Clinical trial • Phase II • Neurology
ALKS 2680 for Idiopathic hypersomnia
Phase II trial of ALKS 2680 for Idiopathic hypersomnia.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Idiopathic hypersomnia
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-04-2025
- First CTIS Authorization Date
- 19-08-2025
Trial design
Randomised, placebo to match alks 2680 (placebo arm listed as 'placebo to match alks 2680'). active comparator arms: 10 mg alks 2680, 14 mg alks 2680, 18 mg alks 2680 (oral tablets). treatment period up to 8 weeks; placebo matches alks 2680 formulation.-controlled Phase II trial in Italy, Netherlands, Belgium and others.
- Randomised
- Yes
- Comparator
- Placebo to match ALKS 2680 (placebo arm listed as 'Placebo to match ALKS 2680'). Active comparator arms: 10 mg ALKS 2680, 14 mg ALKS 2680, 18 mg ALKS 2680 (oral tablets). Treatment period up to 8 weeks; placebo matches ALKS 2680 formulation.
- Target Sample Size
- 81
- Trial Duration For Participant
- 112
Eligibility
Recruits 81 Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information sheets and country-specific informed consent forms are provided (multiple L1/L2 SIS and ICF documents listed for countries/languages). No explicit assent/parental consent procedures for minors are described in the available data (trial population appears to be adult patients)..
- Pregnancy Exclusion
- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
- Vulnerable Population
- Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information sheets and country-specific informed consent forms are provided (multiple L1/L2 SIS and ICF documents listed for countries/languages). No explicit assent/parental consent procedures for minors are described in the available data (trial population appears to be adult patients).
Inclusion criteria
- {"criterion_text":"- 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.\n- 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
- {"criterion_text":"- Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1\n- Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.\n- 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.\n- Is currently pregnant, breastfeeding, or is planning to become pregnant during the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level.","definition_or_measurement_approach":"Change in Epworth Sleepiness Scale (ESS) score from baseline to Week 8, analysed by dose level (ESS is a patient-reported sleepiness scale)."}
Secondary endpoints
- {"endpoint_text":"- Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level.","definition_or_measurement_approach":"Change in Idiopathic Hypersomnia Severity Scale (IHSS) score from baseline to Week 8, analysed by dose level."}
- {"endpoint_text":"- • TEAEs • Clinical laboratory assessments • Vital signs • Safety ECG • C-SSRS","definition_or_measurement_approach":"Safety and tolerability assessments including treatment-emergent adverse events (TEAEs) reporting, clinical laboratory testing, vital signs measurements, safety ECGs, and assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS)."}
Recruitment
- Planned Sample Size
- 81
- Recruitment Window Months
- 18
- Consent Approach
- Informed consent obtained via subject information sheets and country-specific informed consent forms (multiple L1/L2 SIS and ICF documents available). Consent materials exist in multiple languages/country versions (examples: English, French, Dutch, Czech, Italian, Spanish indicated by country-versioned ICF documents). No explicit assent or paediatric consent materials described; consent appears to be obtained from adult participants via the listed ICFs.
Methods
- Country-specific recruitment materials and channels: brochures, posters, PI-to-patient invitation letters, recruitment brochures and global recruitment posters (documents K2 and K1 listed for multiple countries). Recruitment duties assigned to third parties (e.g. Praxis Communications LLC listed with duty 'Recruitment'). Recruitment appears organised with country-specific K1/K2 materials (Netherlands, Belgium, France, Spain, Czechia, etc.).
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 15
Italy
- Earliest CTIS Part Ii Submission Date
- 11-08-2025
- Latest Decision Or Authorization Date
- 27-01-2026
- Processing Time Days
- 169
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Istituto San Raffaele
- Department Name
- UO Neurologia-Centro di Medicina del Sonno
- Contact Person Name
- Luigi Ferini-Strambi
- Contact Person Email
- ferinistrambi.luigi@hsr.it
- Site Name
- Instituto Di Ricovero E Cura A Carattere Scientifico
- Department Name
- Neurologia
- Contact Person Name
- Giuseppe Plazzi
- Contact Person Email
- giuseppe.plazzi@unibo.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- CRC
- Contact Person Name
- Giuseppe Plazzi
- Contact Person Email
- giuseppe.plazzi@crc.vr.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-08-2025
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 154
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Epilepsie Instellingen Nederland Stichting
- Department Name
- Neurology
- Contact Person Name
- Gert Jan Lammers
- Contact Person Email
- gjlammers@sein.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 181
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Pneumocare
- Department Name
- Medical Research Center
- Contact Person Name
- Jean-Benoît Martinot
- Contact Person Email
- martinot.j@respisom.be
- Site Name
- Anima
- Department Name
- Research Center
- Contact Person Name
- Erik Buntinx
- Contact Person Email
- erik.buntinx@anima-alken.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 172
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Neurologická klinika
- Contact Person Name
- Karel Šonka
- Contact Person Email
- karel.sonka@vfn.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 179
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Fundacion Vithas
- Department Name
- Neurology
- Contact Person Name
- Rafael Del Rio Villegas
- Contact Person Email
- rafaeldelrv@gmail.com
- Site Name
- Instituto De Investigaciones Del Sueno S.L.
- Department Name
- Neurology
- Contact Person Name
- Diego Garcia Borreguero
- Contact Person Email
- dgb.investigation@iis.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Neurology
- Contact Person Name
- Alejandro Iranzo de Riquer
- Contact Person Email
- airanzo@clinic.cat
France
- Earliest CTIS Part Ii Submission Date
- 03-06-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 234
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Sleep Medicine
- Contact Person Name
- Pierre PHILIP
- Contact Person Email
- pierre.philip@u-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Pneumology/ Physiology, Sleep and Exercise
- Contact Person Name
- Jean Louis PEPIN
- Contact Person Email
- jpepin@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Neurologie
- Contact Person Name
- Yves DAUVILLIERS
- Contact Person Email
- y-dauvilliers@chu-montpellier.fr
Sponsor
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 (listed in sponsorDuties for IQVIA Limited)
- Name
- Eresearchtechnology Inc.
- Responsibilities
- ECG
- Name
- Suvoda LLC
- Responsibilities
- code 3
- Name
- Medidata Solutions Inc.
- Responsibilities
- code 7
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"American National Red Cross","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clinilabs Inc.","duties_or_roles":"EEG/PSG","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Actigraph LLC","duties_or_roles":"Actigraphy","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":"Praxis Communications LLC","duties_or_roles":"Recruitment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Australia","full_name":"Cogstate Limited","duties_or_roles":"Cognitive tests","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes 1,10,12,14,2,5,6","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ALKS 2680
- Active Substance
- ALKS 2680
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Not authorised in the population involved in the planned clinical trial
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg | 14 mg | 18 mg
- Maximum Dose
- 18 mg
- Dose Escalation Increase
- 10 mg, 14 mg, 18 mg
- Investigational Product Name
- Placebo to match ALKS 2680
- Modality
- Other
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