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

March 18, 2022 updated by: Avadel

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2037
        • NHMRC CEntre for Translational Sleep and Circadian Neurobiology
      • Sydney, New South Wales, Australia, NSW 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, QLD 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, SA 5011
        • Queen Elizabeth Hospital
      • Adelaide, South Australia, Australia, SA 5042
        • Flinders Medical Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Melbourne Sleep Disorders Centre
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2X 2A8
        • Somni Research Inc. Calgary
    • British Columbia
      • Kelowna, British Columbia, Canada, BC V1Y 1Z9
        • Okanagan Clinical Trials Ltd
    • Ontario
      • Parry Sound, Ontario, Canada, P2A 3A4
        • West Parry Sound Health Center
      • Toronto, Ontario, Canada, L3R 1A3
        • Somni Research Inc
      • Toronto, Ontario, Canada, M5G 1N8
        • Paediatric Sleep Research Inc
    • Quebec
      • Montreal, Quebec, Canada, 5400
        • CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal
  • Czechia
      • Praha, Czechia, 212821
        • Vseobecna Facultni Nemocnice
  • France
      • Grenoble, France, 938043
        • CHU Michallon
      • Montpellier, France, 34295
        • Hospital Gui-de-de-Chauliac
      • Paris, France, 75019
        • INSERM - Centre d'Investigation Clinque Hopital Robert Debre
  • Germany
      • Berlin, Germany, 10117
        • Charit Universittsmedizin Berlin
      • Schwalmstadt, Germany, 34131
        • Hephata Klinik
      • Schwerin, Germany, 19053
        • Somni Bene GmbH
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group LLC
      • Auburn, Alabama, United States, AL 36832
        • University Sleep Disorder Center
      • Birmingham, Alabama, United States, 35213
        • Sleep Disorders Center of Alabama
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Center for Clinical Research
    • California
      • Alameda, California, United States, 94501
        • California Center for Sleep Disorders
      • Redwood City, California, United States, 94063
        • Stanford Sleep Medicine
      • Santa Ana, California, United States, CA 92705
        • SDS Clinical Trials Inc
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Alpine Research Center
    • Connecticut
      • North Haven, Connecticut, United States, 06473
        • Yale-New Haven Hospital's Sleep Medicine Center
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Pulmonary Disease Specialist, PA
      • Miami, Florida, United States, 33176
        • Sleep Medicine Specialists of South Florida
      • Miami, Florida, United States, FL 33126
        • Sleep Medicine Specialist of South Florida
      • Panama City, Florida, United States, FL 32405
        • NeuroMedical Research Institute/Global Research Holdings, LLC
      • Winter Park, Florida, United States, 32789
        • FL Pediatric Research Institute
      • Winter Park, Florida, United States, 32789
        • Florida Pulmonary Research Institute LLC
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Neurotrials Research Inc
      • Atlanta, Georgia, United States, GA 30342
        • Sleep Disorders Center of Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Institute
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF HealthCare Saint Francis Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, IN 46804
        • Fort Wayne Neurological Center
    • Kentucky
      • Louisville, Kentucky, United States, KY40218
        • Norton Clinical Research Group
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Center For Sleep and Wake Disorders
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, MA 2747
        • Infinity Medical Research
    • Missouri
      • Chesterfield, Missouri, United States, 63017
      • Saint Louis, Missouri, United States, 63143
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Sleep-Wake Disorders Center
      • New Hyde Park, New York, United States, NY 1040
        • Northwell Health
      • New York, New York, United States, NY10019
        • Clinilabs Drug Development Corporation
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Research Carolina of Huntersville
      • Raleigh, North Carolina, United States, NC 27612
        • Wake Research Associates, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Sleep Management Institute Intrepid Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Dublin, Ohio, United States, 43017
        • Ohio Sleep Medicine Institute
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, SC 29425
        • Medical University of South Carolina - Institute of Psychiatry
      • Columbia, South Carolina, United States, 29201
        • Sleepmed of South Carolina
    • Texas
      • Houston, Texas, United States, 77063
        • Sleep and Neurology Consultants
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Study Visit 8 at 14 weeks
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
Study Visit 8 at 14 weeks
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
Visit 8 - Change from Baseline at 14 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avadel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLFT218-1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings