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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01178047
• Date of registration: 06/08/2010
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease Ras-PDS-1
• Scientific 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)
• Date of first enrolment: September 2011
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01178047
• 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
• Phase: Phase 4

Countries of recruitment

Switzerland

Contacts

• Name: Christian Baumann, Assoc Prof, MD
• Affiliation: University Hospital Zurich, Neurology

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Rasagiline

Primary Outcome(s)

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

Secondary ID(s)

Ras-PDS-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

H. Lundbeck A/S