Back to resultsOnce-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Primary Purpose
Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FT218
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Excessive Daytime Sleepiness
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects 16 years of age or older
- Willing and able to give written informed consent for study participation. For young adults (16 and 17 years old) who have not reached the age of majority they must be capable of giving assent and consent from a legally authorized guardian must be obtained, as required by local laws and regulations
- Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2 narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
- Current continuing presence of EDS (excessive daytime sleepiness) as defined by subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
- For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months
Subjects may use concomitant stimulants, but must comply with the following:
- They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND
- They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods
- They must discontinue all anti cataplexy drugs
- Addition inclusion criteria per protocol
Exclusion criteria
Any prior use of sodium oxybate is allowed in the study but within the following exclusions:
- Previous dosing must have been limited to no more than 4.5g per night
- Patient should not have taken sodium oxybate for more than 2 weeks.
- All previous dosing must not have occurred within the last year prior to entry to the study.
- Current use of sodium valproate
Any use of the following prohibited medications for the duration of the clinical study:
- Anticonvulsants
- Clonidine
- SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
- MAOIs (monoamine oxidase inhibitors)
- TCAs (tricyclic antidepressants)
- Hypnotics
- Anxiolytics
- Sedating antihistamines
- Antipsychotics
- Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
- Treatment with any investigational products within 3 months before study enrollment
- Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
- Additional exclusion criteria per protocol
Sites / Locations
- Pinnacle Research Group LLC
- University Sleep Disorder Center
- Sleep Disorders Center of Alabama
- Baptist Health Center for Clinical Research
- California Center for Sleep Disorders
- Stanford Sleep Medicine
- SDS Clinical Trials Inc
- Alpine Research Center
- Yale-New Haven Hospital's Sleep Medicine Center
- Pulmonary Disease Specialist, PA
- Sleep Medicine Specialists of South Florida
- Sleep Medicine Specialist of South Florida
- NeuroMedical Research Institute/Global Research Holdings, LLC
- FL Pediatric REsearch Institute
- Florida Pulmonary Research Institute LLC
- NeuroTrials Research Inc
- Sleep Disorders Center of Georgia
- Clinical Research Institute
- OSF Healthcare Saint Francis Medical Center
- Fort Wayne Neurological Center
- Norton Clinical Research Group
- Center for Sleep and Wake Disorders
- Infinity Medical Research
- Montefiore Sleep-Wake Disorders Center
- Northwell Health
- Clinilabs Drug Development Corporation
- Research Carolina of Huntersville
- Wake Research Associates, LLC
- Sleep Management Institute Intrepid Research
- University Hospitals Case Medical Center
- Ohio Sleep Medicine Institute
- Geisinger Medical Center
- Medical University of South Carolina - Institute of Psychiatry
- SleepMed Of South Carolina
- Sleep and Neurology Consultants
- Sleep Therapy Research Center
- NHMRC CEntre for Translational Sleep and Circadian Neurobiology
- Westmead Hospital
- Princess Alexandra Hospital
- Queen Elizabeth Hospital
- Flinders Medical Centre
- Melbourne Sleep Disorders Centre
- Somni Research Inc. Calgary
- Okanagan Clinical Trials Ltd
- West Parry Sound Health Center
- Somni Research Inc
- Paediatric Sleep Research Inc
- CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal
- Vseobecna Facultni Nemocnice
- CHU Michallon
- Hospital Gui-de-de-Chauliac
- INSERM - Centre d'Investigation Clinque Hopital Robert Debre
- Charit Universittsmedizin Berlin
- Hephata Klinik
- Somni bene GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium Oxybate
Placebo
Arm Description
Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate.
Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo.
Outcomes
Primary Outcome Measures
Maintenance of Wakefulness Test (MWT)
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening
The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02720744
Brief Title
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Official Title
A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 17, 2016 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avadel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Oxybate
Arm Type
Experimental
Arm Description
Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo.
