Restless Legs SyndromePhase 2NCT00247364
A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)
A Phase 2 study testing Levetiracetam (Keppra) in people with Restless Legs Syndrome, run by Sleep Health Centers at 1 site in United States.
Trial summary
To define the effective dose and tolerability of levetiracetam in individuals with Restless Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of RLS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Levetiracetam (Keppra)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Oct 2005
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
- The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as sitting or lying down.
- The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
- The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
- IRLS Rating Scale score greater than 15 at Baseline visit PLM-Index of 5 or greater during the first night of polysomnography Written informed consent obtained prior to any study procedures being performed.
Who cannot join
- Women of childbearing potential, who have a positive urine pregnancy test or are lactating as the screening visit, or do not practice a clinically accepted method of contraception.
- Individuals who are taking medication for Restless Legs Syndrome without a proper washout period
- Individuals who are taking hypnotics, sedatives, antipsychotics, or neuroleptics
- History of current diagnosis of other clinically relevant diseases that may confound assessments of RLS symptoms (e.g., Parkinson's disease, dementia, ALS, etc.)
- Subjects with serum ferritin below 10µg/L
- Subjects with an untreated sleep disorder that may confound assessments (e.g., narcolepsy, sleep apnea syndrome or other breathing-related sleep disorders, or REM sleep behaviour disorder)
Show all 11Show fewer
- Subjects with an apnea/hypopnea index of 15 or greater at the initial polysomnography visit
- Subjects employed in shift work (e.g., employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts)
- Subjects who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the subject unsuitable for the study (e.g. severe cardiovascular disease, major depression, psychosis, hepatic or renal failure, etc.)
- subjects with a positive urine drug test for illicit use of amphetamines, barbiturates, benzodiazepines, opiates, synthetic narcotics, and miscellaneous drugs commonly known as recreational drugs (e.g., cannabinoids including THC, heroine, cocaine)
- Participation in any clinical drug or device trial in the 30 days prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
To define the effective dose and tolerability of levetiracetam in individuals with Restless Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of RLS.
- Conditions
- Restless Legs Syndrome
- Being tested
- Levetiracetam (Keppra)
- Keywords
- RLS
- 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.
Levetiracetam (Keppra)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
1:To investigate the efficacy of levetiracetam when used to treat RLS.
2:To assess tolerability and adverse event rates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startNov 2003
- Study completionOct 2005
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Sleep Health Centers
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- John W Winkelman, MD, PhD, Principal investigator, Sleep Health Centers, Brigham and Women's Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247364
- Sponsor's protocol ID
- 2003-P-001804
- Status last verified
- Oct 2005
- First submitted
- 28 Oct 2005
- Last updated
- 1 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT00247364
- Acronym / sponsor ID
- 2003-P-001804
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Sleep Health CentersUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Nov 2003
- Study completion
- Oct 2005
- First posted
- 1 Nov 2005 (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.
To define the effective dose and tolerability of levetiracetam in individuals with Restless Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of RLS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria
- IRLS Rating Scale score greater than 15 at Baseline visit PLM-Index of 5 or greater during the first night of polysomnography Written informed consent obtained prior to any study procedures being performed.
Key exclusion criteria (11 listed)
- Women of childbearing potential, who have a positive urine pregnancy test or are lactating as the screening visit, or do not practice a clinically accepted method of contraception.
- Individuals who are taking medication for Restless Legs Syndrome without a proper washout period
- Individuals who are taking hypnotics, sedatives, antipsychotics, or neuroleptics
- History of current diagnosis of other clinically relevant diseases that may confound assessments of RLS symptoms (e.g., Parkinson's disease, dementia, ALS, etc.)
- Subjects with serum ferritin below 10µg/L
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 |
|---|---|---|
| Levetiracetam (Keppra) | Drug | – |
Primary outcome
1:To investigate the efficacy of levetiracetam when used to treat RLS.
2:To assess tolerability and adverse event rates.
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 1 Nov 2005.
Related trials for Restless Legs Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
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.
John W Winkelman, MD, PhD principal investigator
Sleep Health Centers, Brigham and Women's Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam (Keppra) in people with Restless Legs Syndrome, run by Sleep Health Centers at 1 site 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 6 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: finished, as of the sponsor's last update on 1 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
1:To investigate the efficacy of levetiracetam when used to treat RLS.. The study lists 2 primary outcomes in all. 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 1 Nov 2005.