Restless Legs SyndromePhase 4NCT00200941
Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome
A Phase 4 study testing Topiramate in people with Restless Legs Syndrome, run by Neurocare at 1 site in United States.
Trial summary
This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Topiramate
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Apr 2005
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The symptoms of each subject must meet the diagnostic criteria of the International RLS Study Group
- More than five periodic leg movements per hour recorded during baseline polysomnography (PSG)
- Each subject must discontinue all treatments for RLS and agreed not to take other RLS treatments during the study
Who cannot join
- Clinically unstable medical problems
- History of nephrolithiasis
- Progressive neurologic disease
- Inadequate therapeutic response from two previous treatment regimens for RLS
- Subjects unable to discontinue medications known to cause or suppress RLS
- Subjects with sleep apnea syndrome
- Subjects consuming daily more than three beverages containing caffeine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effacy and Safety of Topiramate in Subjects With Restless Legs Syndrome (RLS)
This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.
Read the detailed description
Benzodiazepines, levo-dopa/carbidopa, dopamine agonists, anticonvulsants, and opioids have been used with variable success, to treat RLS. Often, RLS patients treated with a benzodiazepine, over the course of several months, develop tolerance to the medication. Also, benzodiazepines can cause confusion or daytime sleepiness and may be addictive. Patients may also develop tolerance to levo-dopa/carbidopa treatment. Because of the short half-life, symptoms may be suppressed for only the first part of the sleep period and then recur later during the night. Rebound has been reported. Worse yet, augmentation, the occurrence of RLS symptoms, often more severe than before treatment began, earlier in the day, may occur in up to 80% of RLS patients treated with levod-dopa/carbidopa. Dopamine agonists, including pergolide, pramipexole, and ropinirole, are effective for some patients but not for others. Common side effects of these drugs include coryza, hypotension, and rash. Of the anticonvulsants, preliminary reports suggest that gabapentin, carbamazepine, and divalproex can suppress RLS symptoms in some patients, especially those with mild RLS. Side effects include sleepiness, ataxia, and weight gain. Opioid treatment for RLS has been described as effective but, aside from the stigma of taking controlled substances regularly, side effects may include nausea, sedation, constipation, and dysequilibrium. Iron supplementation is therapeutic in some patients with iron deficiency and RLS.
Preliminary anecdotal data suggest that topiramate reduces RLS symptoms. Topiramate has several potential mechanisms of action including enhancement of GABA-mediated inhibition, which may account for the observed benefit in patients with RLS.
Topiramate may be a better alternative than the currently available treatments to suppress RLS symptoms. Like gabapentin, it offers the possibility of decreasing RLS symptoms while also diminishing pain, especially in those patients who have limb pain from neuropathy, radiculopathy, or other causes. Unlike gabapentin, topiramate may help overweight patients with RLS lose weight, if anedotal reports on weight reduction with the medication are correct.
- Conditions
- Restless Legs Syndrome
- Being tested
- Topiramate
- Keywords
- Restless Legs Syndrome, Topiramate, Actigraphy, Polysomnography
- 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.
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The average number of periodic leg movements during three consecutive nights of actigraphy beginning at the end of the double blind phase
Secondary outcomes (7)
Proportion of time in bed without leg movements during the three consecutive nights of actigraphy beginning at the end of the double blind phase
SF-36 at the last visit of the double blind phase
Score on the RLS Rating Scale (modified) questionnaire at the last visit of the double blind phase
Periodic leg movements during sleep and wakefulness during the PSG recorded at the end of the double blind phase
PSG measures including periodic leg movement arousal index, latency until sustained sleep, sleep efficacy, and wake after sleep onset
Sleep diaries at the last double-blind visit
Epworth sleepiness scale at the last double-blind visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2001
- Study completionApr 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 4
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- Neurocare
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Pharmaceutical
- Investigators
- Michael P Biber, MD, Principal investigator, Neurocare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200941
- Sponsor's protocol ID
- CAPSS-178
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 16 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effacy and Safety of Topiramate in Subjects With Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT00200941
- Acronym / sponsor ID
- CAPSS-178
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Topiramate, Actigraphy, Polysomnography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- NeurocareUniversity, hospital or other
- Collaborators
- Ortho-McNeil Pharmaceutical
- Study start
- Aug 2001
- Study completion
- Apr 2005
- First posted
- 20 Sep 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.
