A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia

Intec Pharma

Status and phase

Completed

Phase 2

Conditions

Insomnia

Treatments

Drug: Zaleplon AP formulation

Drug: Placebo capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01277107

IN 09 006

Details and patient eligibility

About

This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo.

Enrollment

83 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects between the ages of 18 and 65 years of age
Subjects that meet DSM IV diagnostic criteria for Primary Insomnia
Subjects that report a time in bed ≥6.5 and ≤9 hours
Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST ≤6.5 hours
Subjects that report on a one week sleep diary (on at least 3 of 7 nights)Wake time after sleep >1.0 hour
Subjects that report on a one week sleep diary (on at least 3 of 7 nights) ≥30 minutes time to sleep onset
On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
On two nights of PSG screening a TST of ≤6.5 hours on each of the two nights
Body mass index of 18 - 34 inclusive
Subjects that report a median habitual bedtime between 9:00pm (21:00 hours) and 12:00am (00:00) on a one week sleep diary (based on 3 or more nights).

Exclusion criteria

Participation in another drug clinical trial within 1 month prior to first screening diary day (calculated from the previous study's last dosing date).
On screening PSG night 1 an AHI >10 (apnea hypopnea index)
On screening PSG night 1 a PLMAI ≥10 (periodic limb movements with arousal)
Subject has a circadian rhythm disorder including shift work or the need to travel ≥3 time zones during the course of the study
Subject has any other sleep disorder (e.g. Restless Legs Syndrome )
Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
Subject with a history (past year) of alcohol or substance abuse
Subject that needs to smoke during the sleep period time
Subject that reports habitual napping (more than 3 times per week)
Subject has currently or a significant history of seizures, sleep apnea or restless leg syndrome or other sleep disorders which, in the opinion of the investigator responsible, contraindicates his/her participation
Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy which, in the opinion of the investigator responsible, contraindicates his/her participation
Subject with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, intestinal obstruction, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology which, in the opinion of the investigator responsible, contraindicates his/her participation
Subjects suffering from any Axis 1 Psychiatric Disorder that in the opinion of the investigator responsible may interfere with full participation
Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the investigator responsible, contraindicates his/her participation.
The subject has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator
Subject is taking CNS-active drugs (including herbal products with CNS effects), known to affect the sleep/wake cycle including but not limited to anxiolytic, hypnotics, antidepressants, sedating H1 antihistamines, systemic steroids, anticonvulsants, narcotic analgesics, respiratory stimulants respiratory decongestants, OTC and prescription diet aids, OTC and prescription stimulants, St. John's Wort, and melatonin.
Females who are pregnant or nursing.