RLSPhase 1RLSNCT02633657
A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS
A Phase 1 study testing HORIZANT 300 mg in people with RLS, run by XenoPort, Inc. at 4 sites in United States.
Trial summary
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to 19 Jul 2017
- Phase
- Phase 1
- 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, which is presented in Appendix 2.
- Total RLS severity score of 15 or greater on the IRLS rating scale at screening.
- Body weight greater than 33.4 kg and a healthy weight using age-based body mass index (BMI) range 5th to 85th percentile. Appendix 3 contains BMI-for-age charts that can be consulted.
- Negative pregnancy test for females of childbearing potential. Female patients of childbearing potential must agree to use one of the following acceptable birth control methods:
- intrauterine device in place for at least 3 months prior to dosing
- barrier methods (male condom, female condom, diaphragm or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study
Show all 9Show fewer
- stable hormonal contraceptive (including oral, injection, or implants) for at least 3 months prior to dosing and throughout the study 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 effective methods of birth control as described above.
- 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. 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.
- Signed patient/parent Institutional Review Board (IRB)-approved informed consent/assent form (as applicable) prior to any study procedures.
Who cannot join
- History of allergy, hypersensitivity or intolerance to HORIZANT or any other gabapentin compounds.
- Suffering from a movement disorder that could mimic or confound the accurate diagnosis of RLS (eg, Tourette's syndrome, tic disorder, periodic limb movement disorder [PLMD], sleep disorders).
- Currently meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for substance use disorder, or history thereof, within 12 months prior to dosing.
- Current or past history of any significant psychiatric disorder including but not limited to depression (treatment with antidepressants), bipolar disorder or schizophrenia.
- History of suicidal behavior or suicidal ideation as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening (the questionnaire is presented in Appendix 4), and as per investigator's judgment.
- History of seizure disorder or at increased risk for development of a seizure disorder, including but not limited to complicated febrile seizure and history of significant head injury.
- Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of gabapentin enacarbil, or, in the 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
SleepMed of South Carolina; SleepMed, Inc.
Columbia, South Carolina, 29201
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232
Stanford Sleep Medicine Center
Redwood City, California, 94063
Pacific Research Network
St Louis, Missouri, 63179
About this study
Official title: A Multicenter, Open-label, Single-dose Pharmacokinetic and Safety Evaluation of HORIZANT (Gabapentin Enacarbil Extended-release Tablets) in Adolescents Aged 13 to 17 Years Old With Moderate-to-severe Primary Restless Legs Syndrome
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).
Read the detailed description
One-treatment, 1-period study in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Patients will check-in at the clinical site in the evening of Day -1 or the morning of Day 0, and baseline safety assessments will be performed. On Day 0, after the review of these safety assessments and confirmation of eligibility, patients will receive a single oral 300 mg dose of HORIZANT with a meal (at approximately 6 AM). Study assessments will continue until approximately 14 hours (h) post dose, at which time patients will be discharged. Prior to discharge, patients will be advised not to drive a car or operate other complex machinery for at least 30 h after dosing; therefore, patients can remain at the clinical site overnight or can be escorted home. Patients will return to the clinical site for a follow-up visit 7 days (± 1 day) post dose.
- Conditions
- RLS
- Being tested
- HORIZANT 300 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 300 mgDrug
Also called gabapentin enacarbil
HORIZANT 300 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| HORIZANT 300 mg | Experimental | HORIZANT 300 mg once daily Receives: Drug: HORIZANT 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUC0-tlast).
