Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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Sleep-wake disturbances (SWD) are frequent in Parkinson's disease (PD) and affect the quality of life of affected patients. Rasagiline is a potent, highly selective, irreversible, second-generation, monoamine oxidase type-B (MAO-B) inhibitor with a 24h dopaminergic effect. It is well known that dopaminergic treatment closely interacts with SWD. This study aims to assess the effect of Rasagiline on SWD in PD patients. In this randomized, double-blind, placebo controlled study in clinical phase IV, 60 subjects will be treated with rasagiline 1mg po once daily or placebo over 8 weeks. The study is planned to be conducted in 6-9 Swiss centers. Questionaires will be used to assess SWDs: sleep disturbances (Parkinson's Disease Sleep Scale, PDSS), daytime sleepiness (Epworth Sleepiness Scale, ESS), fatigue (Fatigue Severity Scale, FSS), apathy (Apathy Evaluation Scale Self, AES-S), disability (Sheehan scale) and QoL in PD patients. Trial with medicinal product

Official Title
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A Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD)

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Rasagiline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Probable diagnosis of Parkinson's disease according to the modified UK Parkinson's Disease Society Brain Bank criteria Hoehn and Yahr up to stage 3 in the off-state Age = 40 years On the basis of a physical examination and medical history, the patient is in the investigator's opinion otherwise healthy Parkinson's Disease Sleep Scale (PDSS) score = 90. Patients with stable dosage of hypnotics / sedative /neuropsychiatric treatment including antiParkinsonian treatment in the last 4 weeks before screening evaluation and with no change foreseen during the study period. Dose adjustments can be made, but no change or discontinuation of drugs. Subjects must understand questionnaires in German, French or Italian Provided signed informed consent Females of childbearing potential must agree to utilize highly effective contraceptive methods of birth control. Females of child bearing potential must have a negative pregnancy test. Exclusion criteria: Diagnosis unclear or suspicion of another than Parkinson's disease Patients with cognitive deficit (MMSE < 26) Patients who have undergone surgery for the treatment of PD Patients with non-response to adequate antiParkinsonian treatment History of moderate to severe hepatic insufficiency. Clinically relevant or unstable vascular disease History of drug or alcohol abuse (within the past 10 years) Patients with a history of psychotic disorders Patients with treatment resistant/recurrent major depression (HADS =19) Patients with unstable dosage of antiParkinsonian or neuropsychiatric treatment in the last 4 weeks before screening evaluation. Concomitant use of fluoxetine, fluvoxamine, pethidine or monoamine oxidase inhibitors (MAOI) during the course of the study and within 3 months prior to screening evaluation. Patient may be rescreened 3 months after discontinuation of the above mentioned drugs. Concomitant use of dextromethorphan, ephedrine or pseudoephedrine during the course of the study Women who are pregnant or lactating Participation in another study during or up to 30 days prior to participation in this study

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rasagiline<br> | Drug: Rasagiline<br>* Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Rasagiline<br>* Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS) | Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS) | Baseline after 8 weeks of treatment |