Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia

PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

November 2, 2021

Primary Completion Date

January 13, 2025

Study Completion Date

January 27, 2025

Conditions
Parkinson DiseaseDyskinesia, Medication-Induced
Interventions
DRUG

CPL500036 - low dose

CPL500036 will be given orally. Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily.

DRUG

CPL500036 - high dose

CPL500036 will be given orally. Each patient is to take 4 capsules with active substance daily.

DRUG

Placebo

Placebo will be given orally. Each patient is to take 4 capsules of placebo daily.

Trial Locations (16)

10002

"Communal Enterprise Hospital of Zhytomyr City Council", Zhytomyr

18009

Cherkasy Regional Hospital of the Cherkasy Regional Council, Cherkasy

21050

"Medical Center of the Limited Liability Company Salyutem Medical Center", Vinnytsy

36011

Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of the Poltava Regional Council, Poltava

49027

Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine, Department of Neurology and Borderline Conditions;, Dnipro

61068

Institute of Neurology, Psychiatry and Narcology of the Academy of Medical Sciences of Ukraine, Department of Vascular Pathology of the Brain and Rehabilitation, Kharkiv

69035

"INET-09 LLC (Medical Center)", Zaporizhzhia

69063

"Educational and Scientific Medical Center University Clinic of Zaporizhzhia State Medical University", Zaporizhzhia

76493

"Treatment and Diagnostic Centre Neuro Global of the Limited Liability Company Neuro Global, Treatment and Prevention Sub-division", Ivano-Frankivsk

79010

"Municipal non-profit enterprise of Lviv regional council Lviv regional clinical hospital, Neurological Department", Lviv

880000

"Limited Liability Company, Medical Center DIAMED", Uzhhorod

03-242

Mazowiecki Szpital Bródnowski, Warsaw

32-600

Instytut Zdrowia dr Boczarska-Jedynak Sp. Z o.o., Sp. K.,, Oświęcim

03151

"Medical center Dobrobut-Polyclinic Medical diagnostic center Dobrobut", Kyiv

04050

"Medical Center of the Limited Liability Company Medical Center Consilium Medical", Kyiv

04114

"D.F. Chebotaryov Institute of Gerontology of the National Academy of Medical Sciences of Ukraine", Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Center for Research and Development, Poland

OTHER

lead

Celon Pharma SA

INDUSTRY