Phase II trial investigating Uncontrollable voluntary movements in PD
- Conditions
- Parkinson's disease dyskinesiaMedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-002010-41-IT
- Lead Sponsor
- Integrative Research Laboratories Sweden AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
1.Male or female =30 and =79 years of age at the time of screening.
2.Signed a current Ethics Committee approved informed consent form (ICF).
3.PD, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
4.Minimal amount of 2 hours of daily ON-time with troublesome dyskinesia during waking hours.
5.Functional impact of dyskinesias determined as a score of =2 as per Question 4.2 of the MDS-UPDRS.
6.On a stable regimen of antiparkinson medications for at least 30 days prior to first home diary completion including a levodopa preparation administered 3-8 times/day (excluding nighttime levodopa) and willing to continue the same doses and regimens during study participation. Rescue medications such as Madopar dispersable and Apomorphine injections are allowed if prescribed PRN prior study entry.
7.Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to first home diary completion and the patient must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as needed basis).
8.Able to complete 24-hour patient home diaries of which two valid diaries must be presented at Visit 1.
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 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
1.History of neurosurgical intervention related to PD (e.g. deep brain stimulation).
2.Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine or levodopa/carbidopa intestinal infusion).
3.History of seizures within two years prior to screening.
4.History of stroke or transient ischemic attack (TIA) within two years prior to screening.
5.History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non metastatic prostate cancer or in situ cervical cancer.
6.Presence of cognitive impairment, as evidenced by a Mini-Mental State Examination (MMSE) score of less than 24 during screening.
7.A Hoehn and Yahr stage of 5.
8.Ongoing treatment with amantadine at time of screening or within 6 weeks prior first home diary completion.
9.Treatment with Inbrija (inhaled levodopa) at time of screening or within 4 weeks prior first home diary completion.
10.Any history of a significant heart condition or cardiac arrhythmias within the past 5 years, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator.
11.Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease, clinically significant symptomatic orthostatic hypotension; clinically significant hepatic disease, severe renal impairment, i.e. creatinine clearance <30 mL/min.
12.Any history of a neurological other than PD or a psychiatric disorder, including history of Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosed major depression or psychosis. Patients with illusions or hallucinations with no loss of insight will be eligible. Patients with mild depression who are well controlled on a stable dose of an antidepressant medication for at least 4 weeks before screening will be eligible.
13. Enrolment in any other clinical study involving medication, medical devices or surgical procedures, current or within three months prior to screening visit, or previous participation in the present study. Patients enrolled in non-interventional clinical trials will be eligible.
14.Drug and/or alcohol abuse.
15.History of severe drug allergy or hypersensitivity.
16.If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose.
17.Patients unwilling to use two forms of contraception (one of which being a barrier method (see Section 8.1) during the treatment period and 90 days for men and 30 days for women after last IMP dose.
18.Any planned major surgery within the duration of the study.
19.Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgement.
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