Clinical trial • Phase III • Neurology
TASIMELTEON for Insomnia disorder
Phase III trial of TASIMELTEON for Insomnia disorder.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Insomnia disorder
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 30-05-2025
- First CTIS Authorization Date
- 23-09-2025
Trial design
Randomised, tasimelteon (oral suspension) administered daily; dosing units mg/kg with maximum daily dose 0.7 mg/kg (max total amount reported 20 mg). comparator: placebo liquid formulation indistinguishable from its tasimelteon counterpart and administered in the same way.-controlled Phase III trial across 10 sites in Poland, Germany.
- Randomised
- Yes
- Comparator
- Tasimelteon (oral suspension) administered daily; dosing units mg/kg with maximum daily dose 0.7 mg/kg (max total amount reported 20 mg). Comparator: Placebo liquid formulation indistinguishable from its tasimelteon counterpart and administered in the same way.
- Target Sample Size
- 370
Eligibility
Recruits 370 paediatric patients.
- Pregnancy Exclusion
- Pregnant or breastfeeding females.
- Vulnerable Population
- Children aged 2 to 17 are included; informed consent must be provided by the legal guardian and assent obtained from the child as required ("Informed consent from the legal guardian (and assent, as required)"). Age-specific information and consent/assent forms are provided.
Inclusion criteria
- {"criterion_text":"- A confirmed clinical diagnosis of insomnia disorder.\n- Reported sleep latency on average 4 nights/week for at least 3 months prior to screening\n- Sleep issues average 4 nights/week and at least 3 nights/week in each of the 4 weeks preceding randomization by sleep diary\n- The sleep disturbance must not be a result of another medication.\n- Male or female between 2 and 17 years of age, inclusive, at Visit 1 (V1).\n- Informed consent from the legal guardian (and assent, as required).\n- Completing the required Daily Sleep Diary during screening;\n- Both guardian and child are willing and able to comply with study requirements and restrictions."}
Exclusion criteria
- {"criterion_text":"- Use of prohibited medications (as detailed in Section 9.2.1 clinical Study Protocol).\n- Previous intolerance to tasimelteon.\n- Unable to dose daily with medication.\n- Pregnant or breastfeeding females.\n- A positive test for drugs of abuse.\n- Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening.\n- Unwilling or unable to follow the medication restrictions including the washout from use of a prohibited medication.\n- Any other sound medical reason as determined by the clinical investigator or the sponsor."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Sleep as measured by daily sleep diary","definition_or_measurement_approach":"Measured by daily sleep diary (as stated: \"as measured by daily diary\")."}
Secondary endpoints
- {"endpoint_text":"- Nighttime subjective sleep parameters as measured by daily sleep diary","definition_or_measurement_approach":"Measured by daily sleep diary (nighttime subjective sleep parameters)."}
- {"endpoint_text":"- Patient Global Impression of Change scale (PGI-C)","definition_or_measurement_approach":"Assessed using the PGI-C scale."}
- {"endpoint_text":"- Clinical Global Impression of Change scale (CGI-C)","definition_or_measurement_approach":"Assessed using the CGI-C scale."}
- {"endpoint_text":"- Caregiver Global Impression of Change scale (CaGI-C)","definition_or_measurement_approach":"Assessed using the CaGI-C scale."}
- {"endpoint_text":"- Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)","definition_or_measurement_approach":"Assessed using the ESS-CHAD scale."}
- {"endpoint_text":"- Sheehan Disability Scale for Pediatrics and Adolescents (SDS-P/A)","definition_or_measurement_approach":"Assessed using the SDS-P/A scale."}
- {"endpoint_text":"- Aberrant Behavior Checklist (ABC)","definition_or_measurement_approach":"Assessed using the ABC instrument."}
- {"endpoint_text":"- Actigraphy parameters","definition_or_measurement_approach":"Measured using actigraphy parameters when tolerated/feasible."}
- {"endpoint_text":"- Tasimelteon pharmacokinetics (PK) in 2-year-old participants","definition_or_measurement_approach":"Characterization of tasimelteon PK in 2-year-old participants (pharmacokinetic assessment)."}
Recruitment
- Planned Sample Size
- 370
- Recruitment Window Months
- 23
- Consent Approach
- Informed consent must be provided by the legal guardian; assent is obtained from participants as required. Age-specific consent/assent documents are provided (Parent/Guardian ICF; ICF/assent templates for ages 16-17, 12-15, 7-11). Documents available in Polish and German based on uploaded consent/assent files.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 90
Poland
- Earliest CTIS Part Ii Submission Date
- 23-08-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 240
- Number Of Sites
- 8
- Number Of Participants
- 65
Sites
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Department Name
- Physician
- Contact Person Name
- Malgorzata Jączak-Goździak
- Contact Person Email
- malgorzata.jaczak-gozdziak@cr-center.pl
- Site Name
- Velocity Nova Sp. z o.o.
- Department Name
- Physician
- Contact Person Name
- Jolanta Mantyka
- Contact Person Email
- jmantyka@velocityclinical.com
- Site Name
- Linden Sp. z o.o. sp.k.
- Department Name
- Physician
- Contact Person Name
- Jakub Antczak
- Contact Person Email
- rejestracja@cmlinden.com
- Site Name
- Ginemedica Research Sp. z o.o.
- Department Name
- Physician
- Contact Person Name
- Maja Krefft
- Contact Person Email
- badaniakliniczne@ginemedica.pl
- Site Name
- Centrum Badań Klinicznych PI-House sp. z o.o.
- Department Name
- Physician
- Contact Person Name
- Anita Sumiła
- Contact Person Email
- a.sumila@pihouse.pl
- Site Name
- Centrum Medyczne "Hipokrates" Elżbieta i Grzegorz Grześk
- Department Name
- Physician
- Contact Person Name
- Elżbieta Grześk
- Contact Person Email
- ela.grzesk@gmail.com
- Site Name
- Wojewódzki Szpital Psychiatryczny im. prof. Tadeusza Bilikiewicza
- Department Name
- Physician
- Contact Person Name
- Jakub Grabowski
- Contact Person Email
- jakub.grabowski@gumed.edu.pl
- Site Name
- Centrum Badań Klinicznych (additional site listed as PI-House?)
- Department Name
- Physician
- Contact Person Name
- Anita Sumiła
- Contact Person Email
- a.sumila@pihouse.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 26-08-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 237
- Number Of Sites
- 2
- Number Of Participants
- 25
Sites
- Site Name
- Velocity Clinical Research Germany GmbH
- Department Name
- Physician
- Contact Person Name
- Thomas Müller
- Contact Person Email
- tmueller@velocityclinical.com
- Site Name
- Advanced Sleep Research GmbH
- Department Name
- Physician
- Contact Person Name
- Katharina Lederer
- Contact Person Email
- info@advanced-sleep-research.de
Sponsor
Primary sponsor
- Full Name
- Vanda Pharmaceuticals Netherlands B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Tasimelteon
- Active Substance
- TASIMELTEON
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (MIA 16262F)
- Frequency
- Daily
- Maximum Dose
- 0.7 mg/kg/day (max total reported 20 mg)
- Investigational Product Name
- Placebo liquid formulation will be indistinguishable from its tasimelteon counterpart and will be administered in the same way.
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Frequency
- Daily
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