- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442610
Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease (RaSPar)
Effects of Rasagiline on Sleep Disturbances in PD: A Single Center, Randomized, Double-blind, Placebo run-in, Polysomnographic Clinical Phase IV Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 attacks. Polysomnographic studies showed increased sleep fragmentation and frequent awakenings, increased amount of wakefulness during time in bed as well as reduced sleep efficacy and deep sleep time. In addition, increased sleep latency, REM-latency and decreased amounts of REM sleep were documented.
PD patients also suffer from primary sleep disorders like sleep disordered breathing and especially REM sleep behaviour disorder (RBD)and periodic limb movements in sleep (PLMS).
Not only neurochemical changes affecting cholinergic and monoaminergic systems, nocturnal hypokinesia and rigidity and painful dystonia due to the disease itself, but also medication side effects lead to impaired sleep-wake-control and reduced REM sleep.
Although levodopa medication and dopamine agonists reduce nocturnal hypokinesia and therefore improve insomnia they also have a potential impact on daytime sleepiness and are able to cause sleep disruption. The impact of dopaminergic therapy is complex showing biphasic effects with increased wakefulness and decreased REM-sleep frequency via stimulation of dopamine D1 receptors whereas low doses promote sleep via dopamine D2 receptors. In addition, acting of dopamine agonists via dopamine D3 receptors might be responsible for daytime sleepiness and sleep attacks.
However, as stimulation of the subthalamic nucleus improves mainly motor skills but also shows an important increase in sleep duration and quality, it could be suggested that by decreasing nocturnal hypokinesia improvement in sleep quality can be achieved.
Rasagiline mesylate was developed as a selective and irreversible MAO-B- inhibitor which is - unlike Selegiline - not metabolized to amphetamine derivates which are found to be partly responsible for negative effects on RBD and REM-sleep as well as sleep efficacy. Rasagiline is able to delay the need for initiating dopaminergic therapy, improves motor function in early and moderate to advanced PD and was shown to exhibit neuroprotective potential.
As different mechanisms of dopaminergic medication on different dopamine receptors are still not fully elucidated and in contrast to selegiline no side effects due to development of amphetamine derivates need to be taken into consideration, this study is to aim at evaluating the effects on sleep and daytime sleepiness of treatment with Rasagiline mesylate.
As 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 less sleep disruption in PD Patients than placebo it might be able to improve sleep architecture. Until now no clinical trial using polysomnographic techniques was performed to evaluate the effects of Rasagiline on sleep.
To 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. In addition, sleep quality and daytime sleepiness assessed by standardized scales as well as cognitive function, depression indices and QoL index are measured.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Dresden, Germany, 01307
- Dresden University of Technology, Dept. of Neurology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rasagiline
Effect of Rasagiline on sleep parameters in PD Patients
|
Rasagiline tablets 1mg once daily for 8 weeks
Other Names:
|
Placebo Comparator: Placebo
Effect of placebo on sleep parameters in PD Patients
|
Placebo 1tablet once daily for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sleep efficacy
Time Frame: baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
Change from baseline in sleep quality at 8 weeks
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in other sleep parameters
Time Frame: baseline and 8 weeks
|
Change from baseline in sleep parameters e.g.
portion of REM-sleep (%), portion of slow wave sleep (%), portion of light sleep (%), sleep latency (min), REM-sleep latency (min) in polysomnography at 8 weeks
|
baseline and 8 weeks
|
Electrocardiography
Time Frame: baseline and 8 weeks
|
Number of participants with adverse events
|
baseline and 8 weeks
|
Laboratory parameter
Time Frame: baseline and 8 weeks
|
Number of participants with adverse events
|
baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander Storch, MD, Dresden University of Technology, Dept. of Neurology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Sleep Wake Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Dyssomnias
- Parasomnias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Monoamine Oxidase Inhibitors
- Rasagiline
Other Study ID Numbers
- TUD-RaSPar-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinsons's Disease
-
Rennes University HospitalCompleted
-
Sleep Medicine Centre KempenhaegheTerminatedNocturnal Hypokinesia | Parkinsons's Disease | RotigotineNetherlands
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CelltrionRecruitingBowel Disease | Inflammatory Disease | Disease CrohnNetherlands
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Heart Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Arterial Occlusive DiseaseUnited States
-
Eye Hospital Pristina KosovoEnrolling by invitationProgressive Disease of CorneaeKosovo
-
Aveiro UniversityPrograma Operacional Inclusão Social e Emprego (POISE); Programa Operacional... and other collaboratorsCompletedLung Diseases | Chronic Obstructive Pulmonary Disease | Pulmonary Disease | Interstitial Lung Disease | Chronic Respiratory DiseasePortugal
-
McGill University Health Centre/Research Institute...CompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease ExacerbationCanada
Clinical Trials on Rasagiline
-
Teva Neuroscience, Inc.Completed
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedParkinson's DiseaseUnited States, Canada
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedParkinson's DiseaseUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedParkinson's Disease
-
Yunxia Wang, MDWestern ALS Study GroupCompletedAmyotrophic Lateral Sclerosis (ALS)United States, Canada
-
Teva Branded Pharmaceutical Products R&D, Inc.Completed
-
University of Maryland, BaltimoreStanley Medical Research InstituteCompletedSchizophreniaUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.H. Lundbeck A/S; Teva Neuroscience, Inc.CompletedParkinson's DiseaseUnited States, Argentina, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Portugal, Romania, Spain, United Kingdom
-
Teva Branded Pharmaceutical Products R&D, Inc.Completed
-
Istanbul UniversityUnknownParkinson's DiseaseTurkey