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8 mg ALKS 2680 for Narcolepsy (Vibrance-1 Trial)

Phase 2

Recruiting

Research Sponsored by Alkermes, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at week 5 and 6

Awards & highlights

Vibrance-1 Trial Summary

This trial aims to test if ALKS 2680 is safe and effective in reducing sleepiness and cataplexy compared to a placebo.

Who is the study for?

This trial is for individuals with Narcolepsy Type 1, a condition causing excessive daytime sleepiness and sometimes sudden muscle weakness. Participants should be diagnosed with this type of narcolepsy to qualify.Check my eligibility

What is being tested?

The study tests ALKS 2680 against a placebo to see if it better reduces sleepiness and cataplexy in people with Narcolepsy Type 1. It's designed to compare the effects of the drug versus no active treatment.See study design

What are the potential side effects?

Possible side effects of ALKS 2680 are not detailed here but typically could include headache, nausea, dizziness, or insomnia. Placebo generally has no side effects since it contains no active medication.

Vibrance-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at week 5 and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at week 5 and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at week 5 and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6

Secondary outcome measures

Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6

Incidence of adverse events

Mean weekly cataplexy rate (WCR) as derived by subject cataplexy

Vibrance-1 Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 8 mg ALKS 2680Experimental Treatment1 Intervention

Group II: 6 mg ALKS 2680Experimental Treatment1 Intervention

Group III: 4 mg ALKS 2680Experimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor

114 Previous Clinical Trials

26,808 Total Patients Enrolled

Study Medical Director, MDStudy DirectorAlkermes, Inc.

Frequently Asked Questions

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

Are individuals above the age of 20 eligible to participate in this ongoing medical study?

"Individuals must be at least 18 years old but not older than 70 to qualify for participation in this clinical trial as per the eligibility criteria."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"To qualify for this research study, potential participants must have a medical history of narcolepsy and fall within the age bracket of 18 to 70 years. The trial aims to enroll a total of 80 individuals."

Answered by AI

What is the total number of subjects actively involved in this research investigation?

"Indeed, the details on clinicaltrials.gov confirm that this particular research study is actively enrolling volunteers. Originally shared on March 28th, 2024, with the latest update made on April 5th, 2024, this trial aims to recruit a total of 80 participants from a single designated site."

Answered by AI

Are there still opportunities for individuals to enroll in this ongoing study?

"Indeed, details on clinicaltrials.gov highlight the ongoing recruitment of participants for this specific clinical trial. The initial posting date was 28th March 2024, with the most recent update made on 5th April 2024. This study aims to enroll a total of 80 individuals at one designated site."

Answered by AI

What are the potential risks associated with an 8 mg dose of ALKS 2680 for individuals?

"Based on our evaluation at Power, the safety rating for 8 mg of ALKS 2680 is a level 2. This assessment stems from it being in Phase 2 where there exists some data backing its safety but none confirming efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1

2024. "A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06358950.

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