Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

Narcolepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720744
• Other study ID #: CLFT218-1501
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2016
• Est. completion date: March 25, 2020

Study information

• Verified date: March 2022
• Source: Avadel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects 16 years of age or older

2. 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

3. 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.

4. 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

5. For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months

6. Subjects may use concomitant stimulants, but must comply with the following:

1. They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND

2. They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods

3. They must discontinue all anti cataplexy drugs

7. Addition inclusion criteria per protocol

Exclusion criteria

1. Any prior use of sodium oxybate is allowed in the study but within the following exclusions:

1. Previous dosing must have been limited to no more than 4.5g per night

2. Patient should not have taken sodium oxybate for more than 2 weeks.

3. All previous dosing must not have occurred within the last year prior to entry to the study.

2. Current use of sodium valproate

3. Any use of the following prohibited medications for the duration of the clinical study:

1. Anticonvulsants

2. Clonidine

3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine re-uptake inhibitors (SNRIs)

4. MAOIs (monoamine oxidase inhibitors)

5. TCAs (tricyclic antidepressants)

6. Hypnotics

7. Anxiolytics

8. Sedating antihistamines

9. Antipsychotics

10. Other experimental medications designed to treat narcolepsy, cataplexy or any other condition

4. Treatment with any investigational products within 3 months before study enrollment

5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted

6. Additional exclusion criteria per protocol

Related Conditions & MeSH terms

• Cataplexy
• Disorders of Excessive Somnolence
• Excessive Daytime Sleepiness
• Narcolepsy
• Sleepiness

Intervention

Drug:
• FT218

• Placebo

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Queen Elizabeth Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Melbourne Sleep Disorders Centre	Melbourne	Victoria
Australia	NHMRC CEntre for Translational Sleep and Circadian Neurobiology	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales
Canada	Somni Research Inc. Calgary	Calgary	Alberta
Canada	Okanagan Clinical Trials Ltd	Kelowna	British Columbia
Canada	CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal	Montreal	Quebec
Canada	West Parry Sound Health Center	Parry Sound	Ontario
Canada	Paediatric Sleep Research Inc	Toronto	Ontario
Canada	Somni Research Inc	Toronto	Ontario
Czechia	Vseobecna Facultni Nemocnice	Praha
France	CHU Michallon	Grenoble
France	Hospital Gui-de-de-Chauliac	Montpellier
France	INSERM - Centre d'Investigation Clinque Hopital Robert Debre	Paris
Germany	Charit Universittsmedizin Berlin	Berlin
Germany	Hephata Klinik	Schwalmstadt
Germany	Somni bene GmbH	Schwerin
United States	California Center for Sleep Disorders	Alameda	California
United States	Pinnacle Research Group LLC	Anniston	Alabama
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	University Sleep Disorder Center	Auburn	Alabama
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	Alpine Research Center	Boulder	Colorado
United States	Montefiore Sleep-Wake Disorders Center	Bronx	New York
United States	Medical University of South Carolina - Institute of Psychiatry	Charleston	South Carolina
United States	Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	Sleep Management Institute Intrepid Research	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	SleepMed Of South Carolina	Columbia	South Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Ohio Sleep Medicine Institute	Dublin	Ohio
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Sleep and Neurology Consultants	Houston	Texas
United States	Research Carolina of Huntersville	Huntersville	North Carolina
United States	Pulmonary Disease Specialist, PA	Kissimmee	Florida
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Norton Clinical Research Group	Louisville	Kentucky
United States	Sleep Medicine Specialist of South Florida	Miami	Florida
United States	Sleep Medicine Specialists of South Florida	Miami	Florida
United States	Northwell Health	New Hyde Park	New York
United States	Clinilabs Drug Development Corporation	New York	New York
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	Yale-New Haven Hospital's Sleep Medicine Center	North Haven	Connecticut
United States	NeuroMedical Research Institute/Global Research Holdings, LLC	Panama City	Florida
United States	OSF Healthcare Saint Francis Medical Center	Peoria	Illinois
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Stanford Sleep Medicine	Redwood City	California
United States	Sleep Therapy Research Center	San Antonio	Texas
United States	SDS Clinical Trials Inc	Santa Ana	California
United States	Clinical Research Institute	Stockbridge	Georgia
United States	FL Pediatric REsearch Institute	Winter Park	Florida
United States	Florida Pulmonary Research Institute LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Avadel

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of Wakefulness Test (MWT)	Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day	Study Visit 8 at 14 weeks
Primary	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	Study Visit 8 at 14 weeks
Primary	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	Visit 8 - Change from Baseline at 14 Weeks