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

Primary Purpose

Parkinson Disease, Dyskinesia, Medication-Induced

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CPL500036 - low dose
CPL500036 - high dose
Placebo
Sponsored by
Celon Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's, Levodopa induced dyskinesia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Signed and dated written informed consent.
  2. 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.
  3. The patient is on stable dose of Levodopa.
  4. Other anti-PD medications are allowed if dosing is optimized and stably used.
  5. The patient is has been treated with Levodopa and is suffering from temporally predictable peak-dose LID.
  6. Patient declare that dyskinesia is problematic or disabling.
  7. Score of dyskinesia is at least 2 on part IV, item 4.2 (of the MDS-UPDRS at Screening and on Day -1).
  8. Patient with Hoehn-Yahr stages 2 to 4 (in OFF stage).
  9. 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.

  10. Male patient must agree to use a barrier method of contraceptive for at least 90 days after the last dose of the study drug.
  11. Patient agrees to blood sample collection for DNA analysis.

Exclusion criteria:

  1. The patient has (suspected) atypical Parkinson's disease.
  2. The patient has a history of neurosurgical intervention because of Parkinson's disease.
  3. Patient has unstable medical status which may impact the ability of the patients to participate or potentially confound the study result.
  4. Patient has a history of psychotic event induced by anti-PD treatments or impulse control disorder.
  5. The patient has any moderate or severe neuromuscular, locomotor disease, that interfere with the study scoring.
  6. The Patient has a history of severe head injury, stroke or any diagnosis of significant nervous system disease.
  7. Patient has a history of substance abuse or alcohol abuse within 12 months prior to Screening.
  8. The patient is pregnant or lactating or intending to become pregnant or intending to donate ova.
  9. 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.
  10. Patient with the presence of cognitive impairment evidenced by a Mini-Mental State Exam (MMSE) of less than 19.
  11. Patients is considered by the Investigator to be at imminent risk of suicide or injury to self or others.
  12. Patients has any existing or previous history of cancer or has newly diagnosed diabetes.
  13. Patient has abnormal ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study.
  14. Patient has abnormal QT interval, history of unexplained syncope or known family history of sudden death due to QT abnormality.
  15. The patient has any laboratory values outside the normal range that are considered by Investigator to be clinically significant at Screening.
  16. Patient participated in another interventional clinical study with an IMP

Sites / Locations

  • Samodzielny Publiczny Szpital Kliniczny nr 4
  • Instytut Psychiatrii i Neurologii
  • Mazowiecki Szpital BródnowskiRecruiting
  • Instytut Zdrowia dr Boczarska-Jedynak Sp. Z o.o., Sp. K.,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;Recruiting
  • Treatment and Diagnostic Centre "Neuro Global" of the Limited Liability Company "Neuro Global", Treatment and Prevention Sub-divisionRecruiting
  • Institute of Neurology, Psychiatry and Narcology of the Academy of Medical Sciences of Ukraine, Department of Vascular Pathology of the Brain and RehabilitationRecruiting
  • Municipal non-profit enterprise of Lviv regional council "Lviv regional clinical hospital", Neurological DepartmentRecruiting
  • Limited Liability Company, Medical Center "DIAMED"
  • "INET-09" LLC (Medical Center)Recruiting
  • Educational and Scientific Medical Center "University Clinic" of Zaporizhzhia State Medical UniversityRecruiting
  • Communal Enterprise "Hospital" of Zhytomyr City CouncilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CPL500036 low dose

CPL500036 high dose

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).
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.
Adverse events assessment
Number of all of adverse events will be assessed.
Cmax - maximum CPL500036 plasma concentration
The maximum concentration of the CPL500036 compound in plasma after IMP administration, obtained directly from the measured concentrations.
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.
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.
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.
Kel - terminal elimination rate constant
Kel is to be estimated via linear regression of time versus log of concentration.
Apparent terminal elimination half-life (T1/2) for CPL500036 compound
T1/2 is to be calculated as 0.693/Kel.
Apparent clearance (CL/F) for CPL500036 compound
Apparent clearance is to be calculated as Dose/AUC(inf)
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
C(trough) - CPL500036 concentration before dosing
The concentration of CPL500036 on day before product administration.
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.
Number of abnormal clinically significant findings (physical, neurological, ophthalmological and dermatological examinations).
Number of abnormal clinically significant findings in clinical laboratory assessments (hematology, coagulation, clinical chemistry, urinalysis).
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.
Number of abnormal clinically significant findings in vital signs assessments (respiratory, body temperature, blood pressure, pulse).

