Restless Legs SyndromePhase 3NCT00298623
XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.
A Phase 3 study testing XP13512 (GSK1838262) in people with Restless Legs Syndrome, run by XenoPort, Inc..
Trial summary
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (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?
- XP13512 (GSK1838262)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Feb 2007
- Phase
- Phase 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
- Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
- History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
- Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Baseline study period;
- Total RLS severity score of 15 or greater on the International Restless Legs Syndrome Study Group Rating Scale (IRLS rating scale) at Visit 1 and at Visit 2;
- Discontinuation of dopamine agonists and/or gabapentin at least 2 weeks prior to Baseline;
- Discontinuation of other treatments for RLS (e.g., opioids, benzodiazepines) at least 2 weeks prior to Baseline;
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- If female of child-bearing potential, the subject must agree to use clinically accepted birth control through completion of the study;
- Body Mass Index of 34 or below;
- Estimated creatinine clearance of at least 60 mL/min;
Who cannot join
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
- Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
- Pregnant or lactating women;
- Women of childbearing potential who are not practicing an acceptable method of birth control.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
- Conditions
- Restless Legs Syndrome
- Being tested
- XP13512 (GSK1838262), placebo
- 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.
XP13512 (GSK1838262)Drug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
| XP13512 (GSK1838262) | Experimental | Not described Receives: Drug: XP13512 (GSK1838262) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.
Measured: 12-week treatment period
The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement
Measured: 12-week treatment period
Secondary outcomes (1)
Onset of efficacy. Subjective measures of sleep.
Measured: 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298623
- Sponsor's protocol ID
- 110963
- Status last verified
- May 2011
- First submitted
- 28 Feb 2006
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kushida CA, Walters AS, Becker P, Thein SG, Perkins AT, Roth T, Canafax D, Barrett RW; XP021 Study Group. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep. 2009 Feb;32(2):159-68. doi: 10.1093/sleep/32.2.159.
PubMed 19238802Ahmed M, Hays R, Steven Poceta J, Jaros MJ, Kim R, Shang G. Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials. Clin Ther. 2016 Jul;38(7):1726-1737.e1. doi: 10.1016/j.clinthera.2016.05.008. Epub 2016 Jun 7.
PubMed 27288210Avidan AY, Lee D, Park M, Jaros MJ, Shang G, Kim R. The Effect of Gabapentin Enacarbil on Quality of Life and Mood Outcomes in a Pooled Population of Adult Patients with Moderate-to-Severe Primary Restless Legs Syndrome. CNS Drugs. 2016 Apr;30(4):305-16. doi: 10.1007/s40263-016-0329-4.
PubMed 27067343Ondo WG, Hermanowicz N, Borreguero DG, Jaros MJ, Kim R, Shang G. Effect of prior exposure to dopamine agonists on treatment with gabapentin enacarbil in adults with moderate-to-severe primary restless legs syndrome: pooled analyses from 3 randomized trials. J Clin Mov Disord. 2015 Mar 30;2:9. doi: 10.1186/s40734-015-0018-3. eCollection 2015.
PubMed 26788345Canafax DM, Bhanegaonkar A, Bharmal M, Calloway M. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials. BMC Neurol. 2011 Apr 28;11:48. doi: 10.1186/1471-2377-11-48.
PubMed 21527006
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
- ClinicalTrials.gov ID
- NCT00298623
- Acronym / sponsor ID
- 110963
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 2 Mar 2006 (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 primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placebo |
| XP13512 (GSK1838262) | Experimental | Drug: XP13512 (GSK1838262) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
- History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
- Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Baseline study period;
- Total RLS severity score of 15 or greater on the International Restless Legs Syndrome Study Group Rating Scale (IRLS rating scale) at Visit 1 and at Visit 2;
- Discontinuation of dopamine agonists and/or gabapentin at least 2 weeks prior to Baseline;
Key exclusion criteria (5 listed)
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
- Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
- Pregnant or lactating women;
- Women of childbearing potential who are not practicing an acceptable method of birth control.
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 |
|---|---|---|
| XP13512 (GSK1838262) | Drug | XP13512 (GSK1838262) |
| placebo | Other | Placebo |
Primary outcome
The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.
Time frame: 12-week treatment period
The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement
Time frame: 12-week treatment period
1 secondary outcome
Onset of efficacy. Subjective measures of sleep.
Time frame: 12-week treatment period
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 14 May 2013.
- Background: PubMed 19238802Kushida CA, Walters AS, Becker P, Thein SG, Perkins AT, Roth T, Canafax D, Barrett RW; XP021 Study Group. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep. 2009 Feb;32(2):159-68. doi: 10.1093/sleep/32.2.159.
- Derived from this study: PubMed 27288210Ahmed M, Hays R, Steven Poceta J, Jaros MJ, Kim R, Shang G. Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials. Clin Ther. 2016 Jul;38(7):1726-1737.e1. doi: 10.1016/j.clinthera.2016.05.008. Epub 2016 Jun 7.
- Derived from this study: PubMed 27067343Avidan AY, Lee D, Park M, Jaros MJ, Shang G, Kim R. The Effect of Gabapentin Enacarbil on Quality of Life and Mood Outcomes in a Pooled Population of Adult Patients with Moderate-to-Severe Primary Restless Legs Syndrome. CNS Drugs. 2016 Apr;30(4):305-16. doi: 10.1007/s40263-016-0329-4.
- Derived from this study: PubMed 26788345Ondo WG, Hermanowicz N, Borreguero DG, Jaros MJ, Kim R, Shang G. Effect of prior exposure to dopamine agonists on treatment with gabapentin enacarbil in adults with moderate-to-severe primary restless legs syndrome: pooled analyses from 3 randomized trials. J Clin Mov Disord. 2015 Mar 30;2:9. doi: 10.1186/s40734-015-0018-3. eCollection 2015.
- Derived from this study: PubMed 21527006Canafax DM, Bhanegaonkar A, Bharmal M, Calloway M. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials. BMC Neurol. 2011 Apr 28;11:48. doi: 10.1186/1471-2377-11-48.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XP13512 (GSK1838262) in people with Restless Legs Syndrome, run by XenoPort, 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 9 inclusion and 5 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 14 May 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. 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 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 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 change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score. (time frame: 12-week treatment period). 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?
On the ClinicalTrials.gov record for NCT00298623, which also lists 5 linked publications.
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 14 May 2013.