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Status:

COMPLETED

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

Lead Sponsor:

Celon Pharma SA

Collaborating Sponsors:

National Center for Research and Development, Poland

Conditions:

Parkinson Disease

Dyskinesia, Medication-Induced

Eligibility:

All Genders

50-80 years

Phase:

PHASE2

Brief 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 dete...

Detailed Description

This is a double-blind, randomized, placebo-controlled, parallel-group, dose ranging study, to explore the efficacy, safety, tolerability and pharmacokinetic (PK) of low and high dose of CPL500036 an ...

Eligibility Criteria

Inclusion

  • 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).
  • Female patient is not pregnant (at Screening and Day -1), not breastfeeding and at least 1 of the following conditions applies: (i) woman of non-childbearing potential; (ii) woman of childbearing potential, using contraceptive methods during the Treatment Period and for at least 28 days after the last dose of the study drug.
  • The following are acceptable contraceptive methods: bilateral tubal occlusion, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices, male or female condom with spermicide; and cap, diaphragm or sponge with spermicide.
  • Male patient must agree to use a barrier method of contraceptive for at least 90 days after the last dose of the study drug.
  • Patient agrees to blood sample collection for DNA analysis.
  • 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.
  • The patient has any moderate or severe neuromuscular, locomotor disease, that interfere with the study scoring.
  • The Patient has a history of severe head injury, stroke or any diagnosis of significant nervous system disease.
  • Patient has a history of substance abuse or alcohol abuse within 12 months prior to Screening.
  • The patient is pregnant or lactating or intending to become pregnant or intending to donate ova.
  • Patient has a history of neuroleptic malignant syndrome, or known personality disorder, or other psychiatric disorder that, in the opinion of the Investigator, would interfere with participation in the study.
  • Patient with the presence of cognitive impairment evidenced by a Mini-Mental State Exam (MMSE) of less than 19.
  • Patients is considered by the Investigator to be at imminent risk of suicide or injury to self or others.
  • Patients has any existing or previous history of cancer or has newly diagnosed diabetes.
  • Patient has abnormal ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study.
  • Patient has abnormal QT interval, history of unexplained syncope or known family history of sudden death due to QT abnormality.
  • The patient has any laboratory values outside the normal range that are considered by Investigator to be clinically significant at Screening.
  • Patient participated in another interventional clinical study with an IMP

Exclusion

    Key Trial Info

    Start Date :

    November 2 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 27 2025

    Estimated Enrollment :

    105 Patients enrolled

    Trial Details

    Trial ID

    NCT05297201

    Start Date

    November 2 2021

    End Date

    January 27 2025

    Last Update

    March 4 2025

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    1

    Mazowiecki Szpital Bródnowski

    Warsaw, Masovian Voivodeship, Poland, 03-242

    2

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

    Oświęcim, Małopolska, Poland, 32-600

    3

    Cherkasy Regional Hospital of the Cherkasy Regional Council

    Cherkasy, Ukraine, 18009

    4

    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, Ukraine, 49027