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Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (Ras-PDS-1)

This study has been terminated.
(payments stopped by grant provider)
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: August 6, 2010
Last updated: October 3, 2012
Last verified: October 2012

Sleep-wake disturbances (SWD) are frequent in Parkinson's disease (PD) and affect the quality of life of affected patients.

Rasagiline is a potent, highly selective, irreversible, second-generation, monoamine oxidase type-B (MAO-B) inhibitor with a 24h dopaminergic effect.

It is well known that dopaminergic treatment closely interacts with SWD. This study aims to assess the effect of Rasagiline on SWD in PD patients. In this randomized, double-blind, placebo controlled study in clinical phase IV, 60 subjects will be treated with rasagiline 1mg po once daily or placebo over 8 weeks. The study is planned to be conducted in 6-9 Swiss centers. Questionaires will be used to assess SWDs: sleep disturbances (Parkinson's Disease Sleep Scale, PDSS), daytime sleepiness (Epworth Sleepiness Scale, ESS), fatigue (Fatigue Severity Scale, FSS), apathy (Apathy Evaluation Scale Self, AES-S), disability (Sheehan scale) and QoL in PD patients.

  • Trial with medicinal product

Condition Intervention Phase
Parkinson's Disease
Drug: Rasagiline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD)

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS) [ Time Frame: Baseline after 8 weeks of treatment ]
    Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)

Enrollment: 1
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rasagiline Drug: Rasagiline
Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily
Placebo Comparator: Placebo Drug: Rasagiline
Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Probable diagnosis of Parkinson's disease according to the modified UK Parkinson's Disease Society Brain Bank criteria
  2. Hoehn and Yahr up to stage 3 in the off-state
  3. Age = 40 years
  4. On the basis of a physical examination and medical history, the patient is in the investigator's opinion otherwise healthy
  5. Parkinson's Disease Sleep Scale (PDSS) score = 90.
  6. Patients with stable dosage of hypnotics / sedative /neuropsychiatric treatment including antiParkinsonian treatment in the last 4 weeks before screening evaluation and with no change foreseen during the study period. Dose adjustments can be made, but no change or discontinuation of drugs.
  7. Subjects must understand questionnaires in German, French or Italian
  8. Provided signed informed consent
  9. Females of childbearing potential must agree to utilize highly effective contraceptive methods of birth control.
  10. Females of child bearing potential must have a negative pregnancy test.

Exclusion criteria:

  1. Diagnosis unclear or suspicion of another than Parkinson's disease
  2. Patients with cognitive deficit (MMSE < 26)
  3. Patients who have undergone surgery for the treatment of PD
  4. Patients with non-response to adequate antiParkinsonian treatment
  5. History of moderate to severe hepatic insufficiency.
  6. Clinically relevant or unstable vascular disease
  7. History of drug or alcohol abuse (within the past 10 years)
  8. Patients with a history of psychotic disorders
  9. Patients with treatment resistant/recurrent major depression (HADS =19)
  10. Patients with unstable dosage of antiParkinsonian or neuropsychiatric treatment in the last 4 weeks before screening evaluation.
  11. Concomitant use of fluoxetine, fluvoxamine, pethidine or monoamine oxidase inhibitors (MAOI) during the course of the study and within 3 months prior to screening evaluation. Patient may be rescreened 3 months after discontinuation of the above mentioned drugs.
  12. Concomitant use of dextromethorphan, ephedrine or pseudoephedrine during the course of the study
  13. Women who are pregnant or lactating
  14. Participation in another study during or up to 30 days prior to participation in this study
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Please refer to this study by its identifier: NCT01178047

University Hospital, Neurology
Zurich, ZH, Switzerland, CH-8091
Neurocentro, Lugano
Lugano, Switzerland
Sponsors and Collaborators
University of Zurich
H. Lundbeck A/S
Principal Investigator: Christian Baumann, Assoc Prof, MD University Hospital Zurich, Neurology
  More Information

Responsible Party: University of Zurich Identifier: NCT01178047     History of Changes
Other Study ID Numbers: Ras-PDS-1
Study First Received: August 6, 2010
Last Updated: October 3, 2012

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on May 24, 2017