A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alkermes Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Alkermes, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To evaluate the efficacy of ALKS 2680 for the treatment of excessive daytime sleepiness (EDS) in narcolepsy in participants with Narcolepsy Type 1 (NT1)

Secondary objectives 3

1. To evaluate the efficacy of ALKS 2680 for the treatment of EDS in participants with NT1
2. To evaluate the efficacy of ALKS 2680 for the treatment of cataplexy in subjects with NT1
3. To evaluate the effects of ALKS 2680 on fatigue in participants with NT1

Conditions and MedDRA coding

Narcolepsy Type 1

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Is 18 to 70 years of age at the time of informed consent.
2. Is willing and able to provide informed consent before study participation, as required by local regulations and IEC requirements.
3. Has a body mass index ≥18 and ≤40 kg/m2 at Visit 1.
4. In the opinion of the Investigator is experiencing an unsatisfactory clinical response and/or side effect(s) from any medications prescribed for the management of narcolepsy symptoms (including EDS), and can safely discontinue any medications for the duration of study and adhere to the respective washout periods
5. Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: a. Lifestyle considerations and restrictions b. Adherence to contraception guidance
6. Is willing and able to adhere to actigraphy, cataplexy diary, and sleep diary requirements during Screening.
7. If receiving treatment for obstructive sleep apnea (OSA), adherence to primary OSA therapy over the 30 days prior to Visit 1, as confirmed by the Investigator, and throughout the study, including during overnight visits. Adherence is defined in the protocol.

Exclusion criteria 14

1. Has poorly controlled and clinically significant sleep-disordered breathing, at the most recent diagnostic sleep assessment or at Visit 4 (in accordance with the American Academy of Sleep Medicine (AASM) Scoring Manual [rule 1B]): a. Has apnea-hypopnea index ≥15 per hour. b. If receiving treatment for OSA, has an average apnea-hypopnea index ≥10 per hour over the 30 days prior to Visit 1. c. Has central apnea index >5 per hour.
2. Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle as detailed in the Protocol
3. Has a significant cardiovascular disease during the Screening Period, or within 2 years prior to Visit 1, as detailed in the Protocol
4. Has a major psychiatric or substance use disorder established in accordance with Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), as detailed in the Protocol
5. Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant’s ability to complete the study. This includes but is not necessarily limited to another significant neurological disorder, including dementia, neurodegenerative disorders, stroke, or seizures (excluding isolated pediatric febrile seizures).
6. Has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (ie, a history of malabsorption or any surgical intervention). Any history of Roux-en-Y gastric bypass and any other gastric surgical intervention that may influence the absorption of drugs is considered exclusionary.
7. Has a history of cancer (treated or untreated) in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without the need for further treatment, or basal cell cancer; these participants may be included after approval by the Sponsor or designee).
8. Has known risk (eg, occludable narrow anterior chamber angle) or history of narrow-angle glaucoma.
9. Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Visit 4.
10. Presence of laboratory abnormalities at Visit 1 as detailed in the Protocol
11. Is currently taking or has taken in the last 6 months antidepressant medications for any reason other than cataplexy control. Anti-cataplexy medications will be washed-out during the Screening Period.
12. Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.
13. Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.
14. Is employed by Alkermes, the CRO, or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (ie, a spouse, parent, sibling, or child, whether biological or legally adopted) of an Alkermes, CRO, or study site employee.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in Epworth Sleepiness Scale from baseline to Week 12 by dose level

Secondary endpoints 3

1. Change in mean sleep latency on Maintenance of Wakefulness Test from baseline to Week 12 by dose level
2. Weekly cataplexy rate (WCR) at Week 12 by dose level
3. Change in select patient-reported outcome measures from baseline to Week 12 by dose level

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alkermes Inc.

Sponsor organisation

Alkermes Inc.

Address

900 Winter Street

City

Waltham

Postcode

02451-1449

Country

United States

Scientific contact point

Organisation

Alkermes Inc.

Contact name

ALKS Project Lead

Public contact point

Organisation

Alkermes Inc.

Contact name

ALKS Project Lead

Third parties 15

Locations

4 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 41 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications