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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zaleplon AP formulation
Placebo capsule
Sponsored by
Intec Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring PSG, LPS, TST, WASO, Subjects With Insomnia characterized by both Difficulty in Falling Asleep and Staying Asleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pacific Sleep Medicine
  • Miami Research Associates
  • Broward Research Group
  • CRG of St. Petersburg
  • Vince and Associates Clinical Research
  • Rambam sleep center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zaleplon AP formulation

Placebo

Arm Description

Gastric Retentive Dual Release Zaleplon (Zaleplon AP)

Identical placebo capsule

Outcomes

Primary Outcome Measures

To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST)
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)
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)
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
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.

Full Information

First Posted
January 12, 2011
Last Updated
December 18, 2014
Sponsor
Intec Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01277107
Brief Title
A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intec Pharma Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
PSG, LPS, TST, WASO, Subjects With Insomnia characterized by both Difficulty in Falling Asleep and Staying Asleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zaleplon AP formulation
Arm Type
Experimental
Arm Description
Gastric Retentive Dual Release Zaleplon (Zaleplon AP)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo capsule
Intervention Type
Drug
Intervention Name(s)
Zaleplon AP formulation
Intervention Description
Gastric retentive dual release Zaleplon
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Intervention Description
Identical placebo capsule
Primary Outcome Measure Information:
Title
To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST)
Description
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time Frame
Polysomnography tests for 2 consecutive nights at each treatment arm
Secondary Outcome Measure Information:
Title
To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS)
Description
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time Frame
Polysomnography tests for 2 consecutive nights at each treatment arm
Title
To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO)
Description
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time Frame
Polysomnography tests for 2 consecutive nights at each treatment arm
Title
To evaluate the presence of any residual effects using the digital symbol substitution test (DSST) and a memory test
Description
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Time Frame
2 consecutive mornings at each treatment arm

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pacific Sleep Medicine
City
San Diego
State/Province
California
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
Country
United States
Facility Name
Broward Research Group
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
CRG of St. Petersburg
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Rambam sleep center
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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