RLSPhase 4RLSNCT02560766
An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
A Phase 4 study testing HORIZANT 300 mg and HORIZANT 600 mg in people with RLS, run by XenoPort, Inc. at 12 sites in United States.
Trial summary
The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg, compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome (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 300 mg and HORIZANT 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2016to Oct 2023
- 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
- Male and female adolescent patients, aged 13 to 17 years, diagnosed with RLS based on the IRLSSG consensus criteria (Allen RP 2014) (Appendix 2).
- Total RLS severity score of 15 or greater on the IRLS rating scale at Visit 1 (screening) and at Visit 2 (baseline) (Appendix 8).
- RLS symptoms for at least 4 of 7 consecutive evenings/nights during the screening period.
- Body weight greater than 33.4 kg and a healthy weight using age-based body mass index (BMI) range 5th-95th percentile at screening and baseline.
- Negative pregnancy test for all females at screening and baseline. Sexually active patients must agree to use 2 medically accepted methods of contraception, 1 of which is a highly effective method (e.g., hormonal or intrauterine device [IUD]) [the second may be a barrier method (e.g., male condom, female condom, diaphragm or cervical cap)], during the course of the study treatment and for 4 weeks after the last dose of study treatment. For patients using hormonal contraceptives as one of the methods, the contraceptive should be stabilized for at least 3 months prior to screening.
- Female patients who normally abstain from sexual activity may be recruited, providing they remain abstinent during the study, or if they become sexually active, they must agree to use 2 effective methods of birth control as described above.
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- Male patients 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, if sexually active. Male patients who normally abstain from sexual activity may be recruited, providing they remain abstinent during the study, or if they become sexually active, they must agree to use a barrier method as described above.
- Estimated creatinine clearance of at least 60 mL/min (using the Cockcroft-Gault equation) at screening only.
- Appropriate cognitive and communication skills, as judged by the clinician, needed to complete study assessments.
- Signed patient and parent Institutional Review Board (IRB)-approved informed consent/assent form (as applicable) before any study-related procedures are performed.
- Willing and able to follow the study procedures.
Who cannot join
- History of a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS.
- Serum ferritin level < 20 ng/mL at screening.
- History of allergy, hypersensitivity, or intolerance to HORIZANT or any other gabapentin products (e.g., Neurontin®, Gralise®).
- Suffering from an isolated periodic limb movement disorder without RLS.
- Currently meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for substance use disorder, or history thereof, within 12 months before dosing.
- Current or past history of any significant psychiatric disorder including, but not limited to, depression (treatment with antidepressants), bipolar disorder, or schizophrenia.
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- Diagnosis of ADHD is allowed, provided the patient is not receiving medication(s) known to affect the assessment of RLS.
- History of suicidal behavior or suicidal ideation as indicated by the C-SSRS, administered at screening, and as per investigator's judgment.
- Patients with a history of epilepsy, subjects currently prescribed treatments for epilepsy, or subjects with a history of seizure in the last 5 years.
- Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of gabapentin enacarbil, or, in the Principal Investigator's judgment is considered to be clinically significant and may pose a safety concern, or, could interfere with the accurate assessment of safety or efficacy, or could potentially affect a patient's safety or study outcome.
- In the judgement of the Principal Investigator, clinically significant, abnormal laboratory result or physical examination finding not resolved by the time of baseline assessments.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody at screening.
- Uncontrolled hypertension defined as blood pressure (BP) ≥ 95 percentile adjusted for age, height, and sex, according to the tables published by the US Department of Health and Human Services 2005, at screening and before dosing. Appendix 5 contains the tables that can be consulted.
- Participated in an investigational drug trial within the 4 weeks before dosing or plans to participate in another study at any time during this study.
