An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS

NCT02560766 | Unknown Phase 4

• 1 other identifier: XP109
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

RLS

Keywords

Restless Leg Syndrome; RLS

Outcome Measures

Primary Outcomes (2)

• the change on the IRLS rating scale from baseline to Week 12

  IRLS rating change

  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

  12 weeks

Secondary Outcomes (5)

• IRLS total score, change from baseline to Weeks 4 and 8

  4, 8 weeks

• CGI-I score at Weeks 4 and 8

  4, 8 weeks

• Proportions of patients by sleep parameters collected on the Post-Sleep questionnaire at baseline and Week 12

  Baseline to 12 weeks

• Proportions of patients by sleep parameters collected on the ESS-CHAD© total score and change from baseline to Week 12

  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

  12 weeks

Study Arms (3)

HORIZANT 300 mg

EXPERIMENTAL

HORIZANT 300 mg once daily

Drug: HORIZANT 300 mg

HORIZANT 600 mg

EXPERIMENTAL

HORIZANT 600 mg once daily

Drug: HORIZANT 600 mg

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

HORIZANT 300 mg DRUG

HORIZANT 300 mg once daily

Also known as: Gabapentin Enacarbil Extended-Release Tablets

HORIZANT 300 mg

HORIZANT 600 mg DRUG

HORIZANT 600 mg once daily

Also known as: Gabapentin Enacarbil Extended-Release Tablets

HORIZANT 600 mg

Placebo DRUG

Placebo once daily

Placebo

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 (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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (12)

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

WITHDRAWN

NW FL Clinical Research Group

Gulf Breeze, Florida, 32561, United States

TERMINATED

Orlando Pediatric Pulmonary and Sleep

Winter Park, Florida, 32789, United States

RECRUITING

PANDA Neurology/CIRCA

Atlanta, Georgia, 30328, United States

WITHDRAWN

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, 46256, United States

WITHDRAWN

Pacific Research Network

St Louis, Missouri, 63179, United States

RECRUITING

Dent Neurologic Institute

Amherst, New York, 14226, United States

WITHDRAWN

Mercy Health - Children's Hospital Pulmonary & Sleep Center

Toledo, Ohio, 43608, United States

TERMINATED

The Sleep Center at the Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

WITHDRAWN

SleepMed of South Carolina; SleepMed, Inc.

Columbia, South Carolina, 29201, United States

RECRUITING

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232, United States

WITHDRAWN

Road Runner Research

San Antonio, Texas, 78249, United States

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Gabapentin

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

Central Study Contacts

Camilla Alexander

CONTACT

520-252-1908; Camilla.Alexander@wwctrials.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 25, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

US (12)