Jet Lag Disorder (JLD) MedDRA version: 20.0 Level: PT Classification code 10040984 Term: Sleep disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: HETLIOZ®
Product Name: Tasimelteon (HETLIOZ®)
Product Code: VEC-162
Pharmaceutical Form: Capsule
Pharmaceutical form of the
Sponsors
Vanda Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control (i.e., condoms, diaphragm, spermicidal agents, cervical cap) for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline and D1 visits; a. Note: Women using hormonal methods of birth control must use an additional method of birth control during the study and for one month after the last dose. Valid passport for international travel and fluent in English 7. In good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology 8. Willing to comply with study procedures and restrictions with fixed sleep time and wake time during the study and to attend regularly scheduled clinic visits as specified in this protocol 9. Has negative urine test result for selected substances of abuse at V1- through the end of the randomization phase 10. Has not used pharmacological sleep assistance more than 4 times/month during the 3 months prior to screening 11. Must have discontinued use of all pharmacological sleep aids beginning 1 week prior to Visit 2 and for the duration of the trial 12. Must have a target daily bedtime that on average occurs between 21:00 and 00:00 13. eDiary and actigraphy must demonstrate, on average, that the total sleep time each night is between 7 to 9 hours during screening during the week preceding V2; 14. eDiary and actigraphy must demonstrate that on most nights (5 of the 7 days) the subject’s habitual bedtime does not differ by more than 2 hours during screening the week preceding V2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 39 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. History of primary insomnia or any circadian rhythm sleep disorder, other than jet lag, as defined by ICSD-3 2. History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures 3. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable 4. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists 5. Indication of impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) or bilirubin > than 2 times the Upper Limit of Normal) 6. Clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings at screening or baseline as determined by the clinical investigator 7. Major surgery, trauma (including broken pelvis/legs), illness (e.g. sepsis, stroke) or immobile for 3 or more days within the past month 8. Current smoker or quit smoking within the last 30 days 9. Active cancer or cancer treatment within the past 6 months 10. Central venous catheter in place or within the past month 11. History of pulmonary embolism /deep vein thrombosis (DVT) or short term blood thinner treatment as an outpatient (e.g. Coumadin, Lovenox, heparin) 12. History or family history of thrombosis or hypercoagulable state (e.g. Factor V Leiden, Factor VIII deficiency, Protein C & S deficiency) 13. Pregnancy or recent pregnancy (within 6 weeks) 14. History of restless leg syndrome, sleep apnea, or periodic limb movement disorder and or have current diagnosis as confirmed by the diagnostic PSG in VP-VEC-162-0101 15. Habitual bedtime varies by more than two hours, on average 16. History or evidence of excessive daytime sleepiness as determined by a score of more than 10 on the Epworth Sleepiness Scale; 17. History of drug or alcohol abuse as defined in DSM-V, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening and/or regular consumption of alcoholic drinks (> 2 drinks/day or > 14 drinks/week) 18. A positive test for drugs of abuse at the screening visit; 19. Traveled more than three time zones 2 weeks prior to the screening visit until the travel period. 20. Traveled outside the origination time zone within 1 week before the end of the screening period. 21. An average bedtime that varies more than 2 hours per week than the target bedtime during the weeks between the screening visit and the baseline visit based on patient reported sleep diaries and actigraphy. 22. Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit. 23. Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial (does not pertain to VP-VEC-162-0101)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of tasimelteon 20 mg on nighttime sleep parameters as measured by Polysomnography (PSG) after transmeridian travel; 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. ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom, United States
Contacts
Public ContactAndrew Masih
Medpace UK
Outcome results
None listed