Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

As the MAO-B inhibitor rasagiline is able to improve motor skills it might have positive effects on sleep disruption by reducing nocturnal akinesia. As it was reported to cause only minor sleep disruption in PD Patients, it might be able to improve sleep architecture. The investigators thus study the effects of Rasagiline on sleep disturbances measured by polysomnographic (PSG) evaluation of sleep efficacy and PDSS-2. Secondary measures are other sleep variables measured by PSG, sleep quality and daytime sleepiness assessed by standardized scales as well as cognitive function, depression and QoL index.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Rasagiline

Criteria

Inclusion Criteria:

• Male or female outpatients

• Age from 50 to 85 years

• Definite Parkinson's disease according to UK brain bank criteria

• Hoehn & Yahr I-III

• Relevant sleep disturbance (> 5 point in PSQI)

• Patient must be able to complete questionaires

• Stable antiparkinsonian medication for at least 4 weeks prior to screening

• Antiparkinsonian medication should be stable 30 days prior to screening until 10 days after end of study

• Written informed consent

Exclusion Criteria:

• Overreaction/allergies to study drug or one of its components

• Pregnancy and/or lactation period

• Women with childbearing potential not practicing an acceptable method of contraception (Pearl-Index <1)

• Non-permitted medication within two weeks prior to study inclusion and during study:

Hypnotics, Amantadine, MAO inhibitors, SSRIs, SNRIs, tricyclic and tetracyclic antidepressants, all neuroleptics except clozapine and quetiapine

• Non-permitted medication during study: CYP P450 1A2 inhibitors (a.e. Ciprofloxacin, Cimetidine, Clarithromycin, Erythromycin, systemic Estrogen, Fluvoxamine, Isoniazid, Ketoconazole, Levofloxacin, Norfloxacin, Mexiletine, Paroxetine, Propafenone, Zileuton, Disulfiram, Ginseng, grapefruit juice, Ephedrine).

• Planned participation or participation in another clinical trial during the last 4 weeks prior to screening and during the whole trial period

• Epilepsy or epileptic seizure in the history

• Significant renal or hepatic impairment

• Legal incapacity or limited legal capacity

• Dementia or other psychiatric illness that prevent from giving informed consent.

• Any clinically significant medical illnesses which interfere with capability to participate in study

• History of sleep related breathing disorder or severe OSAS as characterized by PSG (> 30 AHI)

• Severe Depression (BDI > 17)

• Known history of cardiac arrhythmias, angina pectoris, narrow angle glaucoma, residual urine caused by benign prostatic hyperplasia, pheochromocytoma

• Patients requiring elective surgery requiring general anaesthesia during study period