Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vanda Pharmaceuticals Netherlands B.V., Vanda Pharmaceuticals Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

25 Feb 2026 → ongoing

Decision date (initial)

2025-09-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Vanda Pharmaceuticals Inc

External identifiers

EU CT number

2024-516411-24-00

ClinicalTrials.gov

NCT06953869

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the efficacy of tasimelteon administered daily compared to placebo sleep outcomes in participants, as measured by daily diary.

Secondary objectives 6

1. To evaluate the efficacy of tasimelteon administered daily compared to placebo in the following measures: a. Nighttime subjective sleep parameters such as sleep quality, wake time, and total sleep time, as measured by daily sleep diary; b. Patient Global Impression of Change scale (PGI-C); c. Clinical Global Impression of Change scale (CGI-C).
2. To evaluate the efficacy of tasimelteon administered daily vs placebo, as measured by improvement in daytime functioning from the following measures: a. Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD); b. Sheehan Disability Scale for Pediatrics and Adolescents (SDS-P/A).
3. To evaluate the impact of sleep improvement on behavior, as measured by the Aberrant Behavior Checklist (ABC).
4. To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvements in actigraphy parameters.
5. To characterize the pharmacokinetics (PK) of an age-appropriate oral formulation of tasimelteon in 2-year-old participants.
6. To evaluate the safety and tolerability of repeated doses of tasimelteon in pediatric participants with insomnia disorder.

Conditions and MedDRA coding

Insomnia Disorder

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. A confirmed clinical diagnosis of insomnia disorder.
2. Reported sleep latency on average 4 nights/week for at least 3 months prior to screening
3. Sleep issues average 4 nights/week and at least 3 nights/week in each of the 4 weeks preceding randomization by sleep diary
4. The sleep disturbance must not be a result of another medication.
5. Male or female between 2 and 17 years of age, inclusive, at Visit 1 (V1).
6. Informed consent from the legal guardian (and assent, as required).
7. Completing the required Daily Sleep Diary during screening;
8. Both guardian and child are willing and able to comply with study requirements and restrictions.

Exclusion criteria 8

1. Use of prohibited medications (as detailed in Section 9.2.1 clinical Study Protocol).
2. Previous intolerance to tasimelteon.
3. Unable to dose daily with medication.
4. Pregnant or breastfeeding females.
5. A positive test for drugs of abuse.
6. Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening.
7. Unwilling or unable to follow the medication restrictions including the washout from use of a prohibited medication.
8. Any other sound medical reason as determined by the clinical investigator or the sponsor.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Sleep as measured by daily sleep diary

Secondary endpoints 9

1. Nighttime subjective sleep parameters as measured by daily sleep diary
2. Patient Global Impression of Change scale (PGI-C)
3. Clinical Global Impression of Change scale (CGI-C)
4. Caregiver Global Impression of Change scale (CaGI-C)
5. Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
6. Sheehan Disability Scale for Pediatrics and Adolescents (SDS-P/A)
7. Aberrant Behavior Checklist (ABC)
8. Actigraphy parameters
9. Tasimelteon pharmacokinetics (PK) in 2-year-old participants

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vanda Pharmaceuticals Netherlands B.V.

Sponsor organisation

Vanda Pharmaceuticals Netherlands B.V.

Address

Basisweg 10

City

Amsterdam

Postcode

1043 AP

Country

Netherlands

Scientific contact point

Organisation

Vanda Pharmaceuticals Netherlands B.V.

Contact name

Christos Polymeropoulos

Public contact point

Organisation

Vanda Pharmaceuticals Netherlands B.V.

Contact name

Vanda Insomnia

Vanda Pharmaceuticals Inc.

Sponsor organisation

Vanda Pharmaceuticals Inc.

Address

2200 Pennsylvania Avenue Northwest Suite 300

City

Washington

Postcode

20037-1709

Country

United States

Sponsor responsibilities

Article 77 compliance

Vanda Pharmaceuticals Netherlands B.V.

Contact point sponsor

Vanda Pharmaceuticals Netherlands B.V.

Article 77 implementation

Vanda Pharmaceuticals Netherlands B.V.

Locations

2 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications