A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

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]

Trial duration

14 May 2025 → ongoing

Decision date (initial)

2025-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Alkermes Inc.

External identifiers

EU CT number

2024-519822-18-00

ClinicalTrials.gov

NCT06767683

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the safety and tolerability of ALKS 2680 in subjects with narcolepsy or IH

Secondary objectives 2

1. To evaluate the safety and tolerability of ALKS 2680 in subjects with narcolepsy or IH
2. To evaluate the efficacy and durability of effect of ALKS 2680 for the treatment of excessive daytime sleepiness (EDS) in subjects with narcolepsy or IH and treatment of cataplexy in subjects with NT1

Conditions and MedDRA coding

Narcolepsy Type 1, Type 2 and Idiopathic Hypersomnia

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Is willing and able to provide informed consent before study participation, as required by local regulations and IEC requirements.
2. Was eligible for and has completed the EoT Visit of an ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible ALKS 2680 studies are ALKS 2680-201, ALKS 2680-202 and ALKS 2680-203.
3. Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: a. Certain lifestyle considerations and restrictions detailed in the Section 5.3 b. Adherence to contraception guidance (examples include but are not limited to: IUD, hormonal contraception, and condom use, as applicable). For further details, please refer to Section 10.4.2. c. Adherence to study schedule, actigraphy wear requirements, and diary completion
4. Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy or IH symptoms, including EDS and cataplexy, as applicable, for 5 half-lives prior to Day 1 (this discontinuation requirement is only applicable for re-entry subjects), and for the duration of study (for all subjects). See list of prohibited medications in Section 6.9.1. Subjects who roll over directly into the study from either ALKS 2680-201, ALKS 2680-202 or ALKS 2680-203 do not need to undergo medication discontinuation and will continue on ALKS 2680 uninterrupted.
5. In the opinion of the investigator, the subject has experienced improvement in narcolepsy symptoms during the Open Label Extension Period of an ALKS 2680 eligible parent study in NT1 or NT2 (applies to subjects coming from Parent Study ALKS 2680-201 and Parent Study ALKS 2680-202, as applicable).

Exclusion criteria 9

1. Developed a new clinically significant health condition, ECG or laboratory abnormality, or finding in the eye and vision examination during the parent study or has an anticipated eye surgery during the course of the study that, in the opinion of the Investigator or Sponsor, may impact the subject’s participation in the study.
2. Has a history or presence at Screening of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the study. This includes but is not necessarily limited to the following: a. Uncontrolled or unstable hypothyroidism or diabetes mellitus b. Clinically significant hepatic or renal disease c. Significant neurological disorder, including dementia, neurodegeneration, stroke, epilepsy, or seizures (excluding pediatric febrile seizures) d. Significant cardiovascular disease e. Major psychiatric or substance use disorder
3. Is at a current risk of suicidal behavior; or has a “Yes” to questions 4 or 5 on the C-SSRS and/or had a suicide attempt in the period within 12 months prior to Screening.
4. Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Screening. See Section 10.2 for details.
5. If a re-entry subject, presence of the following laboratory abnormalities at Screening (one repeat is allowed at the Investigator’s discretion), including: a. Elevated liver function tests (ALT, AST) >1.5 times the upper limit of normal b. Positive serology test for HbsAg or hepatitis C antibody confirmed by RNA testing at Screening c. Renal creatinine clearance (Cockcroft-Gault Equation) ≤50 mL/min d. HbA1c ≥6.5%
6. Is currently taking (or is anticipated to take) any prohibited prescription or OTC medications listed in Section 6.9.1, or will not be able to comply with provided washout requirements.
7. Is currently pregnant, breastfeeding, or planning to become pregnant during the study.
8. Is currently enrolled in another interventional clinical trial (other than the parent study) or used any investigational drug or interventional device within 30 days prior to Screening.
9. 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. Treatment-emergent adverse events (TEAEs)

Secondary endpoints 8

1. Clinical laboratory assessments
2. Vital signs
3. Safety electrocardiogram (ECG)
4. Columbia-Suicide Severity Rating Scale (C-SSRS)
5. Change in the MSL on MWT from baseline to Week 24 (for NT1 and NT2 subjects only)
6. Change in Epworth Sleepiness Scale (ESS) from baseline through the Treatment Period
7. Change in the weekly cataplexy rate (WCR) from baseline through the Treatment Period (for NT1 subjects only)
8. Change in IHSS from baseline through the Treatment Period (for IH subjects only)

Investigational products

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

Test 6

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 8

Locations

6 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 113 files

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

Application history

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