NCT06767683 · Alkermes, Inc.
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
ALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
DRUG
ALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
DRUG
ALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
DRUG
ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
DRUG
ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
DRUG
ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 100 Weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Little Rock, Arkansas
- Los Angeles, California
- San Francisco, California
- Stanford, California
- Colorado Springs, Colorado
- Brandon, Florida
- Miami, Florida
- Winter Park, Florida
- Atlanta, Georgia
- Macon, Georgia
- Stockbridge, Georgia
And 17 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations