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Parkinson DiseasePhase 2NCT05297201

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

A Phase 2 study testing CPL500036 - low dose and CPL500036 - high dose in people with Parkinson Disease and Dyskinesia, Medication-Induced, run by Celon Pharma SA at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
CPL500036 - low dose and CPL500036 - high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
16 sitesin 2 countries
Study dates
2 Nov 2021to 27 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Ukraine14 sites

  • Cherkasy Regional Hospital of the Cherkasy Regional Council

    Cherkasy, 18009

  • 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

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

    Ivano-Frankivsk, 76493

  • 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

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

    Kyiv, 03151

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

    Kyiv, 04050

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

    Kyiv, 04114

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

    Lviv, 79010

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

    Poltava, 36011

  • Limited Liability Company, Medical Center "DIAMED"

    Uzhhorod, 880000

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

    Vinnytsy, 21050

  • "INET-09" LLC (Medical Center)

    Zaporizhzhya, 69035

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

    Zaporizhzhya, 69063

  • Communal Enterprise "Hospital" of Zhytomyr City Council

    Zhytomyr, 10002

Other trials in Ukraine

Poland2 sites

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

    Oświęcim, Małopolska, 32-600

  • Mazowiecki Szpital Bródnowski

    Warsaw, Masovian Voivodeship, 03-242

Other trials in Poland

About this study

Official title: Phase II, Double Blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 (PDE10A Inhibitor) in Patients with Parkinson's Disease Suffering from Levodopa Induced Dyskinesia

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.

Read the 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 phosphodiesterase 10A (PDE10A) inhibitor in Parkinson's disease patients with levodopa induced dyskinesia (LID) when administered for 28 days. The study will be conducted at multiple Clinical Sites. Approximately 108 patients will be randomized at 1:1:1 ratio to receive low or high dose of CPL500036 or placebo in a blinded manner, once daily for 28 days (Day 1 to Day 28). The study will comprise of Screening, Baseline (a 4-day in-house period), a Treatment Period and a Follow-Up Period. The patients will be discharged from clinical units during the Treatment Period. Approximately 30% of the patients (11 patients in each of the 3 treatment groups) will undergo extensive PK blood sampling during the Treatment Period and the remaining 70% of the patients will undergo sparse PK blood sampling. Patients from extensive PK blood sampling will be discharged from the Clinical Site on Day 8 and Day 1 for patients from sparse PK blood sampling group respectively.

Being tested
CPL500036 - low dose, CPL500036 - high dose, Placebo
Keywords
Parkinson's, Levodopa induced dyskinesia
Medical subject headings
Parkinson Disease, Dyskinesia, Drug-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPL500036 - low doseDrug

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

  • CPL500036 - high doseDrug

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

  • PlaceboDrug

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

Study groups in NCT05297201
Study groupRoleWhat they receive
CPL500036 low doseExperimentalPatients will receive 20 mg of CPL500036 administered once daily for 28-days treatment period.
Receives: Drug: CPL500036 - low dose
CPL500036 high doseExperimentalPatients will receive 40 mg of CPL500036 administered once daily for 28-days treatment period.
Receives: Drug: CPL500036 - high dose
PlaceboPlacebo comparatorPatients will receive placebo administered once daily for 28-days treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day -1, Day 28

Secondary outcomes (19)

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

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

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

    Determination of the effect of low and high dose of CPL500036 compared to placebo using Movement Disorders Society (MDS) Modified Unified Parkinson's Disease Rating Scale (MDS-UPDRS). MDS-UPDRS is use to measure the severity and progression of Parkinson disease (PD). The MDS-UPDRS scale contain 4 parts that captures essential features of Parkinson's disease. Within a single scale, rater is to evaluate non-motor (Part 1) and motor (Part 2) experience of daily living, motor examination (Part III) and motor complications (Part IV).

