Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
96
Countries
6
Sites
13
Idiopathic Hypersomnia (IH)
To evaluate the efficacy of ALKS 2680 for the treatment of Excessive Daytime Sleepiness (EDS) in subjects with Idiopathic Hypersomnia (IH)
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
- 26 Aug 2025 → ongoing
- Decision date (initial)
- 2025-08-21
- 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
To evaluate the efficacy of ALKS 2680 for the
treatment of Excessive Daytime Sleepiness (EDS) in subjects with Idiopathic Hypersomnia (IH)
Secondary objectives 2
- To evaluate the efficacy of ALKS 2680 for the treatment of EDS in subjects with IH
- To evaluate the safety and tolerability of ALKS 2680 in subjects with IH
Conditions and MedDRA coding
Idiopathic Hypersomnia (IH)
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period Up to 4 weeks
|
Not Applicable | None | ||
| 2 | Washout period 2 weeks
|
Not Applicable | None | ||
| 3 | Treatment period Up to 8 weeks
|
Randomised Controlled | Double | [{"id":156198,"code":2,"name":"Investigator"},{"id":156199,"code":1,"name":"Subject"},{"id":156200,"code":3,"name":"Monitor"}] | 10 mg ALKS 2680: Study treatment 14 mg ALKS 2680: Study treatment 18 mg ALKS 2680: Study treatment Placebo: Control group |
| 4 | Safety Follow-up/ET/EoS 2 weeks
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: a. Lifestyle considerations and restrictions b. Adherence to contraception guidance. c. Adherence to actigraphy and diary requirements d. If receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
- Meets the diagnostic criteria of IH according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years.
Exclusion criteria 4
- Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
- Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
- 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 subject safety, interfere with any study assessment, or affect the subject’s ability to complete the study.
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level.
Secondary endpoints 2
- Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level.
- • TEAEs • Clinical laboratory assessments • Vital signs • Safety ECG • C-SSRS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD11145919 · Product
- Active substance
- Alks 2680
- Other product name
- RDC-264177, RDC-264177-00, and CMG-177BFD00
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1190 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALKERMES, INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD11446359 · Product
- Active substance
- Alks 2680
- Other product name
- RDC-264177, RDC-264177-00, and CMG-177BFD00
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 18 mg milligram(s)
- Max total dose
- 1638 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALKERMES, INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD11446358 · Product
- Active substance
- Alks 2680
- Other product name
- RDC-264177, RDC-264177-00, and CMG-177BFD00
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 14 mg milligram(s)
- Max total dose
- 1414 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALKERMES, INC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
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 14
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| American National Red Cross ORG-100045926
|
Philadelphia, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Clinilabs Inc. ORG-100048107
|
Eatontown, United States | Other |
| Signant Health Global Solutions Limited ORG-100047290
|
Dublin 2, Ireland | Other |
| Actigraph LLC ORG-100043702
|
Pensacola, United States | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Cogstate Limited ORG-100044403
|
Melbourne, Australia | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 10, Code 12, Code 14, Code 2, Code 5, Data management |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Iqvia Laboratories Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
Locations
6 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 4 | 2 |
| Czechia | Ongoing, recruiting | 1 | 1 |
| France | Ongoing, recruiting | 2 | 3 |
| Italy | Ongoing, recruiting | 3 | 3 |
| Netherlands | Ended | 2 | 1 |
| Spain | Ongoing, recruiting | 3 | 3 |
| Rest of world
Australia, United States
|
— | 81 | — |
Investigational sites
Pneumocare
Medical Research Center, Chaussee De Marche 571, 5101, Namur
Anima
Research Center, Alkerstraat 28, 3570, Alken
Vseobecna Fakultni Nemocnice V Praze
Neurologická klinika, Katerinska 468/30, Nove Mesto, Prague
Centre Hospitalier Universitaire De Bordeaux
Sleep Medicine, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Montpellier
Neurologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology/ Physiology, Sleep and Exercise, Pavillon E, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 09
Instituto Di Ricovero E Cura A Carattere Scientifico
Neurologia, Ospedale Bellaria, Via Altura 3, Bologna
Centro Ricerche Cliniche Di Verona S.r.l.
