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

Avadel Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cataplexy; Excessive Daytime Sleepiness; Narcolepsy

Treatments: Drug: FT218; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02720744

CLFT218-1501

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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212 participants in 2 patient groups, including a placebo group

Sodium Oxybate

Experimental group

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.

Treatment:

Drug: FT218

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo