- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05297201
Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients With Levodopa Induced Dyskinesia
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: CROS CRO Sp. z o. o.
- Phone Number: +48 796 197 603
- Email: info@cros-cro.com
Study Locations
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Lubelskie
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Lublin, Lubelskie, Poland, 20-954
- Withdrawn
- Samodzielny Publiczny Szpital Kliniczny nr 4
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Mazowieckie
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Warszawa, Mazowieckie, Poland, 03-242
- Recruiting
- Mazowiecki Szpital Bródnowski
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Warszawa, Mazowieckie, Poland, 02-957
- Withdrawn
- Instytut Psychiatrii i Neurologii
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Małopolska
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Oświęcim, Małopolska, Poland, 32-600
- Recruiting
- Instytut Zdrowia dr Boczarska-Jedynak Sp. Z o.o., Sp. K.,
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Dnipro, Ukraine, 49027
- Recruiting
- Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine, Department of Neurology and Borderline Conditions;
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Ivano-Frankivsk, Ukraine, 76493
- Recruiting
- Treatment and Diagnostic Centre "Neuro Global" of the Limited Liability Company "Neuro Global", Treatment and Prevention Sub-division
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Kharkiv, Ukraine, 61068
- Recruiting
- Institute of Neurology, Psychiatry and Narcology of the Academy of Medical Sciences of Ukraine, Department of Vascular Pathology of the Brain and Rehabilitation
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Lviv, Ukraine, 79010
- Recruiting
- Municipal non-profit enterprise of Lviv regional council "Lviv regional clinical hospital", Neurological Department
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Uzhgorod, Ukraine, 880000
- Terminated
- Limited Liability Company, Medical Center "DIAMED"
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Zaporizhzhia, Ukraine, 69035
- Recruiting
- "INET-09" LLC (Medical Center)
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Zaporizhzhia, Ukraine, 69063
- Recruiting
- Educational and Scientific Medical Center "University Clinic" of Zaporizhzhia State Medical University
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Zhytomyr, Ukraine, 10002
- Recruiting
- Communal Enterprise "Hospital" of Zhytomyr City Council
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CPL500036 low dose
Patients will receive 20 mg of CPL500036 administered once daily for 28-days treatment period.
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CPL500036 will be given orally.
Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily.
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Experimental: CPL500036 high dose
Patients will receive 40 mg of CPL500036 administered once daily for 28-days treatment period.
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CPL500036 will be given orally.
Each patient is to take 4 capsules with active substance daily.
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Placebo Comparator: Placebo
Patients will receive placebo administered once daily for 28-days treatment period.
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Placebo will be given orally.
Each patient is to take 4 capsules of placebo daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in total UDysRS score at Week 4.
Time Frame: Day -1, Day 28
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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.
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Day -1, Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in UDysRS objective sub-scale scores Part 3 and 4.
Time Frame: Day -1, Week 1, 2, 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.
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Day -1, Week 1, 2, 3 and 4
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Change from baseline in MDS-UPDRS total score at Week 4
Time Frame: Day -1, Day 28
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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).
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Day -1, Day 28
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Change from baseline in MDS-UPDRS Part 4/A scores at Week 4
Time Frame: Day -1, Day 28
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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).
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Day -1, Day 28
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Change from baseline in Hauser Subject Diary data in ON time with and without dyskinesia or with non-troublesome dyskinesia.
Time Frame: up to 6 weeks
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The Hauser Diary is use to monitor motor fluctuation.
Patients are asked to characterize their prevailing motor states in 30-minute intervals.
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up to 6 weeks
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Adverse events assessment
Time Frame: up to 6 weeks
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Number of all of adverse events will be assessed.
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up to 6 weeks
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Cmax - maximum CPL500036 plasma concentration
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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The maximum concentration of the CPL500036 compound in plasma after IMP administration, obtained directly from the measured concentrations.
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up to 24 hours post administration on Day 1 and Day 7
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Tmax - time to reach maximum CPL500036 concentration
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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The Tmax is time to reach the maximum plasma concentration (Cmax), obtained directly from the actual sampling times.
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up to 24 hours post administration on Day 1 and Day 7
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AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24 hours after IMP administration for CPL500036
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after IMP administration.
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up to 24 hours post administration on Day 1 and Day 7
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AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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The AUC(0-inf) is a measure of total plasma exposure to the drug from time point zero extrapolated to infinity.
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up to 24 hours post administration on Day 1 and Day 7
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Kel - terminal elimination rate constant
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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Kel is to be estimated via linear regression of time versus log of concentration.
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up to 24 hours post administration on Day 1 and Day 7
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Apparent terminal elimination half-life (T1/2) for CPL500036 compound
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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T1/2 is to be calculated as 0.693/Kel.
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up to 24 hours post administration on Day 1 and Day 7
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Apparent clearance (CL/F) for CPL500036 compound
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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Apparent clearance is to be calculated as Dose/AUC(inf)
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up to 24 hours post administration on Day 1 and Day 7
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Apparent volume of distribution during the terminal phase (Vz/F) for CPL500036 compound
Time Frame: up to 24 hours post administration on Day 1 and Day 7
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Apparent volume of distribution is to be calculated as (CL/F)/ Kel
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up to 24 hours post administration on Day 1 and Day 7
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C(trough) - CPL500036 concentration before dosing
Time Frame: Day 1 and Day 7
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The concentration of CPL500036 on day before product administration.
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Day 1 and Day 7
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Change from baseline in inflammatory cytokines level at Week 4
Time Frame: Day 1, Day 28
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Determination of the effect of low and high dose of CPL500036 compared to placebo, on the change in concentration of inflammatory cytokines in blood.
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Day 1, Day 28
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Number of abnormal clinically significant findings (physical, neurological, ophthalmological and dermatological examinations).
Time Frame: Up to 6 weeks
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Up to 6 weeks
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Number of abnormal clinically significant findings in clinical laboratory assessments (hematology, coagulation, clinical chemistry, urinalysis).
Time Frame: Up to 6 weeks
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Up to 6 weeks
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Number of abnormal clinically significant findings in electrocardiogram results.
Time Frame: Up to 6 weeks
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The following electrocardiogram parameters will be assess: PR interval, QRS interval, RR interval, QT interval and QTc interval.
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Up to 6 weeks
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Number of abnormal clinically significant findings in vital signs assessments (respiratory, body temperature, blood pressure, pulse).
Time Frame: Up to 6 weeks
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Up to 6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Drug-Related Side Effects and Adverse Reactions
- Poisoning
- Neurotoxicity Syndromes
- Parkinson Disease
- Dyskinesias
- Dyskinesia, Drug-Induced
Other Study ID Numbers
- 03PDE2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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