Restless Legs SyndromePhase 2/3RAS-RLSNCT01192503
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
A Phase 2/3 study testing rasagiline in people with Restless Legs Syndrome, run by University of Virginia at 8 sites in United States.
Trial summary
The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- 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
- 52 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2010to Aug 2012
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women at least 18 years of age, capable of providing informed consent
- Diagnosed with idiopathic RLS, defined as meeting the International RLS Study Group diagnostic criteria without evidence for secondary causes of RLS
- Moderate or severe symptoms, defined as a score of 15 or greater on the International RLS Study Group Rating Scale (IRLS)
- Not currently receiving treatment for RLS. A 30-day washout period will be required for participants on dopamine agonists or other therapies. Stable doses of iron supplementation will be allowed
- On a stable dose of the following antidepressants, for at least 30 days prior to baseline visit:
- Amitriptyline, up to 50mg/day
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- Trazodone, up to 100mg/day
- Citalopram, up to 20mg/day
- Escitalopram, up to 10mg/day
- Paroxetine, up to 30mg/day
- Sertraline, up to 100mg/day
- Female subjects must not be of childbearing potential or must agree to use of contraception for duration of study
Who cannot join
- Signs consistent with a secondary cause of RLS:
- History of initial unresponsiveness to dopaminergic RLS treatment despite adequate dose of initial therapy
- Use of another MAO inhibitor within 30 days of baseline visit
- Allergy or adverse reaction to rasagiline
- Prior adverse reaction to tyramine-containing foods
- Use of meperidine or other opiates within 30 days of the baseline visit
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- Use of benzodiazepines within 30 days of the baseline visit
- Use of antidepressants, including TCAs, SSRIs, and SNRIs, except for those permitted as listed above
- Use of other drugs or supplements contraindicated with rasagiline, including St. John's wort, mirtazapine, cyclobenzaprine, dextromethorphan, cold products that contain ephedrine, pseudoephedrine
- Scheduled to undergo elective surgery during the course of the study
- Active medical or psychiatric illness that requires changes to treatment during the course of the study or jeopardize the subject's ability to remain in the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Medical College of Georgia Movements Disorders Program
Augusta, Georgia, 30912
SUNY- Buffalo Jacobs Neurological Institute
Buffalo, New York, 14203
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, 60611
Cleveland Clinic Sleep Disorders Center
Cleveland, Ohio, 44195
University of Pennsylvania Sleep Center
Philadelphia, Pennsylvania, 19104
Advent Research
Pinellas Park, Florida, 33781
Atlantic Neuroscience Institute Overlook Hospital
Summit, New Jersey, 07902
About this study
The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS.
Read the detailed description
The primary objective is to determine if rasagiline, at a dosage of 1mg/day, is non-futile for the treatment of RLS, as measured by the International RLS Study Group Rating Scale (IRLS). The primary outcome variable will be the change in IRLS from baseline to Week 12.
The secondary objectives are to determine if rasagiline, at a dosage of 1mg/day, is safe and well-tolerated in participants with RLS. Also, to determine if rasagiline improves measures of global clinical change, sleep quality, excessive sleepiness, quality of life, or depressive symptoms.
- Conditions
- Restless Legs Syndrome
- Being tested
- rasagiline, placebo (sugar pill)
- Keywords
- Restless Legs Syndrome, rasagiline, futility
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rasagilineDrug
Also called Azilect
1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
placebo (sugar pill)Drug
1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| rasagiline | Active comparator | Not described Receives: Drug: rasagiline |
| placebo (sugar pill) | Placebo comparator | Not described Receives: Drug: placebo (sugar pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
The IRLS is a 10-question scale that contains questions about both the frequency and severity of RLS symptoms, as well as secondary aspects such as sleep quality and daytime tiredness.