Full Information

First Posted
February 17, 2022
Last Updated
June 1, 2023
Sponsor
Celon Pharma SA
Collaborators
National Center for Research and Development, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05297201
Brief Title
Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients With Levodopa Induced Dyskinesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celon Pharma SA
Collaborators
National Center for Research and Development, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dyskinesia, Medication-Induced
Keywords
Parkinson's, Levodopa induced dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPL500036 low dose
Arm Type
Experimental
Arm Description
Patients will receive 20 mg of CPL500036 administered once daily for 28-days treatment period.
Arm Title
CPL500036 high dose
Arm Type
Experimental
Arm Description
Patients will receive 40 mg of CPL500036 administered once daily for 28-days treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo administered once daily for 28-days treatment period.
Intervention Type
Drug
Intervention Name(s)
CPL500036 - low dose
Intervention Description
CPL500036 will be given orally. Each patient is to take 2 capsules with active substance and 2 capsules of placebo daily.
Intervention Type
Drug
Intervention Name(s)
CPL500036 - high dose
Intervention Description
CPL500036 will be given orally. Each patient is to take 4 capsules with active substance daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be given orally. Each patient is to take 4 capsules of placebo daily.
Primary Outcome Measure Information:
Title
Change from baseline in total UDysRS score at Week 4.
Description
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.
Time Frame
Day -1, Day 28
Secondary Outcome Measure Information:
Title
Change from baseline in UDysRS objective sub-scale scores Part 3 and 4.
Description
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.
Time Frame
Day -1, Week 1, 2, 3 and 4
Title
Change from baseline in MDS-UPDRS total score at Week 4
Description
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).
Time Frame
Day -1, Day 28
Title
Change from baseline in MDS-UPDRS Part 4/A scores at Week 4
Description
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).
Time Frame
Day -1, Day 28
Title
Change from baseline in Hauser Subject Diary data in ON time with and without dyskinesia or with non-troublesome dyskinesia.
Description
The Hauser Diary is use to monitor motor fluctuation. Patients are asked to characterize their prevailing motor states in 30-minute intervals.
Time Frame
up to 6 weeks
Title
Adverse events assessment
Description
Number of all of adverse events will be assessed.
Time Frame
up to 6 weeks
Title
Cmax - maximum CPL500036 plasma concentration
Description
The maximum concentration of the CPL500036 compound in plasma after IMP administration, obtained directly from the measured concentrations.
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
Tmax - time to reach maximum CPL500036 concentration
Description
The Tmax is time to reach the maximum plasma concentration (Cmax), obtained directly from the actual sampling times.
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
AUC(0-24) - area under the plasma concentration - time curve from time 0 to 24 hours after IMP administration for CPL500036
Description
The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after IMP administration.
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
AUC(0-inf) - area under the plasma concentration - time curve from time 0 to infinity time for CPL500036
Description
The AUC(0-inf) is a measure of total plasma exposure to the drug from time point zero extrapolated to infinity.
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
Kel - terminal elimination rate constant
Description
Kel is to be estimated via linear regression of time versus log of concentration.
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
Apparent terminal elimination half-life (T1/2) for CPL500036 compound
Description
T1/2 is to be calculated as 0.693/Kel.
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
Apparent clearance (CL/F) for CPL500036 compound
Description
Apparent clearance is to be calculated as Dose/AUC(inf)
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
Apparent volume of distribution during the terminal phase (Vz/F) for CPL500036 compound
Description
Apparent volume of distribution is to be calculated as (CL/F)/ Kel
Time Frame
up to 24 hours post administration on Day 1 and Day 7
Title
C(trough) - CPL500036 concentration before dosing
Description
The concentration of CPL500036 on day before product administration.
Time Frame
Day 1 and Day 7
Title
Change from baseline in inflammatory cytokines level at Week 4
Description
Determination of the effect of low and high dose of CPL500036 compared to placebo, on the change in concentration of inflammatory cytokines in blood.
Time Frame
Day 1, Day 28
Title
Number of abnormal clinically significant findings (physical, neurological, ophthalmological and dermatological examinations).
Time Frame
Up to 6 weeks
Title
Number of abnormal clinically significant findings in clinical laboratory assessments (hematology, coagulation, clinical chemistry, urinalysis).
Time Frame
Up to 6 weeks
Title
Number of abnormal clinically significant findings in electrocardiogram results.
Description
The following electrocardiogram parameters will be assess: PR interval, QRS interval, RR interval, QT interval and QTc interval.
Time Frame
Up to 6 weeks
Title
Number of abnormal clinically significant findings in vital signs assessments (respiratory, body temperature, blood pressure, pulse).
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CROS CRO Sp. z o. o.
Phone
+48 796 197 603
Email
info@cros-cro.com
Facility Information:
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-954
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Mazowiecki Szpital Bródnowski
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-242
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Zdrowia dr Boczarska-Jedynak Sp. Z o.o., Sp. K.,
City
Oświęcim
State/Province
Małopolska
ZIP/Postal Code
32-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine, Department of Neurology and Borderline Conditions;
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Treatment and Diagnostic Centre "Neuro Global" of the Limited Liability Company "Neuro Global", Treatment and Prevention Sub-division
City
Ivano-Frankivsk
ZIP/Postal Code
76493
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Institute of Neurology, Psychiatry and Narcology of the Academy of Medical Sciences of Ukraine, Department of Vascular Pathology of the Brain and Rehabilitation
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal non-profit enterprise of Lviv regional council "Lviv regional clinical hospital", Neurological Department
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Limited Liability Company, Medical Center "DIAMED"
City
Uzhgorod
ZIP/Postal Code
880000
Country
Ukraine
Individual Site Status
Terminated
Facility Name
"INET-09" LLC (Medical Center)
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Educational and Scientific Medical Center "University Clinic" of Zaporizhzhia State Medical University
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Communal Enterprise "Hospital" of Zhytomyr City Council
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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