Restless Legs SyndromePhase 2XP081NCT01332305

Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome

A Phase 2 study testing GEn (XP13512/GSK1838262) in people with Restless Legs Syndrome, run by XenoPort, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with 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?: GEn (XP13512/GSK1838262)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 217 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Jan 2008
Phase: Phase 2
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 at least 18 years of age
RLS, based on the IRLSSG Diagnostic Criteria
History of RLS symptoms occurring at least 15 nights in the month prior to Screening or, if on RLS treatment, this frequency of symptoms must have been applicable prior to start of treatment
Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights
Total RLS severity score of 15 or greater on the IRLS Rating Scale
If taking dopamine agonists, gabapentin, or other treatments for RLS (e.g., opioids, benzodiazepines) medications must have been discontinued at least 2 weeks prior to Screening;

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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;
Body Mass Index (BMI) 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
history of RLS symptom augmentation or end of dose rebound with previous dopamine agonist treatment
neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias);
other clinically significant or unstable medical condition or conditions which could affect RLS treatment efficacy assessments
serum ferritin level below 20 ng/mL
currently suffering from moderate or severe depression using the Diagnostic and Statistical Manual of Mental Disorders and Treatment IV (DSM IV TR)

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Dallas, Texas, 75213

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy, Safety, and Pharmacokinetics of XP13512 (GSK1838262) in Patients With Restless Legs Syndrome

Read the detailed description

This was a multicenter, randomized, double blind, placebo controlled, parallel group study, comparing 4 doses of GEn (XP13512) with placebo given once daily to subjects with RLS. Eligible subjects were randomized in equal numbers into 1 of 5 treatment groups (GEn 600 mg, 1200 mg, 1800 mg, or 2400 mg or placebo) for 12 weeks of treatment. Data from this study will be utilized as part of a larger pharmacokinetic (PK) pharmacodynamic (PD) analysis of data from several studies (XP084/RXP111495) that are part of the GEn RLS clinical development program. Safety and tolerability were also assessed.

Conditions: Restless Legs Syndrome
Being tested: GEn (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.

GEn (XP13512/GSK1838262)Drug
Also called XP13512, GSK1838262
Double-Blind Treatment Phase: 600 mg GEn (XP13512) orally, once daily for 3 days followed by 600 or 1200 mg on days 4-6, followed by 600 or 1200 or 1800 mg on days 7-9, followed by 600 or 1200 or 1800 or 2400 mg on days 10-84. Double-Blind Taper Phase: 600 or 1200 or 1800 mg GEn (XP13512) orally, once daily on days 85-86, followed by 600 mg or 1200 mg on days 87-88, followed by 600 mg on days 89-91
PlaceboDrug
Placebo orally once daily

Study groups in NCT01332305
Study group	Role	What they receive
GEn (XP13512/GSK1838262) 600 mg	Experimental	GEn (XP13512/GSK1838262) 600 mg Receives: Drug: GEn (XP13512/GSK1838262)
GEn (XP13512/GSK1838262) 1200 mg	Experimental	GEn (XP13512/GSK1838262) 1200 mg Receives: Drug: GEn (XP13512/GSK1838262)
GEn (XP13512/GSK1838262) 1800 mg	Experimental	GEn (XP13512/GSK1838262) 1800 mg Receives: Drug: GEn (XP13512/GSK1838262)
GEn (XP13512/GSK1838262) 2400 mg	Experimental	GEn (XP13512/GSK1838262) 2400 mg Receives: Drug: GEn (XP13512/GSK1838262)
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Css, Max and Css, Min
Css, max is defined as the maximum or "peak" concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.
Measured: Weeks 4 and 12
Mean Tmax and T1/2
Tmax is defined as the time to the maximum or "peak" concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.
Measured: Weeks 4 and 12
Mean AUCss
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.
Measured: Weeks 4 and 12

Timeline

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

Jan 2007Jan 2008

First posted11 Apr 2011 (estimated)
Study startJan 2007
Primary completionJan 2008
Study completionJan 2008

