Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease

NCT01442610 | Completed Phase 4 DMC

• 1 other identifier: TUD-RaSPar-051
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sleep Disturbances; Parkinsons's Disease

Keywords

Rasagiline; Sleep disorder; Parkinson's disease; Sleep Disturbances in patients with parkinsons's disease

Outcome Measures

Primary Outcomes (2)

• Change in sleep efficacy

  Change from baseline in sleep efficacy (% in time in bed (TIB) / sleep partial time (SPT)) in polysomnography at 8 weeks

  baseline and 8 weeks

• Change in PDSS-2

  Change from baseline in sleep quality at 8 weeks

  Baseline and 8 weeks

Secondary Outcomes (3)

• Change in other sleep parameters

  baseline and 8 weeks

• Electrocardiography

  baseline and 8 weeks

• Laboratory parameter

  baseline and 8 weeks

Study Arms (2)

Rasagiline

EXPERIMENTAL

Effect of Rasagiline on sleep parameters in PD Patients

Drug: Rasagiline

Placebo

PLACEBO COMPARATOR

Effect of placebo on sleep parameters in PD Patients

Drug: Placebo

Interventions

Rasagiline DRUG

Rasagiline tablets 1mg once daily for 8 weeks

Also known as: Azilect

Rasagiline

Placebo DRUG

Placebo 1tablet once daily for 8 weeks

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Dresden University of Technology, Dept. of Neurology

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Parasomnias; Sleep Wake Disorders; Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Alexander Storch, MD

  Dresden University of Technology, Dept. of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 28, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

DE (1)