- Received an investigational product within 6 months prior to dosing.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites, 4 recruiting
- Withdrawn
Dent Neurologic Institute
Amherst, New York, 14226
- Withdrawn
PANDA Neurology/CIRCA
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
- Terminated
NW FL Clinical Research Group
Gulf Breeze, Florida, 32561
- Withdrawn
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
- 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
Road Runner Research
San Antonio, Texas, 78249
Sandy Benavidez, 210-598-4314, sbenavidez@rrresearchsa.com
Jerry Tomasovic, MD
- Recruiting
Pacific Research Network
St Louis, Missouri, 63179
Dixie Creager, 619-294-4302, dcreager@prnsd.com
Jamie Jjirik, jjirik@prnsd.com
- Terminated
Mercy Health - Children's Hospital Pulmonary & Sleep Center
Toledo, Ohio, 43608
- Recruiting
Orlando Pediatric Pulmonary and Sleep
Winter Park, Florida, 32789
Heidi Patenaude, 407-898-2767 ext. 240, heidi@ajayihealthcare.com
Sarah Simonian, 4078982767 ext. 140, paul@ajayihealthcare.com
About this study
Official title: A Multicenter, Double-Blind, Placebo Controlled, Parallel Group, Efficacy and Safety Evaluation of HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary RLS
The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg, compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome (RLS) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.
Read the detailed description
This is a multicenter, double-blind, placebo-controlled, 3 arm, parallel group study of HORIZANT in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Eligible patients enter a 7-day screening period during which safety assessments are performed. Eligible patients are randomized in a 1:1:1 ratio to HORIZANT 300 mg or 600 mg, or matching placebo, followed by a 12-week treatment period. Patients take the study drug once daily at approximately 5 PM with food. Patients will visit the clinical site on 5 or 6 different occasions.
- Conditions
- RLS
- Being tested
- HORIZANT 300 mg, HORIZANT 600 mg, Placebo
- Keywords
- Restless Leg 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 300 mgDrug
Also called Gabapentin Enacarbil Extended-Release Tablets
HORIZANT 300 mg once daily
HORIZANT 600 mgDrug
Also called Gabapentin Enacarbil Extended-Release Tablets
HORIZANT 600 mg once daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| HORIZANT 300 mg | Experimental | HORIZANT 300 mg once daily Receives: Drug: HORIZANT 300 mg |
| HORIZANT 600 mg | Experimental | HORIZANT 600 mg once daily Receives: Drug: HORIZANT 600 mg |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change on the IRLS rating scale from baseline to Week 12
IRLS rating change
Measured: 12 weeks
the proportion of patients who are responders, assessed on the CGI-I scale as "much improved" or "very much improved" (CGI-I rating of 1 or 2, respectively) at Week 12
CGI-I scale
Measured: 12 weeks
Secondary outcomes (5)
IRLS total score, change from baseline to Weeks 4 and 8
IRLS change
Measured: 4, 8 weeks
CGI-I score at Weeks 4 and 8
CGI-I score
Measured: 4, 8 weeks
Proportions of patients by sleep parameters collected on the Post-Sleep questionnaire at baseline and Week 12
sleep parameters on Post-Sleep questionnaire
Measured: Baseline to 12 weeks
Proportions of patients by sleep parameters collected on the ESS-CHAD© total score and change from baseline to Week 12
sleep parameters by ESS-CHAD© total score and change
Measured: Baseline to 12 weeks
Proportions of patients with AEs, fatal serious adverse events (SAEs), non-fatal SAEs, and discontinuations due to AEs at all post-dose time points; and proportion of patients with neuropsychiatric AEs
Adverse event proporations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startFeb 2016
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 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
- NCT02560766
- Sponsor's protocol ID
- XP109
- Acronym
- RLS
- Status last verified
- Jun 2021
- First submitted
- 23 Sep 2015
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- 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, Double-Blind, Placebo Controlled, Parallel Group, Efficacy and Safety Evaluation of HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary RLS
- ClinicalTrials.gov ID
- NCT02560766
- Acronym / sponsor ID
- RLS / XP109
- Conditions
- RLS
- Keywords
- Restless Leg Syndrome, RLS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 25 Sep 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 primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg, compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome (RLS) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.