AUCtlast
Measured: 0-14 hours
Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)
AUCinf
Measured: 0-14 hours
Percentage of AUCinf that is extrapolated from time of last measurable concentration to infinity (AUCextr%)
% AUCinf
Measured: 0-14 hours
Maximum observed plasma drug concentration (Cmax)
Cmax
Measured: 0-14 hours
Time to maximum concentration (Tmax)
Tmax
Measured: 0-14 hours
Apparent elimination half-life (T1/2)
T1/2
Measured: 0-14 hours
Apparent oral clearance (CL/F)
CL/F
Measured: 0-14 hours
Apparent oral volume of distribution (Vd/F)
Vd/F
Measured: 0-14 hours
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: 7 days
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 completion19 Jul 2017
- Study completion19 Jul 2017
Why it stopped: lack of enrollment
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT02633657
- Sponsor's protocol ID
- XP108
- Acronym
- RLS
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2015
- Last updated
- 12 Apr 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 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-dose Pharmacokinetic and Safety Evaluation 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
- NCT02633657
- Acronym / sponsor ID
- RLS / XP108
- Conditions
- RLS
- Keywords
- Restless Legs Syndrome, RLS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- 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 primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe Primary Restless Legs Syndrome (RLS).
Detailed description
One-treatment, 1-period study in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS. Patients will check-in at the clinical site in the evening of Day -1 or the morning of Day 0, and baseline safety assessments will be performed. On Day 0, after the review of these safety assessments and confirmation of eligibility, patients will receive a single oral 300 mg dose of HORIZANT with a meal (at approximately 6 AM). Study assessments will continue until approximately 14 hours (h) post dose, at which time patients will be discharged. Prior to discharge, patients will be advised not to drive a car or operate other complex machinery for at least 30 h after dosing; therefore, patients can remain at the clinical site overnight or can be escorted home. Patients will return to the clinical site for a follow-up visit 7 days (± 1 day) post dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HORIZANT 300 mg | Experimental | Drug: HORIZANT 300 mgHORIZANT 300 mg once daily |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male and female adolescent patients, aged 13 to 17 years, diagnosed with RLS based on the IRLSSG consensus criteria, which is presented in Appendix 2.
- Total RLS severity score of 15 or greater on the IRLS rating scale at screening.
- Body weight greater than 33.4 kg and a healthy weight using age-based body mass index (BMI) range 5th to 85th percentile. Appendix 3 contains BMI-for-age charts that can be consulted.
- Negative pregnancy test for females of childbearing potential. Female patients of childbearing potential must agree to use one of the following acceptable birth control methods:
- 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. 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.
Key exclusion criteria (7 listed)
- History of allergy, hypersensitivity or intolerance to HORIZANT or any other gabapentin compounds.
- Suffering from a movement disorder that could mimic or confound the accurate diagnosis of RLS (eg, Tourette's syndrome, tic disorder, periodic limb movement disorder [PLMD], sleep disorders).
- Currently meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for substance use disorder, or history thereof, within 12 months prior to dosing.
- Current or past history of any significant psychiatric disorder including but not limited to depression (treatment with antidepressants), bipolar disorder or schizophrenia.
- History of suicidal behavior or suicidal ideation as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening (the questionnaire is presented in Appendix 4), and as per investigator's judgment.
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 enacarbilHORIZANT 300 mg once daily | Drug | HORIZANT 300 mg |
Primary outcome
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUC0-tlast).
Time frame: 0-14 hours
AUCtlast
Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)
Time frame: 0-14 hours
AUCinf
Percentage of AUCinf that is extrapolated from time of last measurable concentration to infinity (AUCextr%)
Time frame: 0-14 hours
% AUCinf
Maximum observed plasma drug concentration (Cmax)
Time frame: 0-14 hours
Cmax
Time to maximum concentration (Tmax)
Time frame: 0-14 hours
Tmax
Apparent elimination half-life (T1/2)
Time frame: 0-14 hours
T1/2
Apparent oral clearance (CL/F)
Time frame: 0-14 hours
CL/F
Apparent oral volume of distribution (Vd/F)
Time frame: 0-14 hours
Vd/F
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HORIZANT 300 mg in people with RLS, run by XenoPort, Inc. at 4 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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUC0-tlast). (time frame: 0-14 hours). The study lists 8 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 12 Apr 2021.