Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04652882




Registration number
NCT04652882
Ethics application status
Date submitted
19/11/2020
Date registered
3/12/2020
Date last updated
3/04/2024

Titles & IDs
Public title
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Scientific title
A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
Secondary ID [1] 0 0
VP-VEC-162-3502
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Wake Disorders 0 0
Sleep Disorders, Circadian Rhythm 0 0
Chronobiology Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tasimelteon
Treatment: Drugs - Placebo

Experimental: Tasimelteon -

Placebo Comparator: Placebo -


Treatment: Drugs: Tasimelteon
oral capsule

Treatment: Drugs: Placebo
oral capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Sleep Onset over the treatment period, as measured by sleep diary.
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Timepoint [3] 0 0
28 days

Eligibility
Key inclusion criteria
- Ability and acceptance to provide written informed consent.

- A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).

- Men or women between 18 - 75 years, inclusive.

- Body Mass Index (BMI) of = 18 and = 35 kg/m^2.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Exacerbation of an existing psychiatric condition that requires change in treatment or
intervention in the past 3 months.

- Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days
within the last 30 days.

- Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.

- A positive test for substances of abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Vanda Investigational Site - Glebe
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
München
Country [13] 0 0
Germany
State/province [13] 0 0
Schwerin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vanda Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of
a daily single oral dose of tasimelteon and matching placebo in male and female participants
with DSWPD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04652882
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vanda Pharmaceuticals Inc.
Address 0 0
Country 0 0
Phone 0 0
202-734-3400
Fax 0 0
Email 0 0
VEC162@vandapharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04652882