Measured: Screening, Baseline, Week 6, Week 12
Secondary outcomes (7)
Tolerability (ability to complete study on assigned dosage)
Measured: 12 weeks
Adverse events
Measured: 12 weeks
Change in Beck Depression Inventory from Baseline to Week 12
Measured: Baseline, Week 6, Week 12
Change in Clinical Global Impression - Change from Baseline to Weeks 12
Measured: Baseline, Week 6, Week 12
Change in Medical Outcome Study Sleep Scale from Baseline to Week 12
Measured: Baseline, Week 6, Week 12
Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12
Measured: Baseline, week 6, Week 12
Change in Epworth Sleepiness Scale from Baseline to Week 12
Measured: Baseline, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionAug 2012
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Neuroscience, Inc.
- Responsible party
- Principal investigator, Colleen P Harman, University of Virginia
- Investigators
- Tiffini S Voss, MD, Principal investigator, University of Virginia, Department of NeurologyBernad Ravina, MD. MSCE, Principal investigator, University of Rochester, Movement and Inherited Neurological Disorders Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192503
- Sponsor's protocol ID
- 14630
- Acronym
- RAS-RLS
- Status last verified
- Feb 2013
- First submitted
- 23 Aug 2010
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Rasagiline in Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT01192503
- Acronym / sponsor ID
- RAS-RLS / 14630
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, rasagiline, futility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Teva Neuroscience, Inc.
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Sep 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.
The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS.
Detailed description
The primary objective is to determine if rasagiline, at a dosage of 1mg/day, is non-futile for the treatment of RLS, as measured by the International RLS Study Group Rating Scale (IRLS). The primary outcome variable will be the change in IRLS from baseline to Week 12.
The secondary objectives are to determine if rasagiline, at a dosage of 1mg/day, is safe and well-tolerated in participants with RLS. Also, to determine if rasagiline improves measures of global clinical change, sleep quality, excessive sleepiness, quality of life, or depressive symptoms.
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 (sugar pill) | Placebo comparator | Drug: placebo (sugar pill) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women at least 18 years of age, capable of providing informed consent
- Diagnosed with idiopathic RLS, defined as meeting the International RLS Study Group diagnostic criteria without evidence for secondary causes of RLS
- Moderate or severe symptoms, defined as a score of 15 or greater on the International RLS Study Group Rating Scale (IRLS)
- Not currently receiving treatment for RLS. A 30-day washout period will be required for participants on dopamine agonists or other therapies. Stable doses of iron supplementation will be allowed
- On a stable dose of the following antidepressants, for at least 30 days prior to baseline visit:
Key exclusion criteria (11 listed)
- Signs consistent with a secondary cause of RLS:
- History of initial unresponsiveness to dopaminergic RLS treatment despite adequate dose of initial therapy
- Use of another MAO inhibitor within 30 days of baseline visit
- Allergy or adverse reaction to rasagiline
- Prior adverse reaction to tyramine-containing foods
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 |
|---|---|---|
| rasagilineAlso: Azilect1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks | Drug | rasagiline |
| placebo (sugar pill)1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks | Drug | placebo (sugar pill) |
Primary outcome
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
Time frame: Screening, Baseline, Week 6, Week 12
The IRLS is a 10-question scale that contains questions about both the frequency and severity of RLS symptoms, as well as secondary aspects such as sleep quality and daytime tiredness.
7 secondary outcomes
Tolerability (ability to complete study on assigned dosage)
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Change in Beck Depression Inventory from Baseline to Week 12
Time frame: Baseline, Week 6, Week 12
Change in Clinical Global Impression - Change from Baseline to Weeks 12
Time frame: Baseline, Week 6, Week 12
Change in Medical Outcome Study Sleep Scale from Baseline to Week 12
Time frame: Baseline, Week 6, Week 12
Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12
Time frame: Baseline, week 6, Week 12
Change in Epworth Sleepiness Scale from Baseline to Week 12
Time frame: Baseline, Week 6, Week 12
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 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.
Tiffini S Voss, MD principal investigator
University of Virginia, Department of Neurology
Bernad Ravina, MD. MSCE principal investigator
University of Rochester, Movement and Inherited Neurological Disorders Unit
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rasagiline in people with Restless Legs Syndrome, run by University of Virginia at 8 sites in United States.
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 12 inclusion and 11 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Slow enrollment). 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?
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12 (time frame: Screening, Baseline, Week 6, Week 12). 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 11 Feb 2013.