Phase II clinical trial to assess anti-dyskinetic efficacy of CPL500036, in patients with levodopa-induced dyskinesia in Parkinson's disease
- Conditions
- evodopa-induced dyskinesia in Parkinson's DiseaseTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-006004-16-PL
- Lead Sponsor
- Celon Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 108
1. Provision of signed and dated, written informed consent before any study-specific procedures.
2. Patient has a diagnosis of clinically probable or definitive, idiopathic Parkinson’s disease, according to the United Kingdom Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
3. Patient has to be on L-dopa treatment for at least 3 years prior to Screening.
4. Patient must be on a stable dose of L-dopa with aromatic L-amino acid decarboxylase (AADC) inhibitors for at least 28 days before Screening. Patient might get additional catechol-O-methyltransferase (COMT) inhibitors on a stable dose.
5. The total cumulated optimized daily dose of L-dopa should be between 300 to 1600 mg divided into a minimum of 3 doses for at least 28 days before Screening. The L-dopa formulation may include immediate and extended-release forms.
6. In case a patient is on concomitant antiparkinsonian drugs, these concomitant drug doses should be optimized and stable i.e. dopamine agonists treating Parkinson’s disease-related motor and non-motor symptoms for at least 28 days before Screening.
7. Patient has been treated with L-dopa and is suffering from temporally predictable peak-dose LID. The patient should have mild to moderate LID specifically predictable peak-dose dyskinesia (at least two 30-minute intervals of ON time with troublesome dyskinesia between the hours of 09:00 am to 06:00 pm, at least 2 days during the period of Baseline hospitalization (within Days -3 to -1), documented in a Hauser Subject Diary).
8. Patient must consider the dyskinesia to be problematic or disabling for at least 3 months prior to Screening.
9. Score of dyskinesia is at least 2 on part IV, item 4.2 (functional impact of dyskinesia) of the MDS-UPDRS at Screening and on Day -1.
10. Patient with Hoehn-Yahr stages 2 to 4 (in OFF stage).
11. Male or female patient aged 50 to 80 years, inclusive, at Screening.
12. Female patient is eligible to participate if she is not pregnant (negative pregnancy test at Screening and Day -1), not breastfeeding and at least 1 of the following conditions applies:
Woman of non childbearing potential.
Woman of childbearing potential, who agrees to use 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).
13. Male patient must agree to use a barrier method of contraceptive (condom + spermicide gel) for at least 90 days after the last dose of the study drug.
14. Patient agrees to blood sample collection for DNA analysis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
1.Patient has (suspected) atypical Parkinson’s disease.
2.Patient has a history of neurosurgical intervention because of Parkinson’s disease (e.g. deep brain stimulation [DBS]).
3.Transcranial magnetic stimulation was applied within 6 months prior to Screening.
4.Patient has a history of L-dopa or dopaminergic agonist therapy-induced psychotic event, impulse control disorder.
5.Patient has exclusively diphasic, off state, myoclonic, dystonic or akathetic dyskinesia or early morning dystonia without peak-dose dyskinesia.
6.The patient has any moderate or severe neuromuscular, locomotor disease (e.g., chronic, severe rheumatoid arthritis), which might interfere with the study scoring.
7.Patient has a history of severe head injury, stroke or any diagnosis of significant nervous system disease which, in the opinion of the Investigator can affect the patient cognition or motor function of any time.
8.Patient has positive urine drug results (illicit, illegal or without a valid prescription or medical need) at Screening and Baseline.
9.Patient has a history of substance abuse or alcohol abuse within 12 months prior to Screening.
10.If female, the patient is pregnant or lactating or intending to become pregnant (a positive pregnancy test at Screening or Day 1), or intending to donate ova, before or during the course of the study or within 12 weeks after final administration of IMP or placebo.
11.Patient has a history of or known personality disorder or other psychiatric disorder that, in the opinion of the Investigator, would interfere with participation in the study.
12.Patient has a history of neuroleptic malignant syndrome.
13.The patient has any condition that may interfere with the absorption of study medication.
14.Patient with the presence of cognitive impairment, as evidenced by a Mini-Mental State Exam (MMSE) of less than 19.
15.Patient is considered by the Investigator to be at risk of suicide or injury to self, others, or property or participants who within the past year prior to Screening have attempted suicide or have positive answers on item 4 or 5 on the Columbia Suicide Severity Rating Scale (C SSRS) at Screening(for the last 6 month period) or Day 1.
16.Patient has any existing or previous history of cancer that has been in remission for less than 5 years prior to Screening.
Note: This criterion does not include those participants with basal cell, stage I squamous cell skin cancer or in situ cervical cancer.
17.Patient has a medical relevant abnormal electrocardiogram (ECG) that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any patient with any of the following findings will be excluded:
17.1.QT interval corrected for heart rate using Fridericia’s formula (QTcF) interval > 450 msec.
17.2.Bundle branch blocks and other conduction abnormalities that are clinically significant according to the Investigator and/or with a PR interval =220 msec, irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats in the judgment of the Investigator, or T-wave configurations are not of sufficient quality for assessing QT interval duration.
17.3.Patient has a history of unexplained syncope or known family history of sudden death due to long QT syndrome.
18.The patients has acute or chronic hepatitis B or C infection (positive test for hepatitis B surface antigen; positive hepatitis C antibody), kn
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method