VP-VEC-162-3106 Tasimelteon in travellers with jet lag disorder
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of multiple oral doses of tasimelteon and matching placebo in travellers with Jet Lag Disorder
IRAS ID
191308
Contact name
Adrian J Williams
Contact email
Sponsor organisation
Vanda Pharmaceuticals Inc.
Eudract number
2015-003198-14
Clinicaltrials.gov Identifier
054776, IND Number
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
Jet Lag is a disorder in which there is a temporary mismatch between the timing of the sleep-wake cycle caused by adjusting to a new time zone. Individuals who have jet lag typically complain of disturbed sleep and feeling drowsy and lethargic, with symptoms worsening with the more time zones that have been crossed and travelling West to East. It is reported that 80% of individuals who travel across time zones suffer from jet lag or sleep disruption.
There is no approved treatment for jet lag. Current therapies include light therapy to slowly change the sleep-wake cycle in advance of a trip, and taking melatonin nutritional supplements or sleeping pills. There is an unmet need for the use of a medication to directly treat jet lag disorder.
Vanda Pharmaceuticals have developed a drug, tasimelteon, that has been designed to bind to melatonin receptors which are thought to be involved in the control of the body clock. This drug is already marketed for the treatment of Non-24 (disorder where a person’s sleep-wake cycle is longer than 24 hours) in adults.
This study is being done to assess the effects of tasimelteon on jet lag symptoms after long-haul air travel.
This is a multicentre study which will take place across Europe and United States. Participants will be recruited in the United States and will be flown to sites in Europe on a non-stop overnight flight, crossing 5-8 time zones. It is anticipated that approximately 400 patients will be enrolled.
This is a double-blind, randomised, placebo-controlled study meaning that patients will be randomly assigned to receive either 20 mg tasimelteon or placebo (looks like the study drug but with no active ingredient) in capsule form before bedtime for 3 nights after their flight. Neither the patient nor the study doctor will know which medication is being given.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1941
Date of REC Opinion
15 Dec 2015
REC opinion
Further Information Favourable Opinion