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

• Sponsor: University of Zurich (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01178047
• Collaborator: H. Lundbeck A/S (Industry)
• Enrollment: 1
• Locations: 2
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Rasagiline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (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)
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

   Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital, Neurology	Zurich	ZH	Switzerland	CH-8091
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01178047
• Other Study ID Numbers: Ras-PDS-1
• First Posted: Aug 9, 2010
• Last Update Posted: Oct 4, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Parkinson Disease; Rasagiline

Study Results

No Results Posted as of Oct 4, 2012