Clinical trial • Phase II • Neurology
ORX750 for Narcolepsy | Idiopathic hypersomnia
Phase II trial of ORX750 for Narcolepsy | Idiopathic hypersomnia.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Narcolepsy | Idiopathic hypersomnia
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-02-2025
- First CTIS Authorization Date
- 12-05-2025
Trial design
Randomised, orx750 matching placebo (placebo comparator); dose and schedule not specified in the available data-controlled Phase II trial across 9 sites in Italy, Spain, France.
- Randomised
- Yes
- Comparator
- Orx750 matching placebo (placebo comparator); dose and schedule not specified in the available data
- Target Sample Size
- 114
- Trial Duration For Participant
- 28
Eligibility
Recruits 114 No vulnerable population selected. Participants aged 18-65 only; no vulnerable population or assent/parental consent handling specified in the available record..
- Vulnerable Population
- No vulnerable population selected. Participants aged 18-65 only; no vulnerable population or assent/parental consent handling specified in the available record.
Inclusion criteria
- {"criterion_text":"- 18-65 years of age\n- BMI ≥17 and ≤37 kg/m2\n- Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria\n- Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia\n- Is willing and able to adhere to additional protocol requirements"}
Exclusion criteria
- {"criterion_text":"- A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).\n- Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.","definition_or_measurement_approach":"Incidence, severity and causal relationship of treatment-emergent adverse events (TEAEs) including serious TEAEs; changes from baseline in laboratory tests (biochemistry, haematology, urinalysis), vital signs, weight, 12-lead ECGs; and Columbia-Suicide Severity Rating Scale (C-SSRS) scores comparing ORX750 versus placebo."}
Secondary endpoints
- {"endpoint_text":"- PK-Day 1: Cmax, tmax, and AUC0-last; Days 14 and 28: Cmax,ss, tmax, and AUCτ, and other PK parameters as appropriate.","definition_or_measurement_approach":"Pharmacokinetic assessments: Day 1 parameters Cmax, tmax, AUC0-last; Days 14 and 28: Cmax,ss, tmax, AUCτ and additional PK parameters as appropriate."}
- {"endpoint_text":"- PD-mean sleep latency (average of the first 4 trials) in the MWT for ORX750 versus placebo and subjective daytime sleepiness using the ESS, including change from baseline to specified postdose time points.","definition_or_measurement_approach":"Pharmacodynamic assessments: mean sleep latency in the Maintenance of Wakefulness Test (MWT) (average of first 4 trials) and subjective daytime sleepiness measured by the Epworth Sleepiness Scale (ESS), including change from baseline to specified post-dose time points."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 114
- Recruitment Window Months
- 8
- Consent Approach
- Informed consent to be obtained from participants (adult participants aged 18-65). Subject information and informed consent form documents available in multiple languages (English, Spanish, French, Italian) as indicated by L1_SIS and ICF_Main documents in EN/ES/FR/IT; no assent or parental consent procedures specified.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 34
Italy
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 249
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- UOC Clinica Neurologica
- Principal Investigator Name
- Giuseppe Plazzi
- Principal Investigator Email
- giuseppe.plazzi@unibo.it
- Contact Person Name
- Giuseppe Plazzi
- Contact Person Email
- giuseppe.plazzi@unibo.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- UOC Neurologia/Neurofisiopatologia
- Principal Investigator Name
- Fabio Placidi
- Principal Investigator Email
- fbplacidi@gmail.com
- Contact Person Name
- Fabio Placidi
- Contact Person Email
- fbplacidi@gmail.com
- Site Name
- Istituto Neurologico Mediterraneo Neuromed S.p.A.
- Department Name
- Neurology
- Principal Investigator Name
- Andrea Romigi
- Principal Investigator Email
- andrea.romigi@neuromed.it
- Contact Person Name
- Andrea Romigi
- Contact Person Email
- andrea.romigi@neuromed.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Neurology
- Principal Investigator Name
- Giuseppe Plazzi
- Principal Investigator Email
- giuseppe.plazzi@unibo.it
- Contact Person Name
- Giuseppe Plazzi
- Contact Person Email
- giuseppe.plazzi@unibo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 07-05-2025
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 225
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Araba
- Department Name
- Unidad del Sueño
- Principal Investigator Name
- Ainhoa Álvarez Ruiz de Larrinaga
- Principal Investigator Email
- ainhoaarl@gmail.com
- Contact Person Name
- Ainhoa Álvarez Ruiz de Larrinaga
- Contact Person Email
- ainhoaarl@gmail.com
- Site Name
- Instituto De Investigaciones Del Sueno S.L.
- Department Name
- Unidad del Sueño
- Principal Investigator Name
- Diego Garcia Borreguero
- Principal Investigator Email
- dgb@iis.es
- Contact Person Name
- Diego Garcia Borreguero
- Contact Person Email
- dgb@iis.es
- Site Name
- Hospital Nuestra Senora De America
- Department Name
- Neurophysiology and Sleep Disorders
- Principal Investigator Name
- Rafael Del Rio Villegas
- Principal Investigator Email
- rafaeldelrv@gmail.com
- Contact Person Name
- Rafael Del Rio Villegas
- Contact Person Email
- rafaeldelrv@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 22-12-2024
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 381
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Unité des Troubles du Sommeil, Département de Neurologie
- Principal Investigator Name
- Yves Dauvilliers
- Principal Investigator Email
- y-dauvilliers@chu-montpellier.fr
- Contact Person Name
- Yves Dauvilliers
- Contact Person Email
- y-dauvilliers@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Plateforme de recherche Neuropsychopharmocologique
- Principal Investigator Name
- Pierre Philip
- Principal Investigator Email
- pierre.philip@u-bordeaux.fr
- Contact Person Name
- Pierre Philip
- Contact Person Email
- pierre.philip@u-bordeaux.fr
Sponsor
Primary sponsor
- Full Name
- Centessa Pharmaceuticals UK Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Syneos Health UK Limited
- Responsibilities
- Sponsor duties codes: 1,10,11,12,13,2,3,5,6,7 (codes as provided in record)
- Name
- Fortrea Inc.
- Responsibilities
- code 8
Third parties
- {"country":"United Kingdom","full_name":"Cambridge Cognition Limited","duties_or_roles":"Cognitive Assessment Vendor for collection of PerfRO data","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Millmount Healthcare Limited","duties_or_roles":"Package and label. QP Release","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"CliniChain B.V.","duties_or_roles":"Supply of Equipment / devices","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,2,3,5,6,7 (codes as provided in record)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Neonstone Limited","duties_or_roles":"Vendor developing and hosting site training, education, and recruitment portal","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"Package and label. QP Release","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"PK analysis; code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinilabs Inc.","duties_or_roles":"Central Polysomnography and MWT scoring","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA vendor for collection of ePRO, eDiary, ClinRO, and PerfRO data","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ORX750
- Active Substance
- ORX750
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- Orx750 matching placebo
- Modality
- Other
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