This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.
Detailed description
Benzodiazepines, levo-dopa/carbidopa, dopamine agonists, anticonvulsants, and opioids have been used with variable success, to treat RLS. Often, RLS patients treated with a benzodiazepine, over the course of several months, develop tolerance to the medication. Also, benzodiazepines can cause confusion or daytime sleepiness and may be addictive. Patients may also develop tolerance to levo-dopa/carbidopa treatment. Because of the short half-life, symptoms may be suppressed for only the first part of the sleep period and then recur later during the night. Rebound has been reported. Worse yet, augmentation, the occurrence of RLS symptoms, often more severe than before treatment began, earlier in the day, may occur in up to 80% of RLS patients treated with levod-dopa/carbidopa. Dopamine agonists, including pergolide, pramipexole, and ropinirole, are effective for some patients but not for others. Common side effects of these drugs include coryza, hypotension, and rash. Of the anticonvulsants, preliminary reports suggest that gabapentin, carbamazepine, and divalproex can suppress RLS symptoms in some patients, especially those with mild RLS. Side effects include sleepiness, ataxia, and weight gain. Opioid treatment for RLS has been described as effective but, aside from the stigma of taking controlled substances regularly, side effects may include nausea, sedation, constipation, and dysequilibrium. Iron supplementation is therapeutic in some patients with iron deficiency and RLS.
Preliminary anecdotal data suggest that topiramate reduces RLS symptoms. Topiramate has several potential mechanisms of action including enhancement of GABA-mediated inhibition, which may account for the observed benefit in patients with RLS.
Topiramate may be a better alternative than the currently available treatments to suppress RLS symptoms. Like gabapentin, it offers the possibility of decreasing RLS symptoms while also diminishing pain, especially in those patients who have limb pain from neuropathy, radiculopathy, or other causes. Unlike gabapentin, topiramate may help overweight patients with RLS lose weight, if anedotal reports on weight reduction with the medication are correct.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The symptoms of each subject must meet the diagnostic criteria of the International RLS Study Group
- More than five periodic leg movements per hour recorded during baseline polysomnography (PSG)
- Each subject must discontinue all treatments for RLS and agreed not to take other RLS treatments during the study
Key exclusion criteria (7 listed)
- Clinically unstable medical problems
- History of nephrolithiasis
- Progressive neurologic disease
- Inadequate therapeutic response from two previous treatment regimens for RLS
- Subjects unable to discontinue medications known to cause or suppress RLS
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 |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
The average number of periodic leg movements during three consecutive nights of actigraphy beginning at the end of the double blind phase
7 secondary outcomes
Proportion of time in bed without leg movements during the three consecutive nights of actigraphy beginning at the end of the double blind phase
SF-36 at the last visit of the double blind phase
Score on the RLS Rating Scale (modified) questionnaire at the last visit of the double blind phase
Periodic leg movements during sleep and wakefulness during the PSG recorded at the end of the double blind phase
PSG measures including periodic leg movement arousal index, latency until sustained sleep, sleep efficacy, and wake after sleep onset
Sleep diaries at the last double-blind visit
Epworth sleepiness scale at the last double-blind visit
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 16 Dec 2005.
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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.
Michael P Biber, MD principal investigator
Neurocare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Restless Legs Syndrome, run by Neurocare 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 3 inclusion and 7 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 16 Dec 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 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 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?
The average number of periodic leg movements during three consecutive nights of actigraphy beginning at the end of the double blind phase. 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 16 Dec 2005.