A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Dual Release Zaleplon AP (Zaleplon Accordion Pill) to Placebo in Subjects With Insomnia

This study has been completed.
Sponsor:
Information provided by:
Intec Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01277107
First received: January 12, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

This is a multi center, double blind placebo controlled, three-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 2 formulations of the Zaleplon AP to placebo.


Condition Intervention Phase
Insomnia
Drug: Zaleplon AP formulation A
Drug: Zaleplon AP formulation B
Drug: Placebo capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Polysomnographic, Three-Way Crossover Study to Compare the Efficacy of Two Doses of Gastric Retentive Dual Release Zaleplon (Zaleplon AP) to Placebo in Subjects With Insomnia Characterized by Both Difficulty in Falling Asleep and Staying Asleep

Resource links provided by NLM:


Further study details as provided by Intec Pharma Ltd.:

Primary Outcome Measures:
  • Polysomnography (PSG)determined Wake time After Sleep Onset (WASO) [ Designated as safety issue: No ]
    The change from baseline on the mean of drug nights 1 and 2 relative to placebo.


Secondary Outcome Measures:
  • Objective and Subjective sleep parameters [ Designated as safety issue: Yes ]
    • Total Sleep Time (TST) from PSG
    • Latency to Persistent Sleep (LPS) from PSG
    • subject reported sleep parameters as determined by a post sleep questionnaire (PSQ) specifically sTST, subjective latency to sleep onset (sLSO), and sWASO, sleep quality and number of awakenings
    • presence of any residual effects using the Digit Symbol Substitution Test (DSST) and a memory test
    • monitor the subjects for adverse events


Estimated Enrollment: 60
Study Start Date: January 2011
Study Completion Date: September 2011
Arms Assigned Interventions
Experimental: Zaleplon AP formulation A
Gastric Retentive Dual Release Zaleplon (Zaleplon AP) formulation A
Drug: Zaleplon AP formulation A
Gastric retentive dual release Zaleplon
Experimental: Zaleplon AP formulation B
Gastric Retentive Dual Release Zaleplon (Zaleplon AP) formulation B
Drug: Zaleplon AP formulation B
Gastric retentive dual release Zaleplon
Placebo Comparator: Placebo
Identical placebo capsule
Drug: Placebo capsule
Identical placebo capsule

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277107

Locations
United States, California
Pacific Sleep Medicine
San Diego, California, United States
United States, Florida
Miami Research Associates
Miami, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
CRG of St. Petersburg
St. Petersburg, Florida, United States
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Israel
Rambam sleep center
Haifa, Israel
Sponsors and Collaborators
Intec Pharma Ltd.
  More Information

No publications provided

Responsible Party: Hadas Friedman, Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01277107     History of Changes
Other Study ID Numbers: IN 09 006
Study First Received: January 12, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Intec Pharma Ltd.:
PSG
LPS
TST
WASO
Subjects With Insomnia characterized by both Difficulty in Falling Asleep and Staying Asleep

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zaleplon
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014