Trial record 10 of 1789 for:    Parasomnias

Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease (RaSPar)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Technische Universität Dresden.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01442610
First received: September 23, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Sleep Disturbances
Parkinsons's Disease
Drug: Rasagiline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Rasagiline on Sleep Disturbances in PD: A Single Center, Randomized, Double-blind, Placebo run-in, Polysomnographic Clinical Phase IV Trial

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Change in sleep efficacy [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in sleep efficacy (% in time in bed (TIB) / sleep partial time (SPT)) in polysomnography at 8 weeks

  • Change in PDSS-2 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in sleep quality at 8 weeks


Secondary Outcome Measures:
  • Change in other sleep parameters [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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

  • Electrocardiography [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Laboratory parameter [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasagiline
Effect of Rasagiline on sleep parameters in PD Patients
Drug: Rasagiline
Rasagiline tablets 1mg once daily for 8 weeks
Other Name: Azilect
Placebo Comparator: Placebo
Effect of placebo on sleep parameters in PD Patients
Drug: Placebo
Placebo 1tablet once daily for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442610

Contacts
Contact: Wiebke Schrempf, MD ++49-351-458 ext 2532 wiebke.schrempf@neuro.med.tu-dresden.de
Contact: Christiana Ossig, MD ++49-351-458 ext 2532 christiana.ossig@uniklinikum-dresden.de

Locations
Germany
Dresden University of Technology, Dept. of Neurology Not yet recruiting
Dresden, Germany, 01307
Contact: Wiebke Schrempf, MD    ++49-351-458 ext 2532    wiebke.schrempf@uniklinikum-dresden.de   
Contact: Christiana Ossig, MD    ++49-351-458 ext 2532    christiana.ossig@uniklinikum-dresden.de   
Principal Investigator: Wiebke Schrempf, MD         
Dresden University of Technology, Dept. of Neurology Not yet recruiting
Dresden, Germany, 01307
Contact: Wiebke Schrempf, MD    +49-351-458 ext 2532      
Principal Investigator: Wiebke Schrempf, MD         
Sub-Investigator: Christiana Ossig, MD         
Sub-Investigator: Mareike Fauser, MD         
Sub-Investigator: Antonia Maaß, MD         
Sub-Investigator: Sebastian Brown, MD         
Sub-Investigator: Moritz Brandt, MD         
Sub-Investigator: Lisa Klingelhoefer, MD         
Sponsors and Collaborators
Technische Universität Dresden
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Alexander Storch, MD Dresden University of Technology, Dept. of Neurology
  More Information

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01442610     History of Changes
Other Study ID Numbers: TUD-RaSPar-051
Study First Received: September 23, 2011
Last Updated: September 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Rasagiline
Sleep disorder
Parkinson's disease
Sleep Disturbances in patients with parkinsons's disease

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Parkinson Disease
Dyssomnias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014