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

NCT05297201 | Completed Phase 2

• 1 other identifier: 03PDE2020
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 16

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 determine the efficacy and dose response of two CPL500036 doses, compared with placebo.

Conditions

Parkinson Disease; Dyskinesia, Medication-Induced

Keywords

Parkinson's; Levodopa induced dyskinesia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total UDysRS score at Week 4.

  Determination of the effect of low and high dose of CPL500036 compared to placebo, on the reduction of dyskinesia based on Unified Dyskinesia Rating Scale (UDysRS). The UDysRR scale is used to measure dyskinesia in Parkinson disease. Within a single scale, rater is to evaluate patient perceptions, time factors, anatomical distribution, objective impairment, severity, and disability which are accordingly divided into Part 1, Part 2, Part 3 and Part 4 of the UDysRS scale, respectively.

  Day -1, Day 28

Secondary Outcomes (19)

• Change from baseline in UDysRS objective sub-scale scores Part 3 and 4.

  Day -1, Week 1, 2, 3 and 4

• Change from baseline in MDS-UPDRS total score at Week 4

  Day -1, Day 28

• Change from baseline in MDS-UPDRS Part 4/A scores at Week 4

  Day -1, Day 28

• Change from baseline in Hauser Subject Diary data in ON time with and without dyskinesia or with non-troublesome dyskinesia.

  up to 6 weeks

• Adverse events assessment

  up to 6 weeks

Study Arms (3)

CPL500036 low dose

EXPERIMENTAL

Patients will receive 20 mg of CPL500036 administered once daily for 28-days treatment period.

Drug: CPL500036 - low dose

CPL500036 high dose

EXPERIMENTAL

Patients will receive 40 mg of CPL500036 administered once daily for 28-days treatment period.

Drug: CPL500036 - high dose

Placebo

PLACEBO COMPARATOR

Patients will receive placebo administered once daily for 28-days treatment period.

Drug: Placebo

Interventions

CPL500036 - low dose DRUG

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

CPL500036 low dose

CPL500036 - high dose DRUG

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

CPL500036 high dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celon Pharma SA: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (16)

Mazowiecki Szpital Bródnowski

Warsaw, Masovian Voivodeship, 03-242, Poland

Location

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

Oświęcim, Małopolska, 32-600, Poland

Location

Cherkasy Regional Hospital of the Cherkasy Regional Council

Cherkasy, 18009, Ukraine

Location

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, 49027, Ukraine

Location

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

Ivano-Frankivsk, 76493, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

"Medical center "Dobrobut-Polyclinic" "Medical diagnostic center "Dobrobut"

Kyiv, 03151, Ukraine

Location

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

Kyiv, 04050, Ukraine

Location

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

Kyiv, 04114, Ukraine

Location

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

Lviv, 79010, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

Limited Liability Company, Medical Center "DIAMED"

Uzhhorod, 880000, Ukraine

Location

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

Vinnytsy, 21050, Ukraine

Location

"INET-09" LLC (Medical Center)

Zaporizhzhia, 69035, Ukraine

Location

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

Zaporizhzhia, 69063, Ukraine

Location

Communal Enterprise "Hospital" of Zhytomyr City Council

Zhytomyr, 10002, Ukraine

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesia, Drug-Induced

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Neurotoxicity Syndromes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 28, 2022
• Study Start: November 2, 2021
• Primary Completion: January 13, 2025
• Study Completion: January 27, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-02

Locations

PL (2); UA (14)