Back to resultsAn Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS (RLS)
Primary Purpose
RLS
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
HORIZANT 600 mg
Sponsored by
About this trial
This is an interventional treatment trial for RLS focused on measuring Restless Legs Syndrome, RLS
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
- Stanford Sleep Medicine Center
- Pacific Research NetworkRecruiting
- NW FL Clinical Research Group
- Florida Pediatric Research InstituteRecruiting
- Clinical Integrative Research Center of Atlanta, INC
- Josephson Wallack Munshower Neurology, PCRecruiting
- Dent Neurologic Institute
- Mercy Health - Children's Hospital Pulmonary & Sleep Center
- The Sleep Center at the Childrens Hospital of Philadelphia
- SleepMed of South Carolina; SleepMed, Inc.Recruiting
- Vanderbilt University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HORIZANT 600 mg
Arm Description
HORIZANT 600 mg once daily
Outcomes
Primary Outcome Measures
Clinical Global Impression of Improvement (CGI-I) score
assessment at designated timepoints
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02633683
Brief Title
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
Acronym
RLS
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XenoPort, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RLS
Keywords
Restless Legs Syndrome, RLS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HORIZANT 600 mg
Arm Type
Experimental
Arm Description
HORIZANT 600 mg once daily
Intervention Type
Drug
Intervention Name(s)
HORIZANT 600 mg
Other Intervention Name(s)
Gabapentin Enacarbil Extended-Release Tablets
Intervention Description
HORIZANT 600 mg once daily
Primary Outcome Measure Information:
Title
Clinical Global Impression of Improvement (CGI-I) score
Description
assessment at designated timepoints
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Alexander
Phone
520-252-1908
Email
Camilla.Alexander@wwctrials.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Caras, MD
Organizational Affiliation
Xenoport/Arbor Pharmaceuticals, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Sleep Medicine Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dixie Creager
Phone
619-294-4302
Email
dcreager@prnsd.com
First Name & Middle Initial & Last Name & Degree
Jamie Jjirk
Phone
619-294-4302
Email
jjirik@prnsd.com
First Name & Middle Initial & Last Name & Degree
Stephen Thein, PhD
Facility Name
NW FL Clinical Research Group
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Individual Site Status
Withdrawn
Facility Name
Florida Pediatric Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Patenaude
Phone
407-898-2767
Ext
240
Email
heidi@ajayihealthcare.com
First Name & Middle Initial & Last Name & Degree
Sarah Simonian
Phone
407-898-2767
Ext
140
Email
sarah@ajayihealthcare.com
First Name & Middle Initial & Last Name & Degree
Akinyemi Ajayi, MD
Facility Name
Clinical Integrative Research Center of Atlanta, INC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Withdrawn
Facility Name
Josephson Wallack Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristi Mann
Phone
317-537-6088
Ext
1229
Email
kcleveland@jwmneuro.com
First Name & Middle Initial & Last Name & Degree
Kristina Cleveland
Phone
317-806-6965
Email
kcleveland@jwmneuro.com
First Name & Middle Initial & Last Name & Degree
Ridel, MD
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mercy Health - Children's Hospital Pulmonary & Sleep Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Individual Site Status
Terminated
Facility Name
The Sleep Center at the Childrens Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Withdrawn
Facility Name
SleepMed of South Carolina; SleepMed, Inc.
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Scallon, CRC
Phone
803-251-1093
Email
nscallon@sleepmedinc.com
First Name & Middle Initial & Last Name & Degree
Richard Bogan, MD
Facility Name
Vanderbilt University School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
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