Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia (NCT05297201) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia
Poland, Ukraine105 participantsStarted 2021-11-02
Plain-language summary
The aim of the study is to determine potential anti-dyskinetic properties of CPL500036 (PDE10A inhibitor) in Parkinson disease patients suffering from levodopa Induced dyskinesia. The study is to determine the efficacy and dose response of two CPL500036 doses, compared with placebo.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. Signed and dated written informed consent.
✓. Male or female patient aged between 50 and 80, diagnosed of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
✓. The patient is on stable dose of Levodopa.
✓. Other anti-PD medications are allowed if dosing is optimized and stably used.
✓. The patient is has been treated with Levodopa and is suffering from temporally predictable peak-dose LID.
✓. Patient declare that dyskinesia is problematic or disabling.
✓. Score of dyskinesia is at least 2 on part IV, item 4.2 (of the MDS-UPDRS at Screening and on Day -1).
✓. Patient with Hoehn-Yahr stages 2 to 4 (in OFF stage).
Exclusion criteria
✕. The patient has (suspected) atypical Parkinson's disease.
✕. The patient has a history of neurosurgical intervention because of Parkinson's disease.
✕. Patient has unstable medical status which may impact the ability of the patients to participate or potentially confound the study result.
✕. Patient has a history of psychotic event induced by anti-PD treatments or impulse control disorder.
What they're measuring
1
Change from baseline in total UDysRS score at Week 4.