ALKS 2680 for Narcolepsy Type 1 | Narcolepsy Type 2 | Idiopathic hypersomnia

Inclusion criteria

• {"criterion_text":"- Is willing and able to provide informed consent before study participation, as required by local regulations and IEC requirements."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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.\tSignificant cardiovascular disease e.\tMajor psychiatric or substance use disorder"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Screening. See Section 10.2 for details."}
• {"criterion_text":"- 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%"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Is currently pregnant, breastfeeding, or planning to become pregnant during the study."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Clinical laboratory assessments","definition_or_measurement_approach":"Standard clinical laboratory safety assessments (laboratory tests as per protocol)."}
• {"endpoint_text":"- Vital signs","definition_or_measurement_approach":"Standard vital sign measurements (e.g., blood pressure, heart rate) per schedule."}
• {"endpoint_text":"- Safety electrocardiogram (ECG)","definition_or_measurement_approach":"Safety ECG recordings as specified in the protocol."}
• {"endpoint_text":"- Columbia-Suicide Severity Rating Scale (C-SSRS)","definition_or_measurement_approach":"Assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)."}
• {"endpoint_text":"- Change in the MSL on MWT from baseline to Week 24 (for NT1 and NT2 subjects only)","definition_or_measurement_approach":"Measured as change in Multiple Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 24."}
• {"endpoint_text":"- Change in Epworth Sleepiness Scale (ESS) from baseline through the Treatment Period","definition_or_measurement_approach":"Measured by change in Epworth Sleepiness Scale (ESS) score from baseline through treatment."}
• {"endpoint_text":"- Change in the weekly cataplexy rate (WCR) from baseline through the Treatment Period (for NT1 subjects only)","definition_or_measurement_approach":"Measured as change in weekly cataplexy rate (WCR) from baseline through the treatment period."}
• {"endpoint_text":"- Change in IHSS from baseline through the Treatment Period (for IH subjects only)","definition_or_measurement_approach":"Measured by change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline through treatment."}

Belgium

Earliest CTIS Part Ii Submission Date

04-04-2025

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

304

Number Of Sites

3

Number Of Participants

25

Czechia

Earliest CTIS Part Ii Submission Date

25-02-2025

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

343

Number Of Sites

1

Number Of Participants

15

France

Earliest CTIS Part Ii Submission Date

17-03-2025

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

326

Number Of Sites

3

Number Of Participants

12

Italy

Earliest CTIS Part Ii Submission Date

14-04-2025

Latest Decision Or Authorization Date

04-02-2026

Processing Time Days

296

Number Of Sites

3

Number Of Participants

32

Spain

Earliest CTIS Part Ii Submission Date

08-04-2025

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

304

Number Of Sites

3

Number Of Participants

45

Netherlands

Earliest CTIS Part Ii Submission Date

24-04-2025

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

285

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Alkermes Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

codes: 1,10,12,14,2,5,6

Name

Eresearchtechnology Inc.

Responsibilities

ECG (code:15)

Name

Suvoda LLC

Responsibilities

code:3

Name

Q Squared Solutions Limited

Responsibilities

code:4

Name

Medidata Solutions Inc.

Responsibilities

code:7

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes: 1,10,12,14,2,5,6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG (code:15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject Reimbursement (code:15)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Clinilabs Inc.","duties_or_roles":"EEG/PSG (code:15)","organisation_type":"Pharmaceutical company"}