Parkinson's DiseasePDNCT01032486
Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease
An observational study of Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rasagiline mesylate
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jul 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a sample of participants with Parkinson's disease who will be prescribed Azilect® treatment as per Canadian product monograph in order to observe changes in sleep behaviour.
Who may be able to join
- idiopathic Parkinson's disease.
- eligible to Azilect® treatment as per Canadian product monograph
Who cannot join
- exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the Canadian product monograph.
- investigational drug within 30 days prior to study
- use of Azilect® or selegiline within 60 days prior to study
- significant medical condition
About this study
Official title: An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects
The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.
- Conditions
- Parkinson's Disease
- Being tested
- Rasagiline mesylate
- Keywords
- Rasagiline, Sleep, Sleepiness, Parkinson's Disease Sleep Scale, Epworth Sleepiness Scale
- Medical subject headings
- Parkinson Disease, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rasagiline mesylateDrug
Also called Rasagiline mesylate, Azilect
Azilect® tablets (0.5mg or 1.0 mg) administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Azilect | Subjects with a diagnosis of idiopathic Parkinson's disease eligible to Azilect® treatment based on the investigator's clinical assessment and according to the Canadian product monograph. Receives: Drug: Rasagiline mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).
Measured: 2 months
Secondary outcomes (1)
Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionJul 2011
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Panisset, MD, Principal investigator, André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032486
- Sponsor's protocol ID
- TNC-RAS-PD/01
- Other IDs
- REST
- Acronym
- PD
- Status last verified
- Aug 2013
- First submitted
- 11 Dec 2009
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects
- ClinicalTrials.gov ID
- NCT01032486
- Acronym / sponsor ID
- PD / TNC-RAS-PD/01
- Conditions
- Parkinson's Disease
- Keywords
- Rasagiline, Sleep, Sleepiness, Parkinson's Disease Sleep Scale, Epworth Sleepiness Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Dec 2009 (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.
The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azilect | – | Drug: Rasagiline mesylateSubjects with a diagnosis of idiopathic Parkinson's disease eligible to Azilect® treatment based on the investigator's clinical assessment and according to the Canadian product monograph. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a sample of participants with Parkinson's disease who will be prescribed Azilect® treatment as per Canadian product monograph in order to observe changes in sleep behaviour.
Key inclusion criteria (2 listed)
- idiopathic Parkinson's disease.
- eligible to Azilect® treatment as per Canadian product monograph
Key exclusion criteria (4 listed)
- exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the Canadian product monograph.
- investigational drug within 30 days prior to study
- use of Azilect® or selegiline within 60 days prior to study
- significant medical condition
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 |
|---|---|---|
| Rasagiline mesylateAlso: Rasagiline mesylate, AzilectAzilect® tablets (0.5mg or 1.0 mg) administered orally once daily | Drug | Azilect |
Primary outcome
Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).
Time frame: 2 months
1 secondary outcome
Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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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.
Michel Panisset, MD principal investigator
André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS). (time frame: 2 months). 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 28 Aug 2013.