Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)

• ClinicalTrials.gov Identifier: NCT04652882
• Recruitment Status: Recruiting
• First Posted: December 3, 2020
• Last Update Posted: January 19, 2021
• Sponsor: Vanda Pharmaceuticals
• Information provided by (Responsible Party): Vanda Pharmaceuticals

Tracking Information

• First Submitted Date: November 19, 2020
• First Posted Date: December 3, 2020
• Last Update Posted Date: January 19, 2021
• Actual Study Start Date: December 9, 2020
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 2, 2020): Change in Sleep Onset over the treatment period, as measured by sleep diary. [ Time Frame: 28 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 2, 2020)

• Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy. [ Time Frame: 28 days ]
• Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary. [ Time Frame: 28 days ]
• Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [ Time Frame: 28 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
• Official Title: A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Sleep Wake Disorders
• Sleep Disorders, Circadian Rhythm
• Chronobiology Disorders

Intervention

• Drug: Tasimelteon
  oral capsule
• Drug: Placebo
  oral capsule

Study Arms

• Experimental: Tasimelteon
  Intervention: Drug: Tasimelteon
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 2, 2020): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 - 65 years, inclusive.
• Body Mass Index (BMI) of ≥ 18 and ≤ 30 kg/m^2.

Exclusion Criteria:

• History of psychiatric disorders within 12 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Vanda Pharmaceuticals Inc.; 202-734-3400; VEC162@vandapharma.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04652882
• Other Study ID Numbers: VP-VEC-162-3502
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Vanda Pharmaceuticals
• Study Sponsor: Vanda Pharmaceuticals
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Vanda Pharmaceuticals
• Verification Date: January 2021