Parkinson's DiseasePhase 4Ras-PDS-1NCT01178047
Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease
A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by University of Zurich at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rasagiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Sep 2011to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Neurocentro, Lugano
Lugano, Lugano
University Hospital, Neurology
Zurich, Canton of Zurich, CH-8091
About this study
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)
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.
Read more
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
- Conditions
- Parkinson's Disease
- Being tested
- Rasagiline
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasagilineDrug
Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline | Active comparator | Not described Receives: Drug: Rasagiline |
| Placebo | Placebo comparator | Not described Receives: Drug: Rasagiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: payments stopped by grant provider
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
- Investigators
- Christian Baumann, Assoc Prof, MD, Principal investigator, University Hospital Zurich, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178047
- Sponsor's protocol ID
- Ras-PDS-1
- Acronym
- Ras-PDS-1
- Status last verified
- Oct 2012
- First submitted
- 6 Aug 2010
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01178047
- Acronym / sponsor ID
- Ras-PDS-1 / Ras-PDS-1
- Conditions
- Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: payments stopped by grant provider
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline | Active comparator | Drug: Rasagiline |
| Placebo | Placebo comparator | Drug: Rasagiline |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RasagilineRasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily | Drug | Placebo, Rasagiline |
Primary outcome
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)
Time frame: Baseline after 8 weeks of treatment
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS)
Results and safety
The study was stopped early (reason given: payments stopped by grant provider). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Baumann, Assoc Prof, MD principal investigator
University Hospital Zurich, Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: payments stopped by grant provider). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of rasagiline on sleep disturbances in PD patients: Parkinson's Disease Sleep Scale (PDSS) (time frame: Baseline after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.