RLSPhase 4RLSNCT02633683
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
A Phase 4 study testing HORIZANT 600 mg in people with RLS, run by XenoPort, Inc. at 11 sites in United States.
Trial summary
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- RLS
- What is being tested?
- HORIZANT 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2016to Jul 2024
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who completed participation in HORIZANT Study XP109.
- Negative pregnancy test for females of childbearing potential. Male patients able to father a child must agree to use a barrier method (male condom, female condom, diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study. Fertile, sexually active patients must agree to use 2 medically accepted methods of contraception
- Patients must be willing to refrain from using any drugs that are likely to affect RLS or sleep assessments for the duration of the study.
- Signed patient and parent (or legal guardian) Institutional Review Board (IRB)-approved assent and consent forms before any study procedures are carried out
Who cannot join
- Patients who, in the opinion of the investigator, would be noncompliant with the study visit schedule, procedures, or medication administration
- Patients who have developed clinically significant or unstable medical conditions, or who would otherwise be unsuitable for participation in a continuation study with gabapentin enacarbil
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 4 recruiting
- Withdrawn
Dent Neurologic Institute
Amherst, New York, 14226
- Withdrawn
Clinical Integrative Research Center of Atlanta, INC
Atlanta, Georgia, 30328
- Recruiting
SleepMed of South Carolina; SleepMed, Inc.
Columbia, South Carolina, 29201
Natalie Scallon, CRC, 803-251-1093, nscallon@sleepmedinc.com
Richard Bogan, MD
- Withdrawn
NW FL Clinical Research Group
Gulf Breeze, Florida, 32561
- Recruiting
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
Kristi Mann, 317-537-6088 ext. 1229, kcleveland@jwmneuro.com
Kristina Cleveland, 317-806-6965, kcleveland@jwmneuro.com
- Withdrawn
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232
- Withdrawn
The Sleep Center at the Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Withdrawn
Stanford Sleep Medicine Center
Redwood City, California, 94063
- Recruiting
Pacific Research Network
San Diego, California, 92103
Dixie Creager, 619-294-4302, dcreager@prnsd.com
Jamie Jjirk, 619-294-4302, jjirik@prnsd.com
- Terminated
Mercy Health - Children's Hospital Pulmonary & Sleep Center
Toledo, Ohio, 43608
- Recruiting
Florida Pediatric Research Institute
Winter Park, Florida, 32789
Heidi Patenaude, 407-898-2767 ext. 240, heidi@ajayihealthcare.com
Sarah Simonian, 407-898-2767 ext. 140, sarah@ajayihealthcare.com
About this study
Official title: A Multicenter Open-Label Extension Study to Evaluate the Efficacy and Safety of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary Restless Legs Syndrome
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.
Read the detailed description
Patients who complete the 12-week daily dosing efficacy and safety study (XP109) will be allowed to enroll in the open-label extension (OLE) study (XP110), thereby providing exposure to HORIZANT for up to 48 weeks. Enrolled patients will take open-label HORIZANT 600 mg tablets once a day at approximately 5 PM with food, beginning at Week 0 of the OLE study up to and including Week 36. After the end of the treatment period, a follow-up visit will be included 14 days (± 3 days) after the last dose of HORIZANT. Patients will visit the clinical site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last dose of study drug.
- Conditions
- RLS
- Being tested
- HORIZANT 600 mg
- Keywords
- Restless Legs Syndrome, 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.
HORIZANT 600 mgDrug
Also called Gabapentin Enacarbil Extended-Release Tablets
HORIZANT 600 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| HORIZANT 600 mg | Experimental | HORIZANT 600 mg once daily Receives: Drug: HORIZANT 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression of Improvement (CGI-I) score
assessment at designated timepoints
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RLSStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Caras, MD, Study director, Xenoport/Arbor Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633683
- Sponsor's protocol ID
- XP110
- Acronym
- RLS
- Status last verified
- Jun 2021
- First submitted
- 10 Dec 2015
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Extension Study to Evaluate the Efficacy and Safety of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT02633683
- Acronym / sponsor ID
- RLS / XP110
- Conditions
- RLS
- Keywords
- Restless Legs Syndrome, RLS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 17 Dec 2015 (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 objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.
Detailed description
Patients who complete the 12-week daily dosing efficacy and safety study (XP109) will be allowed to enroll in the open-label extension (OLE) study (XP110), thereby providing exposure to HORIZANT for up to 48 weeks. Enrolled patients will take open-label HORIZANT 600 mg tablets once a day at approximately 5 PM with food, beginning at Week 0 of the OLE study up to and including Week 36. After the end of the treatment period, a follow-up visit will be included 14 days (± 3 days) after the last dose of HORIZANT. Patients will visit the clinical site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HORIZANT 600 mg | Experimental | Drug: HORIZANT 600 mgHORIZANT 600 mg once daily |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients who completed participation in HORIZANT Study XP109.
- Negative pregnancy test for females of childbearing potential. Male patients able to father a child must agree to use a barrier method (male condom, female condom, diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study. Fertile, sexually active patients must agree to use 2 medically accepted methods of contraception
- Patients must be willing to refrain from using any drugs that are likely to affect RLS or sleep assessments for the duration of the study.
- Signed patient and parent (or legal guardian) Institutional Review Board (IRB)-approved assent and consent forms before any study procedures are carried out
Key exclusion criteria (2 listed)
- Patients who, in the opinion of the investigator, would be noncompliant with the study visit schedule, procedures, or medication administration
- Patients who have developed clinically significant or unstable medical conditions, or who would otherwise be unsuitable for participation in a continuation study with gabapentin enacarbil
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 |
|---|---|---|
| HORIZANT 600 mgAlso: Gabapentin Enacarbil Extended-Release TabletsHORIZANT 600 mg once daily | Drug | HORIZANT 600 mg |
Primary outcome
Clinical Global Impression of Improvement (CGI-I) score
Time frame: Week 12
assessment at designated timepoints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Steven Caras, MD study director
Xenoport/Arbor Pharmaceuticals, LLC
11 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 HORIZANT 600 mg in people with RLS, run by XenoPort, Inc. at 11 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Alexander (520-252-1908, Camilla.Alexander@wwctrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression of Improvement (CGI-I) score (time frame: Week 12). 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 9 Jun 2021.