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Sodium Oxybate Formulation

FT218 for Narcolepsy (RESTORE Trial)

Phase 3
Waitlist Available
Research Sponsored by Avadel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

RESTORE Trial Summary

This trial is testing a new, once-nightly formulation of sodium oxybate (FT218) for the treatment of narcolepsy. The goal is to evaluate the long-term safety and tolerability of FT218 and the ability to switch from the current twice-nightly immediate release sodium oxybate to once-nightly FT218.

Eligible Conditions
  • Narcolepsy
  • Excessive Daytime Sleepiness
  • Cataplexy
  • Sleep Wake Disorder
  • Sleep Disorders
  • Sleep Disorder

RESTORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of clinically significant changes in laboratory test results
Incidence of clinically significant changes in vital signs
Incidence of treatment-related adverse events

Side effects data

From 2020 Phase 3 trial • 212 Patients • NCT02720744
9%
Enuresis
5%
Vomiting
5%
Dizziness
4%
Somnolence
4%
Headache
4%
Weight Decreased
4%
Nausea
3%
Decreased Appetite
3%
Nasopharyngitis
1%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo 9g Group
FT218 9g Group

RESTORE Trial Design

1Treatment groups
Experimental Treatment
Group I: FT218Experimental Treatment1 Intervention
once nightly sodium oxybate extended release oral solution (FT218)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FT218
2020
Completed Phase 3
~400

Find a Location

Who is running the clinical trial?

AvadelLead Sponsor
1 Previous Clinical Trials
212 Total Patients Enrolled
1 Trials studying Narcolepsy
212 Patients Enrolled for Narcolepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients who want to enroll in this trial?

"According to the data available on clinicaltrials.gov, this specific trial is no longer recruiting patients. The trial's initial posting date was June 12th 2020 and it was last edited on June 10th 2022. There are, however, 1117 other trials that are actively seeking patients right now."

Answered by AI

In how many different geographical areas is this trial being conducted?

"To make participating as easy as possible for enrollees, this trial is being conducted at 23 sites around the country. A few of these locations include Boulder, Springfield and Winter Park."

Answered by AI

Does FT218 have the green light from the FDA?

"FT218 has received a score of 3 from our team at Power. This is because it is a Phase 3 trial, which means that while there is data supporting efficacy, multiple rounds of data also support safety."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Tennessee
Other
Texas
How old are they?
18 - 65
What site did they apply to?
SDS Clinical Trials
FutureSearch Trials of Neurology
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
An Open Label Study of FT218 in Subjects With Narcolepsy
2020. "An Open Label Study of FT218 in Subjects With Narcolepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04451668.
~38 spots leftby Apr 2025
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