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.
Publications (4)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332305
Sponsor's protocol ID: 111462
Acronym: XP081
Status last verified: May 2011
First submitted: 7 Apr 2011
Last updated: 22 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ahmed 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 27288210
Avidan 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 27067343
Ondo 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 26788345
Lal R, Ellenbogen A, Chen D, Zomorodi K, Atluri H, Luo W, Tovera J, Hurt J, Bonzo D, Lassauzet ML, Vu A, Cundy KC. A randomized, double-blind, placebo-controlled, dose-response study to assess the pharmacokinetics, efficacy, and safety of gabapentin enacarbil in subjects with restless legs syndrome. Clin Neuropharmacol. 2012 Jul-Aug;35(4):165-73. doi: 10.1097/WNF.0b013e318259eac8.
PubMed 22664749

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 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy, Safety, and Pharmacokinetics of XP13512 (GSK1838262) in Patients With Restless Legs Syndrome
ClinicalTrials.gov ID: NCT01332305
Acronym / sponsor ID: XP081 / 111462
Conditions: Restless Legs Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: XenoPort, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 11 Apr 2011 (estimated)
Results: Posted 26 May 2011

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
GEn (XP13512/GSK1838262) 600 mg	Experimental	Drug: GEn (XP13512/GSK1838262)GEn (XP13512/GSK1838262) 600 mg
GEn (XP13512/GSK1838262) 1200 mg	Experimental	Drug: GEn (XP13512/GSK1838262)GEn (XP13512/GSK1838262) 1200 mg
GEn (XP13512/GSK1838262) 1800 mg	Experimental	Drug: GEn (XP13512/GSK1838262)GEn (XP13512/GSK1838262) 1800 mg
GEn (XP13512/GSK1838262) 2400 mg	Experimental	Drug: GEn (XP13512/GSK1838262)GEn (XP13512/GSK1838262) 2400 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

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

Key inclusion criteria (9 listed)

Men or women at least 18 years of age
RLS, based on the IRLSSG Diagnostic Criteria
History of RLS symptoms occurring at least 15 nights in the month prior to Screening or, if on RLS treatment, this frequency of symptoms must have been applicable prior to start of treatment
Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights
Total RLS severity score of 15 or greater on the IRLS Rating Scale

Key exclusion criteria (6 listed)

a sleep disorder (e.g., sleep apnea) that may significantly 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 (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias);
other clinically significant or unstable medical condition or conditions which could affect RLS treatment efficacy assessments
serum ferritin level below 20 ng/mL

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
GEn (XP13512/GSK1838262)Also: XP13512, GSK1838262Double-Blind Treatment Phase: 600 mg GEn (XP13512) orally, once daily for 3 days followed by 600 or 1200 mg on days 4-6, followed by 600 or 1200 or 1800 mg on days 7-9, followed by 600 or 1200 or 1800 or 2400 mg on days 10-84. Double-Blind Taper Phase: 600 or 1200 or 1800 mg GEn (XP13512) orally, once daily on days 85-86, followed by 600 mg or 1200 mg on days 87-88, followed by 600 mg on days 89-91	Drug	GEn (XP13512/GSK1838262) 1200 mg, GEn (XP13512/GSK1838262) 1800 mg, GEn (XP13512/GSK1838262) 2400 mg, GEn (XP13512/GSK1838262) 600 mg
PlaceboPlacebo orally once daily	Drug	Placebo

Primary outcome

Mean Css, Max and Css, Min
Time frame: Weeks 4 and 12
Css, max is defined as the maximum or "peak" concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.
Mean Tmax and T1/2
Time frame: Weeks 4 and 12
Tmax is defined as the time to the maximum or "peak" concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.
Mean AUCss
Time frame: Weeks 4 and 12
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.

Results and safety

Results posted to the registry on 26 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GEn Placebo	41	31
GEn 600 mg	48	34
GEn 1200 mg	45	31
GEn 1800 mg	38	30
GEn 2400 mg	45	33

Primary outcome: Mean Css, Max and Css, Min

Time frame: Weeks 4 and 12. Mean (Standard Deviation). Unit: nanograms per milliliter (ng/ml)

