Status:
TERMINATED
Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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, ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Probable diagnosis of Parkinson's disease according to the modified UK Parkinson's Disease Society Brain Bank criteria
- Hoehn and Yahr up to stage 3 in the off-state
- Age = 40 years
- On the basis of a physical examination and medical history, the patient is in the investigator's opinion otherwise healthy
- Parkinson's Disease Sleep Scale (PDSS) score = 90.
- 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.
- Subjects must understand questionnaires in German, French or Italian
- Provided signed informed consent
- Females of childbearing potential must agree to utilize highly effective contraceptive methods of birth control.
- Females of child bearing potential must have a negative pregnancy test.
- Exclusion criteria:
- Diagnosis unclear or suspicion of another than Parkinson's disease
- Patients with cognitive deficit (MMSE \< 26)
- Patients who have undergone surgery for the treatment of PD
- Patients with non-response to adequate antiParkinsonian treatment
- History of moderate to severe hepatic insufficiency.
- Clinically relevant or unstable vascular disease
- History of drug or alcohol abuse (within the past 10 years)
- Patients with a history of psychotic disorders
- Patients with treatment resistant/recurrent major depression (HADS =19)
- Patients with unstable dosage of antiParkinsonian or neuropsychiatric treatment in the last 4 weeks before screening evaluation.
- 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.
- Concomitant use of dextromethorphan, ephedrine or pseudoephedrine during the course of the study
- Women who are pregnant or lactating
- Participation in another study during or up to 30 days prior to participation in this study
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01178047
Start Date
September 1 2011
End Date
October 1 2012
Last Update
October 4 2012
Active Locations (2)
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1
University Hospital, Neurology
Zurich, Canton of Zurich, Switzerland, CH-8091
2
Neurocentro, Lugano
Lugano, Lugano, Switzerland