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

NCT01277107 | Completed Phase 2 DMC

• 1 other identifier: IN 09 006
• Study Type: interventional
• Target: 83
• Locations: 2 countries
• Sites: 6

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.

Conditions

Insomnia

Keywords

PSG; LPS; TST; WASO; Subjects With Insomnia characterized by both Difficulty in Falling Asleep and Staying Asleep

Outcome Measures

Primary Outcomes (1)

• 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.

  Polysomnography tests for 2 consecutive nights at each treatment arm

Secondary Outcomes (3)

• To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS)

  Polysomnography tests for 2 consecutive nights at each treatment arm

• To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO)

  Polysomnography tests for 2 consecutive nights at each treatment arm

• 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

Study Arms (2)

Zaleplon AP formulation

EXPERIMENTAL

Gastric Retentive Dual Release Zaleplon (Zaleplon AP)

Drug: Zaleplon AP formulation

Placebo

PLACEBO COMPARATOR

Identical placebo capsule

Drug: Placebo capsule

Interventions

Zaleplon AP formulation DRUG

Gastric retentive dual release Zaleplon

Zaleplon AP formulation

Placebo capsule DRUG

Identical placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Intec Pharma Ltd.: lead

Study Sites (6)

Pacific Sleep Medicine

San Diego, California, United States

Location

Miami Research Associates

Miami, Florida, United States

Location

Broward Research Group

Pembroke Pines, Florida, United States

Location

CRG of St. Petersburg

St. Petersburg, Florida, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Location

Rambam sleep center

Haifa, Israel

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 14, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (5); IL (1)