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

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)

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

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Rasagiline

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Lugano, Switzerland
    • Neurocentro, Lugano
  • ZH
    • Zurich, ZH, Switzerland, CH-8091
      • University Hospital, neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Rasagiline; Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily
ACTIVE_COMPARATOR: Rasagiline	Drug: Rasagiline; Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)	Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)	Baseline after 8 weeks of treatment

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: H. Lundbeck A/S
• Investigators: Principal Investigator: Christian Baumann, Assoc Prof, MD, University Hospital Zurich, Neurology

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: August 6, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (ESTIMATE): August 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 4, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: Ras-PDS-1