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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02720744




Registration number
NCT02720744
Ethics application status
Date submitted
22/03/2016
Date registered
28/03/2016
Date last updated
22/03/2022

Titles & IDs
Public title
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Scientific 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
Secondary ID [1] 0 0
CLFT218-1501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive Daytime Sleepiness 0 0
Cataplexy 0 0
Narcolepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Sodium Oxybate - 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.

Placebo comparator: Placebo - 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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maintenance of Wakefulness Test (MWT)
Timepoint [1] 0 0
Study Visit 8 at 14 weeks
Primary outcome [2] 0 0
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening
Timepoint [2] 0 0
Study Visit 8 at 14 weeks
Primary outcome [3] 0 0
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline
Timepoint [3] 0 0
Visit 8 - Change from Baseline at 14 Weeks

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/03/2020
Sample size
Target
Accrual to date
Final
212
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
NHMRC CEntre for Translational Sleep and Circadian Neurobiology - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital - Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [6] 0 0
Melbourne Sleep Disorders Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2037 - Sydney
Recruitment postcode(s) [2] 0 0
NSW 2145 - Sydney
Recruitment postcode(s) [3] 0 0
QLD 4102 - Brisbane
Recruitment postcode(s) [4] 0 0
SA 5011 - Adelaide
Recruitment postcode(s) [5] 0 0
SA 5042 - Adelaide
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Pennsylvania
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South Carolina
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United States of America
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Texas
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Canada
State/province [20] 0 0
Alberta
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Canada
State/province [21] 0 0
British Columbia
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Canada
State/province [22] 0 0
Ontario
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Canada
State/province [23] 0 0
Quebec
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Czechia
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Praha
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France
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Grenoble
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France
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Montpellier
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France
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Paris
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Germany
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Berlin
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Germany
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Schwalmstadt
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Germany
State/province [30] 0 0
Schwerin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Avadel
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02720744