Restless Legs SyndromePhase 4CONCORDNCT01668667

Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study

A Phase 4 study testing GSK1838262 600 mg, GSK1838262 450 mg and GSK1838262 300 mg in people with Restless Legs Syndrome, run by XenoPort, Inc. at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Restless Legs Syndrome
What is being tested?: GSK1838262 600 mg, GSK1838262 450 mg and GSK1838262 300 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 501 participants
Where: 42 sitesUnited States
Study dates: Jun 2012to Nov 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 or women 18 years of age or older
History of RLS symptoms for at least 15 nights/month
Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night
Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2
Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline
If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study

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Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use a highly effective method for avoiding pregnancy
Body mass index of 34 or below
Estimated creatinine clearance of ≥60 mL/min
Provides written consent in accordance with all applicable regulatory requirements

Who cannot join

History of a sleep disorder that may affect the assessment of RLS
History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
Neurologic disease or movement disorder
Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern
Have clinically significant or unstable medical conditions
Have active suicidal plan/intent or has had active suicidal thoughts in the past 6 months; has a history of suicide attempt

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

GSK Investigational Site
Albuquerque, New Mexico, 87106
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Austin, Texas, 78731
GSK Investigational Site
Bingham Farms, Michigan, 48025
GSK Investigational Site
Charlottesville, Virginia, 22911
GSK Investigational Site
Chevy Chase, Maryland, 20815
GSK Investigational Site
Cincinnati, Ohio, 45255
GSK Investigational Site
Cleveland, Ohio, 44130
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Crestview Hills, Kentucky, 41017
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Denver, Colorado, 80239
GSK Investigational Site
Duncansville, Pennsylvania, 16635
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Hickory, North Carolina, 28601
GSK Investigational Site
Jackson, Tennessee, 38305
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Lenexa, Kansas, 66214
GSK Investigational Site
Little Rock, Arkansas, 72211
GSK Investigational Site
Louisville, Kentucky, 40217
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Middleburg Heights, Ohio, 44130
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Murray, Utah, 84123
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Phoenix, Arizona, 85020
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
San Angelo, Texas, 76904
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Tampa, Florida, 33609
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Tucson, Arizona, 85704
GSK Investigational Site
Warwick, Rhode Island, 02886
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in Treatment of Moderate-to-Severe Primary RLS

Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a condition of the approval of HORIZANT tablets (NDA 022399).

Read the detailed description

This is a Phase IV randomized, double-blind, placebo-controlled, fixed-dose, parallel group study to assess the efficacy, tolerability, and safety of 3 doses of GEn (600, 450, and 300 mg/day) compared with placebo in the treatment of subjects with moderate-to-severe primary RLS.

The study will include 9 visits over approximately 14 weeks for eligible subjects including a 1-week Screening Period, a 12-week Treatment Period, and a 1 week Follow up Period. Screening will occur within 1 week of the first scheduled dose of study medication. The total duration of the study, from the first subject enrolled to the last subject completed will be approximately 2 years.

Eligible subjects (at least 18 years of age) must have:

a diagnosis of RLS according to the IRLSSG Diagnostic Criteria
a history of RLS symptoms for 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 Screening Period, and a total RLS severity score of at least 15 on the International Restless Legs Syndrome (IRLS) Rating Scale at the screening and baseline visits

Approximately 498 subjects will be enrolled, randomly assigned to treatment groups, and receive study medication once daily for 12 weeks. Subjects will be randomly assigned to receive 1 of the 4 following treatment groups in a ratio of 1:1:1:1:

GEn 600 mg/day
GEn 450 mg/day
GEn 300 mg/day
Matching placebo

Subjects will be instructed to take their study medication once daily with food in the evening at approximately 5 PM. Each tablet must be swallowed whole and not divided, crushed, or chewed.

Each subject, regardless of treatment assignment, will take 3 tablets of study medication (1 tablet from Bottle A, 1 tablet from Bottle B, and 1 tablet from Bottle C) once daily continuing through the end of the Treatment Period (Week 12). Subjects will return to the study site for a follow-up visit (Visit 9, Week 13) approximately 1 week after the last dose of study medication.

Each subject's participation in the study will be approximately 14 weeks unless they withdraw early from the study. For subjects who complete the study, Visit 9 (which can occur between Day 86 and 92) will be considered their end-of-study visit.