Detailed description
This is a multicenter, double-blind, placebo-controlled, 3 arm, parallel group study of HORIZANT in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Eligible patients enter a 7-day screening period during which safety assessments are performed. Eligible patients are randomized in a 1:1:1 ratio to HORIZANT 300 mg or 600 mg, or matching placebo, followed by a 12-week treatment period. Patients take the study drug once daily at approximately 5 PM with food. Patients will visit the clinical site on 5 or 6 different occasions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HORIZANT 300 mg | Experimental | Drug: HORIZANT 300 mgHORIZANT 300 mg once daily |
| HORIZANT 600 mg | Experimental | Drug: HORIZANT 600 mgHORIZANT 600 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Male and female adolescent patients, aged 13 to 17 years, diagnosed with RLS based on the IRLSSG consensus criteria (Allen RP 2014) (Appendix 2).
- Total RLS severity score of 15 or greater on the IRLS rating scale at Visit 1 (screening) and at Visit 2 (baseline) (Appendix 8).
- RLS symptoms for at least 4 of 7 consecutive evenings/nights during the screening period.
- Body weight greater than 33.4 kg and a healthy weight using age-based body mass index (BMI) range 5th-95th percentile at screening and baseline.
- Negative pregnancy test for all females at screening and baseline. Sexually active patients must agree to use 2 medically accepted methods of contraception, 1 of which is a highly effective method (e.g., hormonal or intrauterine device [IUD]) [the second may be a barrier method (e.g., male condom, female condom, diaphragm or cervical cap)], during the course of the study treatment and for 4 weeks after the last dose of study treatment. For patients using hormonal contraceptives as one of the methods, the contraceptive should be stabilized for at least 3 months prior to screening.
Key exclusion criteria (15 listed)
- History of a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS.
- Serum ferritin level < 20 ng/mL at screening.
- History of allergy, hypersensitivity, or intolerance to HORIZANT or any other gabapentin products (e.g., Neurontin®, Gralise®).
- Suffering from an isolated periodic limb movement disorder without RLS.
- Currently meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for substance use disorder, or history thereof, within 12 months before dosing.
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 300 mgAlso: Gabapentin Enacarbil Extended-Release TabletsHORIZANT 300 mg once daily | Drug | HORIZANT 300 mg |
| HORIZANT 600 mgAlso: Gabapentin Enacarbil Extended-Release TabletsHORIZANT 600 mg once daily | Drug | HORIZANT 600 mg |
| PlaceboPlacebo once daily | Drug | Placebo |
Primary outcome
the change on the IRLS rating scale from baseline to Week 12
Time frame: 12 weeks
IRLS rating change
the proportion of patients who are responders, assessed on the CGI-I scale as "much improved" or "very much improved" (CGI-I rating of 1 or 2, respectively) at Week 12
Time frame: 12 weeks
CGI-I scale
5 secondary outcomes
IRLS total score, change from baseline to Weeks 4 and 8
Time frame: 4, 8 weeks
CGI-I score at Weeks 4 and 8
Time frame: 4, 8 weeks
Proportions of patients by sleep parameters collected on the Post-Sleep questionnaire at baseline and Week 12
Time frame: Baseline to 12 weeks
Proportions of patients by sleep parameters collected on the ESS-CHAD© total score and change from baseline to Week 12
Time frame: Baseline to 12 weeks
Proportions of patients with AEs, fatal serious adverse events (SAEs), non-fatal SAEs, and discontinuations due to AEs at all post-dose time points; and proportion of patients with neuropsychiatric AEs
Time frame: 12 weeks
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.
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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
12 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 300 mg and HORIZANT 600 mg in people with RLS, run by XenoPort, Inc. at 12 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 11 inclusion and 15 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 12 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?
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?
the change on the IRLS rating scale from baseline to Week 12 (time frame: 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?
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.