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)
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01178047
First received: August 6, 2010
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178047

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

No publications provided

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
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 September 18, 2014