Conditions: Restless Legs Syndrome
Being tested: GSK1838262 600 mg, GSK1838262 450 mg, GSK1838262 300 mg, GSK1838262 Placebo match
Keywords: gabapentin enacarbil, Horizant
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.

GSK1838262 600 mgDrug
Also called Horizant, gabapentin enacarbil GEn, XP13512
Drug: GSK1838262 600 mg/day Comparison of 3 doses
GSK1838262 450 mgDrug
Also called Horizant, gabapentin enacarbil GEn, XP13512
Drug: GSK1838262 450 mg/day Comparison of 3 doses
GSK1838262 300 mgDrug
Also called Horizant, gabapentin enacarbil GEn, XP13512
Drug: GSK1838262 300 mg/day Comparison of 3 doses
GSK1838262 Placebo matchDrug
Drug; GSK1838262 placebo to match 600 mg, 450 mg, 300 mg doses

Study groups in NCT01668667
Study group	Role	What they receive
GSK1838262 600 mg	Active comparator	Once-daily dose with food in the evening at approximately 5 PM Receives: Drug: GSK1838262 600 mg
GSK1838262 450 mg	Active comparator	Once-daily dose with food in the evening at approximately 5 PM Receives: Drug: GSK1838262 450 mg
GSK1838262 300 mg	Active comparator	Once-daily dose with food in the evening at approximately 5 PM Receives: Drug: GSK1838262 300 mg
GSK1838262 placebo match	Placebo comparator	Once-daily dose with food in the evening at approximately 5 PM Receives: Drug: GSK1838262 Placebo match

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 the International Restless Legs Syndrome (IRLS) Rating Scale Score
International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.
Change from Baseline = LOCF value at current visit - value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.
The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.
Measured: Baseline, 12 weeks
The Proportion of Subjects at the End of Treatment Who Are Responders With Either "Much Improved" or "Very Much Improved" on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)
Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.
Measured: 12 weeks

Secondary outcomes (2)

The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment
International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.
This model only includes treatment in the model. Least squares mean is used for analysis.
Measured: Baseline, 12 Weeks
The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment
Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Nov 2013

First posted20 Aug 2012 (estimated)
Study startJun 2012
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01668667
Sponsor's protocol ID: 114025
Acronym: CONCORD
Status last verified: Apr 2021
First submitted: 14 Jun 2012
Last updated: 24 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in Treatment of Moderate-to-Severe Primary RLS
ClinicalTrials.gov ID: NCT01668667
Acronym / sponsor ID: CONCORD / 114025
Conditions: Restless Legs Syndrome
Keywords: gabapentin enacarbil, Horizant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 501 participants (actual)
Lead sponsor: XenoPort, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 20 Aug 2012 (estimated)
Results: Posted 17 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Eligible subjects (at least 18 years of age) must have:

a diagnosis of RLS according to the IRLSSG Diagnostic Criteria
a history of RLS symptoms for 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 Screening Period, and a total RLS severity score of at least 15 on the International Restless Legs Syndrome (IRLS) Rating Scale at the screening and baseline visits

GEn 600 mg/day
GEn 450 mg/day
GEn 300 mg/day
Matching placebo

Subjects will be instructed to take their study medication once daily with food in the evening at approximately 5 PM. Each tablet must be swallowed whole and not divided, crushed, or chewed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GSK1838262 600 mg	Active comparator	Drug: GSK1838262 600 mgOnce-daily dose with food in the evening at approximately 5 PM
GSK1838262 450 mg	Active comparator	Drug: GSK1838262 450 mgOnce-daily dose with food in the evening at approximately 5 PM
GSK1838262 300 mg	Active comparator	Drug: GSK1838262 300 mgOnce-daily dose with food in the evening at approximately 5 PM
GSK1838262 placebo match	Placebo comparator	Drug: GSK1838262 Placebo matchOnce-daily dose with food in the evening at approximately 5 PM

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Men or women 18 years of age or older
History of RLS symptoms for at least 15 nights/month
Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night
Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2
Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline

Key exclusion criteria (6 listed)

History of a sleep disorder that may affect the assessment of RLS
History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
Neurologic disease or movement disorder
Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern
Have clinically significant or unstable medical conditions

