NCT06767683 A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
| NCT ID | NCT06767683 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Alkermes, Inc. |
| Condition | Narcolepsy Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 256 participants in total. It began in 2025-01-27 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Eligibility Criteria
Inclusion Criteria: * Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3) * Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects) Exclusion Criteria: * Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study * Is currently pregnant, breastfeeding, or planning to become pregnant during the study * Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening
Contact & Investigator
Medical Director
STUDY DIRECTOR
Alkermes, Inc.
Frequently Asked Questions
Who can join the NCT06767683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Narcolepsy Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06767683 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06767683 currently recruiting?
Yes, NCT06767683 is actively recruiting participants. Contact the research team at clinicaltrials@alkermes.com for enrollment information.
Where is the NCT06767683 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Los Angeles, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT06767683 clinical trial?
NCT06767683 is sponsored by Alkermes, Inc.. The principal investigator is Medical Director at Alkermes, Inc.. The trial plans to enroll 256 participants.