current treatment with coenzyme Q10 at any dosage. (Patients who are on this medication at a dosage <300 mg/day but stop taking it at least 2 weeks prior to the first dose of study medication may be enrolled.)

Exclusion criteria for non-treatment-naïve patients only:

1. Not stabilized in terms of the current antiparkinsonian therapeutic regimen, and likely to require any change in dopamine therapy over the duration of the trial
2. Current treatment with any antiparkinsonian drug other than those listed in the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change from baseline to Month 9 in the motor examination subscale (Part III) of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).[Baseline and Month 9]