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

Sponsor

Intec Pharma Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01277107

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

13.8

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: Zaleplon AP formulation Drug: Placebo capsule	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Double Blind, Polysomnographic, Two-Way Crossover Study To Compere The Efficacy Of Gastric Retentive Zaleplon (Zaleplon AP) To Placebo In Subjects With Insomnia Characterized By Both Difficulty In Falling Asleep And Staying Asleep

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zaleplon AP formulation Gastric Retentive Dual Release Zaleplon (Zaleplon AP)	Drug: Zaleplon AP formulation Gastric retentive dual release Zaleplon
Placebo Comparator: Placebo Identical placebo capsule	Drug: Placebo capsule Identical placebo capsule

Arm

Intervention/Treatment

Experimental: Zaleplon AP formulation

Gastric Retentive Dual Release Zaleplon (Zaleplon AP)

Drug: Zaleplon AP formulation

Gastric retentive dual release Zaleplon

Placebo Comparator: Placebo

Identical placebo capsule

Drug: Placebo capsule

Identical placebo capsule

Outcome Measures

Primary Outcome Measures

To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST) [Polysomnography tests for 2 consecutive nights at each treatment arm]
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.

Secondary Outcome Measures

To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS) [Polysomnography tests for 2 consecutive nights at each treatment arm]
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO) [Polysomnography tests for 2 consecutive nights at each treatment arm]
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
To evaluate the presence of any residual effects using the digital symbol substitution test (DSST) and a memory test [2 consecutive mornings at each treatment arm]
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Pacific Sleep Medicine	San Diego	California	United States
2	Miami Research Associates	Miami	Florida	United States
3	Broward Research Group	Pembroke Pines	Florida	United States
4	CRG of St. Petersburg	St. Petersburg	Florida	United States
5	Vince and Associates Clinical Research	Overland Park	Kansas	United States
6	Rambam sleep center	Haifa		Israel