A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL PROOF OF CONCEPT STUDY TO EVALUATE THE EFFECTS OF MULTIPLE ORAL DOSES OF TASIMELTEON AND MATCHING PLACEBO IN TRAVELERS WITH JET LAG DISORDER

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2016
INTERVENTION: Trade Name: HETLIOZ® Product Name: Tasimelteon (HETLIOZ®) Product Code: VEC‐162 Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: Jet Lag Disorder (JLD) ; MedDRA version: 20.0 Level: PT Classification code 10040984 Term: Sleep disorder System Organ Class: 10037175 ‐ Psychiatric disorders Therapeutic area: Not possible to specify PRIMARY OUTCOME: Main Objective: To assess the effects of tasimelteon 20 mg on nighttime sleep parameters as measured by Polysomnography (PSG) after transmeridian travel Primary end point(s): The primary endpoint is the effectoftasimelteon 20mg on nighttime sleep parameters as measured by Polysomnography (PSG)aftertransmeridian travel.. The primary efficacy analysis will be based on the ITT population. Secondary Objective: Key Secondary Objectives:; 1. To assess the effects of tasimeleton 20mg on nighttime objective parameters.; 2. To assess the effects of tasimeleton 20mg on nighttime subjective parameters.; 3. To assess the effect of tasimeleton 20mg on a daytime objective parameter.; 4. To assess the effects of tasimeleton 20mg on daytime subjective parameters.; 5. To assess the effects of tasimeleton 20mg as measured by a combined scale of nighttime and daytime symptoms. SECONDARY OUTCOME: Secondary end point(s): The secondary efficacy outcomes include: ; ‐ To assess the effects of tasimeleton 20mgonnighttime objective parameters ; ‐ To assess the effects of tasimeleton 20mg on nighttime subjective parameters ; ‐ To assess the effect of tasimeleton 20mg on a daytime objective parameter ; ‐ To assess the effects of tasimeleton 20mg on daytime subjective parameters ; ‐ To assess the effects of tasimeleton 20mgas measured by a combined scale of nighttime and daytime symptoms INCLUSION CRITERIA: 1. Ability and acceptance to provide written informed consent 2. Men or women between 18 – 75 years, inclusive 3. A Jet Lag Symptom Scale (JLSS) total score of = 4 AND at least one night of Sleep Efficiency = 85% during the first two thirds of any night. The JLSS will be determined as follows: Subjects will receive a score of 2 for Sleep Efficiency that is = 80% or receive a score of 1 if it is = 85% during the first two thirds of the 8‐hour sleep period on each night. Subjects will also receive a score of 2 for an average KSS score of = 6 for each day. All the scores across 3 nights and 3 days will be added as the total score ranging from 0 to 12. 4. Body Mass Index (BMI) of = 18 and = 30 kg/m2 (BMI = weight (kg)/ [height (m)]2) 5. Valid passport for international travel and fluent in English; 6. Males, non‐fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without mense
Epistemonikos ID: be116b53454f76f8244af00b0b25a3d687a35745
First added on: Aug 24, 2024