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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02720744
Ethics application status
Date submitted
22/03/2016
Date registered
25/03/2016
Date last updated
28/01/2019

Titles & IDs
Public title
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
Treatment: Drugs - Sodium Oxybate
Treatment: Drugs - Placebo

Experimental: Sodium Oxybate - Patients will undergo a screening period and will then be titrated to the following daily 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 daily doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo.


Treatment: Drugs: Sodium Oxybate


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Longer MWT sleep latency - MWT is the mean latency across 5 naps, averaged over the test day
Timepoint [1] 0 0
13 weeks
Primary outcome [2] 0 0
Improvement in CGI sleepiness scores - Clinician's global impression of improvement in daytime sleepiness from screening
Timepoint [2] 0 0
13 weeks
Primary outcome [3] 0 0
Fewer cataplexy attacks as recorded by Sleep and Symptom Daily Diary - Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
Timepoint [3] 0 0
13 weeks
Secondary outcome [1] 0 0
Fewer PSG transitions from N1, N2, N3, and REM sleep to wake sleep and from N2, N3, and REM sleep to N1 - Tested as part of the step down procedure based on the same statistical model used for the primary outcome measure
Timepoint [1] 0 0
13 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 or NT2 as, in part, determined by an
overnight PSG and next-day MSLT with 2 or more SOREMPs 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 as defined by subject report for the last 3 months
and an ESS > 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
Gender
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 and serotonin and norepinephrine re-uptake inhibitors (SNRIs)

4. MAOIs

5. TCAs

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
NHMRC CEntre for Translational Sleep and Circadian Neurobiology - Sydney
Recruitment hospital [2] 0 0
Melbourne Sleep Disorders Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2037 - Sydney
Recruitment postcode(s) [2] 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
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Arizona
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Arkansas
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California
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Missouri
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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United States of America
State/province [19] 0 0
Texas
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Canada
State/province [20] 0 0
Alberta
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Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha
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Finland
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Helsinki
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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
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Schwerin
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Switzerland
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Barmelweid
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Switzerland
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Bern
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Switzerland
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Lugano
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United Kingdom
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Cambridge
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United Kingdom
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Liverpool
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United Kingdom
State/province [37] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Flamel Ireland Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether FT218 is safe and effective for the
treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Trial website
https://clinicaltrials.gov/show/NCT02720744
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
Siobhan O'Daly
Address 0 0
Country 0 0
Phone 0 0
+353 1 4851210
Fax 0 0
Email 0 0
clinicaltrials@flamel.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable