A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS

NCT02633657 | Withdrawn Phase 1

• 1 other identifier: XP108
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

RLS

Keywords

Restless Legs Syndrome; RLS

Outcome Measures

Primary Outcomes (8)

• Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUC0-tlast).

  AUCtlast

  0-14 hours

• Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)

  AUCinf

  0-14 hours

• Percentage of AUCinf that is extrapolated from time of last measurable concentration to infinity (AUCextr%)

  % AUCinf

  0-14 hours

• Maximum observed plasma drug concentration (Cmax)

  Cmax

  0-14 hours

• Time to maximum concentration (Tmax)

  Tmax

  0-14 hours

• Apparent elimination half-life (T1/2)

  T1/2

  0-14 hours

• Apparent oral clearance (CL/F)

  CL/F

  0-14 hours

• Apparent oral volume of distribution (Vd/F)

  Vd/F

  0-14 hours

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

  7 days

Study Arms (1)

HORIZANT 300 mg

EXPERIMENTAL

HORIZANT 300 mg once daily

Drug: HORIZANT 300 mg

Interventions

HORIZANT 300 mg DRUG

HORIZANT 300 mg once daily

Also known as: gabapentin enacarbil

HORIZANT 300 mg

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (4)

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

Location

Pacific Research Network

St Louis, Missouri, 63179, United States

Location

SleepMed of South Carolina; SleepMed, Inc.

Columbia, South Carolina, 29201, United States

Location

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Gabapentin; 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Steven Caras, MD

  Xenoport/Arbor Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)