--- title: Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) nct_id: NCT04652882 overall_status: RECRUITING phase: PHASE3 sponsor: Vanda Pharmaceuticals study_type: INTERVENTIONAL primary_condition: Sleep Wake Disorders countries: United States, Austria, Germany canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04652882.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04652882" ct_last_update_post_date: 2025-12-02 last_seen_at: "2026-05-12T06:56:29.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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) **NCT ID:** [NCT04652882](https://clinicaltrials.gov/study/NCT04652882) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 70 - **Lead Sponsor:** Vanda Pharmaceuticals - **Conditions:** Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders - **Start Date:** 2020-12-09 - **Completion Date:** 2026-06 - **CT.gov Last Update:** 2025-12-02 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. 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. * Current tobacco user. ``` ## Arms - **Tasimelteon** (EXPERIMENTAL) - **Placebo** (PLACEBO_COMPARATOR) ## Interventions - **Tasimelteon** (DRUG) — oral capsule - **Placebo** (DRUG) — oral capsule ## Primary Outcomes - **Change in Sleep Onset over the treatment period, as measured by sleep diary.** _(time frame: 28 days)_ ## Secondary Outcomes - **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)_ ## Locations (17) - Vanda Investigational Site, Los Angeles, California, United States — _RECRUITING_ - Vanda Investigational Site, Redwood City, California, United States — _RECRUITING_ - Vanda Investigational Site, Aurora, Colorado, United States — _RECRUITING_ - Vanda Investigational Site, Boston, Massachusetts, United States — _RECRUITING_ - Vanda Investigational Site, St Louis, Missouri, United States — _RECRUITING_ - Vanda Investigational Site, New Hyde Park, New York, United States — _RECRUITING_ - Vanda Investigational Site, Cincinnati, Ohio, United States — _RECRUITING_ - Vanda Investigational Site, Cleveland, Ohio, United States — _RECRUITING_ - Vanda Investigational Site, Columbia, South Carolina, United States — _RECRUITING_ - Vanda Investigational Site, San Antonio, Texas, United States — _RECRUITING_ - Vanda Investigational Site, Sherman, Texas, United States — _RECRUITING_ - Vanda Investigational Site, Innsbruck, Austria — _ACTIVE_NOT_RECRUITING_ - Vanda Investigational Site, Vienna, Austria — _RECRUITING_ - Vanda Investigational Site, Berlin, Germany — _RECRUITING_ - Vanda Investigational Site, Hamburg, Germany — _RECRUITING_ - Vanda Investigational Site, Marburg, Germany — _RECRUITING_ - Vanda Investigational Site, Schwerin, Germany — _RECRUITING_ ## Recent Field Changes (last 30 days) - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.vanda investigational site|los angeles|california|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|redwood city|california|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|new hyde park|new york|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|columbia|south carolina|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|sherman|texas|united states` — added _(2026-05-12)_ - `locations.vanda investigational site|innsbruck||austria` — added _(2026-05-12)_ - `locations.vanda investigational site|vienna||austria` — added _(2026-05-12)_ - `locations.vanda investigational site|berlin||germany` — added _(2026-05-12)_ - `locations.vanda investigational site|hamburg||germany` — added _(2026-05-12)_ - `locations.vanda investigational site|marburg||germany` — added _(2026-05-12)_ - `locations.vanda investigational site|schwerin||germany` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04652882.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04652882* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*