Print Page"Blind individuals who have no light perception do not receive the normal cues from daylight and darkness that regulate our sleep and wake cycles," said Dr.
In a poster presentation entitled, "Seventy Percent of Totally Blind People with Sleep Complaints Are Not Entrained to the 24-Hour Clock," data were reported on the endogenous circadian period (T) for the first 143 subjects enrolled in the ongoing SET study (Safety and Efficacy of Tasimelteon to Treat Non-24), a Phase III clinical trial in totally blind patients. Circadian period was calculated by measuring a urinary melatonin metabolite and secretion rates, collected weekly for 48 hours (at 4-8 hour intervals), for each of the four collection periods. Vanda used this objective evaluation of melatonin secretion by the pineal gland to determine circadian period.
Of the 143 totally blind subjects with sleep complaints in the study, 70% were found to not be entrained to a 24-hour day and, as a result, diagnosed with Non-24. Circadian period (T) in Non-24 patients ranged from 24.08 to 25.34, with a median tau of 24.45 (24 hours and 27 minutes), meaning study subject's internal clocks delay a median of 27 minutes every day. The effect is cumulative, putting subjects to sleep later and later each day until they cycle around the clock and begin again.
"The high prevalence of Non-24 in totally blind individuals with sleep complaints, coupled with frequent underdiagnoses, signals an urgent need to raise awareness in the blind community and with health professionals about the condition," said
Vanda is currently studying the efficacy of tasimelteon in Non-24 in two multi-national Phase III studies, SET and RESET, which are ongoing and expected to be completed by the end of 2012.
The posters presented at SLEEP will be archived for 30 days on the Vanda website at http://www.vandapharma.com/
About Non-24-Hour Sleep Disorder
Non-24-Hour Disorder (Non-24) is a chronic circadian rhythm sleep disorder that affects a majority of totally blind individuals in the U.S., or between 65,000 and 95,000 people. Non-24 occurs almost entirely in individuals who are totally blind and lack the light sensitivity necessary to entrain, or synchronize, the brain's circadian rhythms with the 24-hour day-night cycle. Most people have a circadian clock that naturally runs somewhat longer than 24-hours, and light is the environmental cue that resets it back to 24-hours each day. Non-24 sufferers essentially "free-run" on their own internal clock time, putting them to sleep later and later each day, turning night into day and day into night, until the cycle starts all over again. The sleep condition is highly disruptive, making it difficult to do well in school, hold down a job or maintain relationships. For more information on Non-24, please visit http://24sleepwake.com/.
About Tasimelteon
Tasimelteon is the first compound in development for the treatment of Non-24Disorder. Tasimelteon is a specific and potent agonist of the human MT1 and MT2 receptors. Compounds that selectively bind to melatonin receptors are thought to be able to regulate the body clock, which may be useful to treat circadian rhythm disorders. Tasimelteon is being studied in both Non-24 and Major Depressive Disorder (MDD).
About the SET Study
About the RESET Study
RESET is a randomized withdrawal study designed to demonstrate the maintenance effect of 20 mg tasimelteon in the treatment of Non-24. Twenty totally blind individuals with no light perception and diagnosed as having a body clock period of greater than 24 hours, will be treated with tasimelteon for three months during a run-in phase. Patients who respond to tasimelteon treatment during the run-in phase, as measured by the resetting and alignment of their body clock to the 24-hour day, will then be randomized either to receive placebo or to continue receiving tasimelteon for 2 months. During the post-randomization phase, patients will be re-evaluated. For more information on the RESET study, please visit http://clinicaltrials.gov/.
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