Intervention Type
Drug
Intervention Name(s)
FT218
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Maintenance of Wakefulness Test (MWT)
Description
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
Time Frame
Study Visit 8 at 14 weeks
Title
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening
Description
The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Time Frame
Study Visit 8 at 14 weeks
Title
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline
Description
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
Time Frame
Visit 8 - Change from Baseline at 14 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 16 years of age or older
Willing and able to give written informed consent for study participation. For young adults (16 and 17 years old) who have not reached the age of majority they must be capable of giving assent and consent from a legally authorized guardian must be obtained, as required by local laws and regulations
Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2 narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with mean sleep latency in the pathological range i.e. < 8 minutes and meeting the NT1 and NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
Current continuing presence of EDS (excessive daytime sleepiness) as defined by subject report for the last 3 months and an ESS (Epworth sleepiness scale) > 10
For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months
Subjects may use concomitant stimulants, but must comply with the following:
They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND
They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods
They must discontinue all anti cataplexy drugs
Addition inclusion criteria per protocol
Exclusion criteria
Any prior use of sodium oxybate is allowed in the study but within the following exclusions:
Previous dosing must have been limited to no more than 4.5g per night
Patient should not have taken sodium oxybate for more than 2 weeks.
All previous dosing must not have occurred within the last year prior to entry to the study.
Current use of sodium valproate
Any use of the following prohibited medications for the duration of the clinical study:
Anticonvulsants
Clonidine
SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
MAOIs (monoamine oxidase inhibitors)
TCAs (tricyclic antidepressants)
Hypnotics
Anxiolytics
Sedating antihistamines
Antipsychotics
Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
Treatment with any investigational products within 3 months before study enrollment
Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
Additional exclusion criteria per protocol
Facility Information:
Facility Name
Pinnacle Research Group LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
University Sleep Disorder Center
City
Auburn
State/Province
Alabama
ZIP/Postal Code
AL 36832
Country
United States
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
California Center for Sleep Disorders
City
Alameda
State/Province
California
ZIP/Postal Code
94501
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 Inc
City
Santa Ana
State/Province
California
ZIP/Postal Code
CA 92705
Country
United States
Facility Name
Alpine Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Yale-New Haven Hospital's Sleep Medicine Center
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Pulmonary Disease Specialist, 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
Sleep Medicine Specialist of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
FL 33126
Country
United States
Facility Name
NeuroMedical Research Institute/Global Research Holdings, LLC
City
Panama City
State/Province
Florida
ZIP/Postal Code
FL 32405
Country
United States
Facility Name
FL Pediatric REsearch Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Florida Pulmonary Research Institute LLC
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
30342
Country
United States
Facility Name
Sleep Disorders Center of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
GA 30342
Country
United States
Facility Name
Clinical Research Institute
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
OSF Healthcare Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
IN 46804
Country
United States
Facility Name
Norton Clinical Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
KY40218
Country
United States
Facility Name
Center for Sleep and Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Infinity Medical Research
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
MA 2747
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
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
Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
NY 1040
Country
United States
Facility Name
Clinilabs Drug Development Corporation
City
New York
State/Province
New York
ZIP/Postal Code
NY10019
Country
United States
Facility Name
Research Carolina of Huntersville
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
NC 27612
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 Case 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
Medical University of South Carolina - Institute of Psychiatry
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
SC 29425
Country
United States
Facility Name
SleepMed Of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Sleep and Neurology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Sleep Therapy Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NHMRC CEntre for Translational Sleep and Circadian Neurobiology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
QLD 4102
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
SA 5011
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
SA 5042
Country
Australia
Facility Name
Melbourne Sleep Disorders Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Somni Research Inc. Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2X 2A8
Country
Canada
Facility Name
Okanagan Clinical Trials Ltd
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
BC V1Y 1Z9
Country
Canada
Facility Name
West Parry Sound Health Center
City
Parry Sound
State/Province
Ontario
ZIP/Postal Code
P2A 3A4
Country
Canada
Facility Name
Somni Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
L3R 1A3
Country
Canada
Facility Name
Paediatric Sleep Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Facility Name
CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
5400
Country
Canada
Facility Name
Vseobecna Facultni Nemocnice
City
Praha
ZIP/Postal Code
212821
Country
Czechia
Facility Name
CHU Michallon
City
Grenoble
ZIP/Postal Code
938043
Country
France
Facility Name
Hospital Gui-de-de-Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
INSERM - Centre d'Investigation Clinque Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Charit Universittsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Hephata Klinik
City
Schwalmstadt
ZIP/Postal Code
34131
Country
Germany
Facility Name
Somni bene GmbH
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
35380374
Citation
Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D. Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial. CNS Drugs. 2022 Apr;36(4):377-387. doi: 10.1007/s40263-022-00904-6. Epub 2022 Apr 5.
Results Reference
derived
PubMed Identifier
34358324
Citation
Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, Dauvilliers Y. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022 Jun 13;45(6):zsab200. doi: 10.1093/sleep/zsab200.
Results Reference
derived
Learn more about this trial
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
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