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An Open Label Study of FT218 in Subjects With Narcolepsy (RESTORE)

Primary Purpose

Narcolepsy, Cataplexy, Excessive Daytime Somnolence

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FT218
Sponsored by
Avadel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts oxybate for at least 4 weeks and are willing to switch to FT218
  • Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for whom the Investigator determines would receive benefit from treatment with FT218 and have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate
  • Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate)
  • Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study or as confirmed by the Investigator as defined by the International Classification of Sleep Disorders 3 criteria (AASM 2014)
  • Willing and able to give written informed consent for study participation. Young adults (16 and 17 years old) who have not reached the age of majority must be capable of giving assent in addition to consent from a legally authorized guardian, as required by local laws and regulations.

Exclusion Criteria:

  • Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8
  • Any use of the following medications during the study: Anticonvulsants, Clonidine, Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental medications designed to treat narcolepsy, cataplexy or any other condition, or other medications with significant sedating effects/CNS depressant effects are prohibited for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on medications in classes listed above may be eligible for enrollment if the subject has been on a stable dose of the prohibited medication in combination with a stable dose of twice nightly sodium oxybate or mixed salts oxybate for at least three months and has demonstrated no AEs, intolerance, or interactions AND is approved to participate by the Medical Monitor. Sedative hypnotics are prohibited regardless.)
  • A diagnosis of sleep apnea where AHI is ≥15 and/or current use of CPAP or other devices for sleep apnea.

Sites / Locations

  • Sleep Disorders Center of Alabama
  • Stanford Sleep Medicine
  • SDS Clinical Trials
  • Alpine Clinical Research Center
  • Delta Waves, Inc.
  • Pulmonary Disease Specialists, PA
  • Sleep Medicine Specialists of South Florida
  • FL Pediatric Research Institute
  • NeuroTrials Research Inc
  • SleepCare Research Institute, Inc. d/b/a Clinical Research Institute
  • Fort Wayne Neurological
  • Helene A. Emsellem, MD PC
  • Baystate Medical Center
  • St. Luke's Hospital - Sleep Medicine and Research Center
  • Montefiore Sleep-Wake Disorders Center
  • Advanced Respiratory and Sleep Medicine
  • Sleep Management Institute Intrepid Research
  • University Hospitals Cleveland Medical Center
  • Ohio Sleep Medicine Institute
  • Geisinger Medical Center
  • Brian Abaluck Sleep Medicine
  • Bogan Sleep Consultants, LLC
  • FutureSearch Trials of Neurology
  • Sleep Therapy & Research Center
  • Comprehensive Sleep Medicine Associates
  • Northwest Houston Neurology
  • TPMG Clinical Research Williamsburg
  • West Perry Sound Health Center
  • Jodha Tishon Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FT218

Arm Description

once nightly sodium oxybate extended release oral solution (FT218)

Outcomes

Primary Outcome Measures

Incidence of treatment-related adverse events
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
Incidence of clinically significant changes in vital signs
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs
Incidence of clinically significant changes in laboratory test results
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results

Secondary Outcome Measures

Full Information

First Posted
June 23, 2020
Last Updated
June 10, 2022
Sponsor
Avadel
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1. Study Identification

Unique Protocol Identification Number
NCT04451668
Brief Title
An Open Label Study of FT218 in Subjects With Narcolepsy
Acronym
RESTORE
Official Title
Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avadel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy
Detailed Description
This study will enroll subjects with narcolepsy, either NT1 or NT2, who completed the FT218 Phase 3 REST-ON study or eligible subjects with narcolepsy currently receiving a stable dose of twice nightly sodium oxybate IR or mixed salts oxybate (regardless of whether they participated in the REST-ON study), or subjects who are naïve to oxybate therapy (i.e., FT218, twice nightly sodium oxybate IR or mixed salts oxybate). Following a screening period, subjects who meet the entry criteria will be enrolled into the study. Subjects who completed the FT218 Phase 3 REST-ON study will initiate treatment with FT218 at 4.5 g and will follow a titration schedule up to the highest tolerate dose (up to 9 g), or the dose deemed effective by the investigator. Subjects previously maintained on twice nightly sodium oxybate IR will initiate FT218 treatment at a dose equivalent or closest to the total gram dose of twice-nightly sodium oxybate IR and then titrate up or down, in accord with safety and effectiveness as determined by the investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder, Sleep Disturbance, Sleep Wake Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open label treatment with FT218 (once nightly sodium oxybate extended release)
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FT218
Arm Type
Experimental
Arm Description
once nightly sodium oxybate extended release oral solution (FT218)
Intervention Type
Drug
Intervention Name(s)
FT218
Intervention Description
once nightly sodium oxybate extended release
Primary Outcome Measure Information:
Title
Incidence of treatment-related adverse events
Description
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
Time Frame
24 months
Title
Incidence of clinically significant changes in vital signs
Description
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs
Time Frame
24 months
Title
Incidence of clinically significant changes in laboratory test results
Description
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts oxybate for at least 4 weeks and are willing to switch to FT218 Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for whom the Investigator determines would receive benefit from treatment with FT218 and have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate) Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study or as confirmed by the Investigator as defined by the International Classification of Sleep Disorders 3 criteria (AASM 2014) Willing and able to give written informed consent for study participation. Young adults (16 and 17 years old) who have not reached the age of majority must be capable of giving assent in addition to consent from a legally authorized guardian, as required by local laws and regulations. Exclusion Criteria: Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8 Any use of the following medications during the study: Anticonvulsants, Clonidine, Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental medications designed to treat narcolepsy, cataplexy or any other condition, or other medications with significant sedating effects/CNS depressant effects are prohibited for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on medications in classes listed above may be eligible for enrollment if the subject has been on a stable dose of the prohibited medication in combination with a stable dose of twice nightly sodium oxybate or mixed salts oxybate for at least three months and has demonstrated no AEs, intolerance, or interactions AND is approved to participate by the Medical Monitor. Sedative hypnotics are prohibited regardless.) A diagnosis of sleep apnea where AHI is ≥15 and/or current use of CPAP or other devices for sleep apnea.
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Stanford Sleep Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
SDS Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Delta Waves, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Pulmonary Disease Specialists, PA
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Sleep Medicine Specialists of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
FL Pediatric Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
SleepCare Research Institute, Inc. d/b/a Clinical Research Institute
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Fort Wayne Neurological
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Helene A. Emsellem, MD PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
St. Luke's Hospital - Sleep Medicine and Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Montefiore Sleep-Wake Disorders Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Advanced Respiratory and Sleep Medicine
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Sleep Management Institute Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Brian Abaluck Sleep Medicine
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4849
Country
United States
Facility Name
Comprehensive Sleep Medicine Associates
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Northwest Houston Neurology
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
TPMG Clinical Research Williamsburg
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Facility Name
West Perry Sound Health Center
City
Parry Sound
State/Province
Ontario
ZIP/Postal Code
P2A 3A4
Country
Canada
Facility Name
Jodha Tishon Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3A3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

An Open Label Study of FT218 in Subjects With Narcolepsy

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