Measure	GEn Placebo n = 0	GEn 600 mg n = 39	GEn 1200 mg n = 33	GEn 1800 mg n = 33	GEn 2400 mg n = 36
Css, max; Week 4, n=0, 39, 33, 33, 36	–	3.86 (1.25)	7.14 (2.62)	11.4 (3.54)	14.0 (4.23)
Css, max; Week 12, n=0, 32, 30, 30, 31	–	4.14 (1.19)	7.15 (2.76)	12.0 (3.83)	13.3 (3.83)
Css, min; Week 4, n=0, 39, 33, 33, 36	–	0.690 (0.359)	1.37 (0.894)	1.63 (0.967)	2.34 (1.78)
Css, min; Week 12, n=0, 32, 30, 30, 31	–	0.600 (0.332)	1.32 (1.15)	1.60 (0.994)	2.41 (1.29)

Population analysed: Safety Population: all participants (par.) who were randomized and received at least one (or any portion of a) dose of study drug. Population was analyzed as randomized. Placebo par. had no exposure to GEn and were not included in the PK assessments. Of par. who completed the study, some were not included at W12 (sample not taken or BLQ).

Primary outcome: Mean Tmax and T1/2

Time frame: Weeks 4 and 12. Mean (Standard Deviation). Unit: hours

Measure	GEn Placebo n = 0	GEn 600 mg n = 39	GEn 1200 mg n = 33	GEn 1800 mg n = 33	GEn 2400 mg n = 36
Tmax; Week 4, n=0, 39, 33, 33, 36	–	8.76 (3.81)	8.57 (3.16)	7.61 (2.67)	8.01 (3.62)
Tmax; Week 12, n=0, 32, 30, 30, 31	–	6.96 (3.76)	8.72 (3.68)	8.00 (2.58)	8.13 (3.20)
T1/2; Week 4, n=0, 38, 33, 33, 35	–	5.82 (1.46)	6.67 (1.94)	5.82 (1.56)	6.05 (1.11)
T1/2, Week 12, n=0, 32, 30, 30, 30	–	6.27 (1.77)	6.63 (2.23)	5.89 (1.36)	6.09 (1.28)

Population analysed: Safety Population. Placebo participants (par.) were not included in the PK assessments, as they had no exposure to GEn. At W4, there were two par. excluded from the T1/2, as a result of no sample taken or a PK profile not possible. Of par. who completed the study, some were not included at W12 (sample not taken or below limit of quantitation).

Primary outcome: Mean AUCss

Time frame: Weeks 4 and 12. Mean (Standard Deviation). Unit: ng*hour/ml

Measure	GEn Placebo n = 0	GEn 600 mg n = 38	GEn 1200 mg n = 33	GEn 1800 mg n = 33	GEn 2400 mg n = 35
Week 4, n=0, 38, 33, 33, 35	–	49.3 (14.8)	96.1 (30.4)	141 (41.0)	176 (53.8)
Week 12, n=0, 32, 30, 30, 30	–	51.4 (16.5)	95.7 (38.5)	146 (41.4)	173 (54.4)

Population analysed: Safety Population. Placebo participants were not included in the PK assessments, as they had no exposure to GEn. Of participants who completed the study, some were not included at Week 12 (sample not taken or below limit of quantitation).

Adverse events

Time frame: Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GEn Placebo	1 of 41 (2.4%)	21 of 41 (51.2%)	Not reported
GEn 600 mg	0 of 48 (0%)	24 of 48 (50%)	Not reported
GEn 1200 mg	1 of 45 (2.2%)	33 of 45 (73.3%)	Not reported
GEn 1800 mg	0 of 38 (0%)	25 of 38 (65.8%)	Not reported
GEn 2400 mg	1 of 45 (2.2%)	42 of 45 (93.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 22664749Lal R, Ellenbogen A, Chen D, Zomorodi K, Atluri H, Luo W, Tovera J, Hurt J, Bonzo D, Lassauzet ML, Vu A, Cundy KC. A randomized, double-blind, placebo-controlled, dose-response study to assess the pharmacokinetics, efficacy, and safety of gabapentin enacarbil in subjects with restless legs syndrome. Clin Neuropharmacol. 2012 Jul-Aug;35(4):165-73. doi: 10.1097/WNF.0b013e318259eac8.

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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

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 GEn (XP13512/GSK1838262) in people with Restless Legs Syndrome, run by XenoPort, Inc. 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 9 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 22 Jul 2013. 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. 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 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?

Yes. Results are posted in the registry (first posted 26 May 2011). 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?

Mean Css, Max and Css, Min (time frame: Weeks 4 and 12). The study lists 3 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 NCT01332305, which also lists 4 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 22 Jul 2013.