CRC, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Istituto San Raffaele
UO Neurologia-Centro di Medicina del Sonno, Via Stamira D'ancona 20, 20127, Milan
Epilepsie Instellingen Nederland Stichting
Neurology, Dokter Denekampweg 20, 8025 BV, Zwolle
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-09-18 | 2025-09-24 | |||
| Czechia | 2025-09-02 | 2025-09-11 | |||
| France | 2025-10-10 | 2025-10-23 | |||
| Italy | 2025-09-18 | 2025-10-07 | |||
| Netherlands | 2025-08-26 | 2025-09-04 | 2026-01-28 | ||
| Spain | 2025-09-23 | 2025-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 104 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-520981-23-00_red | EU 1.4 |
| Protocol (for publication) | D4_Patient-facing_ESS_BE FR_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_ESS_BE NL_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_ESS_CZ_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_ESS_EN_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_ESS_ES_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_ESS_FR_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_ESS_IT_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_ESS_NL_2025-520981-23-00 | No version |
| Protocol (for publication) | D4_Patient-facing_IHSS_BE FR_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IHSS_BE NL_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IHSS_CZ_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IHSS_EN_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IHSS_ES_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IHSS_FR_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IHSS_IT_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IHSS_NL_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_BE FR_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_BE NL_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_CZ_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_EN_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_ES_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_FR_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_IT_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_KSS_NL_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_BE FR_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_BE NL_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_CZ_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_EN_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_ES_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_FR_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_IT_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Sleep diary_NL_2025-520981-23-00 | 1 |
| Protocol (for publication) | D4_Placeholder for patient materials | No version |
| Recruitment arrangements (for publication) | K1_2025-520981-23-00_Recruitement Arrangements_FRA_San | 1.0 |
| Recruitment arrangements (for publication) | K1_ALKS 2680-203_Recruitment and Informed consent procedure_San | 1.0 |
| Recruitment arrangements (for publication) | K1_ALKS2680-203_Recruitment procedure_Netherlands | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and consent form | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1 |
| Recruitment arrangements (for publication) | K2_2025-520981-23-00_Recruitement Material_Brochure Global_FRA_San | 1.0 |
| Recruitment arrangements (for publication) | K2_2025-520981-23-00_Recruitement Material_ICF Tool Global_FRA_San | 1.0 |
| Recruitment arrangements (for publication) | K2_2025-520981-23-00_Recruitement Material_PI to Patient Letter_FRA_Red-San | 1.0 |
| Recruitment arrangements (for publication) | K2_2025-520981-23-00_Recruitement Material_Poster_FRA_San | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ICF Tool_English_SAN | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ICF Tool_FR-BE | 1 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ICF Tool_NL-BE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Study Recruitment Brochure_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ICF Tool Global | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ICF Tool Global | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF tool_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation-to-Trial Letter_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation-to-Trial Letter_FR-BE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation-to-Trial Letter_NL-BE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_PI-to-Patient Invitation to Trial Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_FR-BE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_NL-BE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Poster_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Poster_FR-BE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Poster_NL-BE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study PI-to-Patient Invite Letter_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Recruitment Poster_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Vibrance Studies Recruitment Poster Global | 1.0 |
| Recruitment arrangements (for publication) | K2_Vibrance-3 PI-to-Patient Invitation to Trial Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Vibrance-3 Recruitment Brochure Global | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ICF_Dutch_redacted | 5.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ICF_English_redacted | 5.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ICF_French_redacted | 5.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_2025-520981-23-00_ICF_Main_FRA_Red-San | V5.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2025-520981-23-00_ICF_Optional Genetic_FRA_San | V1.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2025-520981-23-00_ICF_Pregnancy_FRA_Red-San | 1.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_ALKS 2680-203_Main ICF_red-san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_ALKS 2680-203_PP ICF_red-san | V1.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Dutch_redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_English_redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_French_redacted | 1.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_san_redacted | V5.0CZE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Privacy Information Sheet_Red-San | 1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Red | 5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Red-San | 5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_Red-San | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | V1.0ESP2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Red-San | 1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sponsor statement on the use of ICF_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ SIS and ICF_Pregnant Partner ICF_san | V1.0CZE2.0 |
| Subject information and informed consent form (for publication) | L2_2025-520981-23-00_Patient_Actigraphy Participant Guide_FRA_San | 1.0 |
| Subject information and informed consent form (for publication) | L2_2025-520981-23-00_Patient_Actigraphy Privacy Policy_FRA_San | No version |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Greenphire reimbursement ICF | V1.0CZE2.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Optional PGx ICF_san | V3.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Patient Data Protection Consent Form_san | CZE2.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Pregnant Partner Data Protection Consent Form_san | CZE2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE DEU_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE FR_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE NL_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZ_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZ_full_2025-520981-23-00_red | 1.3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_2025-520981-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL_2025-520981-23-00 | 1.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-25 | Czechia | Acceptable 2025-08-18
|
2025-08-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-26 | Acceptable | 2025-09-16 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-24 | Czechia | Acceptable 2026-01-22
|
2026-01-22 |