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
GSK1838262 600 mgAlso: Horizant, gabapentin enacarbil GEn, XP13512Drug: GSK1838262 600 mg/day Comparison of 3 doses	Drug	GSK1838262 600 mg
GSK1838262 450 mgAlso: Horizant, gabapentin enacarbil GEn, XP13512Drug: GSK1838262 450 mg/day Comparison of 3 doses	Drug	GSK1838262 450 mg
GSK1838262 300 mgAlso: Horizant, gabapentin enacarbil GEn, XP13512Drug: GSK1838262 300 mg/day Comparison of 3 doses	Drug	GSK1838262 300 mg
GSK1838262 Placebo matchDrug; GSK1838262 placebo to match 600 mg, 450 mg, 300 mg doses	Drug	GSK1838262 placebo match

Primary outcome

The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score
Time frame: Baseline, 12 weeks
International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0. Change from Baseline = LOCF value at current visit - value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo. The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.
The Proportion of Subjects at the End of Treatment Who Are Responders With Either "Much Improved" or "Very Much Improved" on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)
Time frame: 12 weeks
Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.

2 secondary outcomes

The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment
Time frame: Baseline, 12 Weeks
The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment
Time frame: 12 Weeks

Results and safety

Results posted to the registry on 17 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK1838262 600 mg	126	95
GSK1838262 450 mg	125	99
GSK1838262 300 mg	125	94
GSK1838262 Placebo Match	125	102

Primary outcome: The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score

Time frame: Baseline, 12 weeks. Mean (Standard Error). Unit: units on a scale

Measure	GSK1838262 600 mg n = 119	GSK1838262 450 mg n = 112	GSK1838262 300 mg n = 111	GSK1838262 Placebo Match n = 117
Value	-12.50 (0.745)	-12.54 (0.764)	-11.48 (0.767)	-9.93 (0.753)

GSK1838262 600 mg vs GSK1838262 Placebo Match: Adjusted mean difference: -2.57 (95% CI -4.62 to -0.52), p = 0.014, ANCOVA
GSK1838262 450 mg vs GSK1838262 Placebo Match: Adjusted mean difference: -2.61 (95% CI -4.68 to -0.54), p = 0.014, ANCOVA
GSK1838262 300 mg vs GSK1838262 Placebo Match: Adjusted mean difference: -1.55 (95% CI -3.63 to 0.53), p = 0.144, ANCOVA

Population analysed: mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.

Primary outcome: The Proportion of Subjects at the End of Treatment Who Are Responders With Either "Much Improved" or "Very Much Improved" on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)

Time frame: 12 weeks. Number. Unit: percentage of participants

Measure	GSK1838262 600 mg n = 119	GSK1838262 450 mg n = 112	GSK1838262 300 mg n = 111	GSK1838262 Placebo Match n = 117
Value	67	67	68	50

GSK1838262 600 mg vs GSK1838262 Placebo Match: Odds Ratio (OR): 2.26 (95% CI 1.30 to 3.95), p = 0.004, Regression, Logistic
GSK1838262 450 mg vs GSK1838262 Placebo Match: Odds Ratio (OR): 2.15 (95% CI 1.23 to 3.77), p = 0.007, Regression, Logistic
GSK1838262 300 mg vs GSK1838262 Placebo Match: Odds Ratio (OR): 2.24 (95% CI 1.27 to 3.94), p = 0.005, Regression, Logistic

Population analysed: mITT (modified intent to treat) population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs are collected from the start of study medication and until the follow-up contact. SAEs are collected over the same time period as AEs. SAEs related to study participation are recorded from the time of consenting up to & including any follow-up contact. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1838262 600 mg	1 of 122 (0.8%)	55 of 122 (45.1%)	Not reported
GSK1838262 450 mg	0 of 123 (0%)	56 of 123 (45.5%)	Not reported
GSK1838262 300 mg	2 of 121 (1.7%)	33 of 121 (27.3%)	Not reported
GSK1838262 Placebo Match	1 of 121 (0.8%)	46 of 121 (38%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

42 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing GSK1838262 600 mg, GSK1838262 450 mg and GSK1838262 300 mg in people with Restless Legs Syndrome, run by XenoPort, Inc. at 42 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 10 inclusion and 6 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 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 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 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?

Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 the International Restless Legs Syndrome (IRLS) Rating Scale Score (time frame: Baseline, 12 weeks). 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 NCT01668667.

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 24 May 2021.