Back to resultsMulticenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (Ras-PDS-1)
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Rasagiline
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
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
Sites / Locations
- University Hospital, Neurology
- Neurocentro, Lugano
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rasagiline
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01178047
First Posted
August 6, 2010
Last Updated
October 3, 2012
Sponsor
University of Zurich
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT01178047
Brief Title
Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
payments stopped by grant provider
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rasagiline
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rasagiline
Intervention Description
Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily
Primary Outcome Measure Information:
Title
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)
Description
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)
Time Frame
Baseline after 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Baumann, Assoc Prof, MD
Organizational Affiliation
University Hospital Zurich, Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Neurology
City
Zurich
State/Province
ZH
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Neurocentro, Lugano
City
Lugano
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease
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