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

Parkinson's Disease Clinical Trial

— Ras-PDS-1  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01178047
• Other study ID #: Ras-PDS-1
• Status: Terminated
• Phase: Phase 4
• First received: August 6, 2010
• Last updated: October 3, 2012
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline
Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily

Locations

Country	Name	City	State
Switzerland	Neurocentro, Lugano	Lugano
Switzerland	University Hospital, Neurology	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	H. Lundbeck A/S

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes