A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215

ApoPharma0 个研究点目标入组 140 人开始时间: 2016年2月16日最近更新: 2020年10月13日

适应症

试验速览

暂无简介。

•1. Male or female aged =18 to < 80 years
•2. Body weight =60 kg but =100 kg
•3. 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, patient must have unilateral onset of symptoms.
•4. Absolute neutrophil count (ANC) =1.5 x 109/L (=1.0 x 109/L for Black population) at screening
•5. 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:
•o Dopaminergic agonist alone
•o L-dopa alone
•o Combination therapy with dopaminergic agonist and L-dopa
•o Rasagiline
•o At an early stage of the disease, without motor fluctuations and/or L-dopa–induced dyskinesia
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 82
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 58

•1. Diagnosis of Parkinson’s disease more than 3 years prior to screening visit
•2. Hoehn and Yahr stage = 3
•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. 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
•6. Current treatment with bromocriptine
•7. Current treatment with any antiparkinsonian drug other than those listed in the inclusion criteria
•8. 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.)
•9. Current use of a Deep Brain Stimulation (DBS) system. (Patients who previously had a DBS system but have had it removed may be enrolled.)

发起方