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

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ClinicalTrials.gov Identifier: NCT02720744
Recruitment Status : Completed
First Posted : March 28, 2016
Results First Posted : March 22, 2022
Last Update Posted : March 22, 2022
Sponsor:
Information provided by (Responsible Party):
Avadel

Study Description
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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.

Condition or disease Intervention/treatment Phase
Excessive Daytime Sleepiness Cataplexy Narcolepsy Drug: FT218 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 17, 2016
Actual Primary Completion Date : March 25, 2020
Actual Study Completion Date : March 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: FT218
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.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Maintenance of Wakefulness Test (MWT) [ Time Frame: Study Visit 8 at 14 weeks ]
    Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day

  2. Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening [ Time Frame: Study Visit 8 at 14 weeks ]
    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

  3. Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline [ Time Frame: Visit 8 - Change from Baseline at 14 Weeks ]
    Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720744


Locations
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Sponsors and Collaborators
Avadel
  Study Documents (Full-Text)

Documents provided by Avadel:
Study Protocol  [PDF] August 1, 2019
Statistical Analysis Plan  [PDF] July 31, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Avadel
ClinicalTrials.gov Identifier: NCT02720744    
Other Study ID Numbers: CLFT218-1501
First Posted: March 28, 2016    Key Record Dates
Results First Posted: March 22, 2022
Last Update Posted: March 22, 2022
Last Verified: March 2022
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Cataplexy
Sleepiness
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders