Status:
COMPLETED
Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Sleep Disturbances
Parkinsons's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief 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 disrup...
Detailed Description
Sleeping disorders are very common in patients with Parkinson's Disease (PD). Mainly initiation and maintenance of sleep is disturbed, therefore many patients suffer from daytime sleepiness and sleep ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01442610
Start Date
October 1 2011
End Date
September 1 2015
Last Update
January 21 2016
Active Locations (1)
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1
Dresden University of Technology, Dept. of Neurology
Dresden, Germany, 01307