    Measured: Day -1, Day 28

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

    Determination of the effect of low and high dose of CPL500036 compared to placebo using Movement Disorders Society (MDS) Modified Unified Parkinson's Disease Rating Scale (MDS-UPDRS). MDS-UPDRS is use to measure the severity and progression of Parkinson disease (PD). The MDS-UPDRS scale contain 4 parts that captures essential features of Parkinson's disease. Within a single scale, rater is to evaluate non-motor (Part 1) and motor (Part 2) experience of daily living, motor examination (Part III) and motor complications (Part IV).

    Measured: Day -1, Day 28

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

    The Hauser Diary is use to monitor motor fluctuation. Patients are asked to characterize their prevailing motor states in 30-minute intervals.

    Measured: up to 6 weeks

  5. Adverse events assessment

    Number of all of adverse events will be assessed.

    Measured: up to 6 weeks

  6. Cmax - maximum CPL500036 plasma concentration

    The maximum concentration of the CPL500036 compound in plasma after IMP administration, obtained directly from the measured concentrations.

    Measured: up to 24 hours post administration on Day 1 and Day 7

  7. Tmax - time to reach maximum CPL500036 concentration

    The Tmax is time to reach the maximum plasma concentration (Cmax), obtained directly from the actual sampling times.

    Measured: up to 24 hours post administration on Day 1 and Day 7

  8. AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24 hours after IMP administration for CPL500036

    The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after IMP administration.

    Measured: up to 24 hours post administration on Day 1 and Day 7

  9. AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036

    The AUC(0-inf) is a measure of total plasma exposure to the drug from time point zero extrapolated to infinity.

    Measured: up to 24 hours post administration on Day 1 and Day 7

  10. Kel - terminal elimination rate constant

    Kel is to be estimated via linear regression of time versus log of concentration.

    Measured: up to 24 hours post administration on Day 1 and Day 7

  11. Apparent terminal elimination half-life (T1/2) for CPL500036 compound

    T1/2 is to be calculated as 0.693/Kel.

    Measured: up to 24 hours post administration on Day 1 and Day 7

  12. Apparent clearance (CL/F) for CPL500036 compound

    Apparent clearance is to be calculated as Dose/AUC(inf)

    Measured: up to 24 hours post administration on Day 1 and Day 7

  13. Apparent volume of distribution during the terminal phase (Vz/F) for CPL500036 compound

    Apparent volume of distribution is to be calculated as (CL/F)/ Kel

    Measured: up to 24 hours post administration on Day 1 and Day 7

  14. C(trough) - CPL500036 concentration before dosing

    The concentration of CPL500036 on day before product administration.

    Measured: Day 1 and Day 7

  15. Change from baseline in inflammatory cytokines level at Week 4

    Determination of the effect of low and high dose of CPL500036 compared to placebo, on the change in concentration of inflammatory cytokines in blood.

    Measured: Day 1, Day 28

  16. Number of abnormal clinically significant findings (physical, neurological, ophthalmological and dermatological examinations).

    Measured: Up to 6 weeks

  17. Number of abnormal clinically significant findings in clinical laboratory assessments (hematology, coagulation, clinical chemistry, urinalysis).

    Measured: Up to 6 weeks

  18. Number of abnormal clinically significant findings in electrocardiogram results.

    The following electrocardiogram parameters will be assess: PR interval, QRS interval, RR interval, QT interval and QTc interval.

    Measured: Up to 6 weeks

  19. Number of abnormal clinically significant findings in vital signs assessments (respiratory, body temperature, blood pressure, pulse).

    Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start2 Nov 2021
  3. Primary completion13 Jan 2025
  4. Study completion27 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297201
Sponsor's protocol ID
03PDE2020
Status last verified
Feb 2024
First submitted
17 Feb 2022
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPL500036 - low dose and CPL500036 - high dose in people with Parkinson Disease and Dyskinesia, Medication-Induced, run by Celon Pharma SA at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Ukraine, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in total UDysRS score at Week 4. (time frame: Day -1, Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

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