ALKS 2680 for Narcolepsy
(Vibrance-2 Trial)
Recruiting in Palo Alto (17 mi)
+30 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Alkermes, Inc.
Disqualifiers: Other sleep, cardiovascular, psychiatric, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications prescribed for managing narcolepsy symptoms for at least 14 days before the study and throughout its duration.
Eligibility Criteria
This trial is for individuals with narcolepsy type 2. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.Inclusion Criteria
I often feel very sleepy during the day.
Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines
I can stop my narcolepsy medications for at least 14 days for the study.
+3 more
Exclusion Criteria
Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive ALKS 2680 or placebo tablets daily to evaluate safety and decrease in sleepiness
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Participant Groups
The trial is testing ALKS 2680 tablets against placebo tablets to see if they're safe and can reduce sleepiness in people with narcolepsy type 2.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: ALKS 2680, 18 mgExperimental Treatment1 Intervention
Oral tablet containing 18mg of ALKS 2680 for once daily administration
Group II: ALKS 2680, 14 mgExperimental Treatment1 Intervention
Oral tablet containing 14mg of ALKS 2680 for once daily administration
Group III: ALKS 2680, 10 mgExperimental Treatment1 Intervention
Oral tablet containing 10mg of ALKS 2680 for once daily administration
Group IV: PlaceboPlacebo Group1 Intervention
Oral tablet containing matching placebo for once daily administration
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Alkermes Investigator SiteAtlanta, GA
Alkermes Investigator SiteDenver, NC
Alkermes Investigator SiteHuntersville, NC
Alkermes Investigator SiteCincinnati, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Alkermes, Inc.Lead Sponsor