Study of Sleep-maintenance Activity of 3 Doses of SKP-1041

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-08-31

Brief Summary

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SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.

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Detailed Description

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Patients will participate in the study for approximately 44 to 56 days, including a 14- to 21-day Screening Period, 4 Treatment Periods each followed by washout periods, and a final Follow-up Visit. Patients will receive their randomly assigned study medication and spend 2 nights in a sleep laboratory, subsequently returning home for a 4- to 7-day washout period between each treatment period. The fourth and final treatment period will include a third night at the site during which all patients will continue to receive the same study medication as on the first 2 nights of this treatment period. Blood will be drawn from all patients for pharmacokinetic analyses at specific time intervals. Patients will undergo final safety assessments 2 to 5 days after the last dose of study medication.

Conditions

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Sleep Disorder Primary Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Two placebo tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablet at bedtime

10 mg SKP-1041

One 10 mg SKP-1041 controlled release zaleplon tablet plus one placebo tablet administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence

Group Type EXPERIMENTAL

SKP-1041 (experimental formulation of zaleplon)

Intervention Type DRUG

tablet at bedtime

15 mg SKP-1041

One 15 mg SKP-1041 controlled release zaleplon tablet plus one placebo tablet administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence

Group Type EXPERIMENTAL

SKP-1041 (experimental formulation of zaleplon)

Intervention Type DRUG

tablet at bedtime

20 mg SKP-1041

Two 10 mg SKP-1041 controlled release zaleplon tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence

Group Type EXPERIMENTAL

SKP-1041 (experimental formulation of zaleplon)

Intervention Type DRUG

tablet at bedtime

Interventions

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placebo

tablet at bedtime

Intervention Type DRUG

SKP-1041 (experimental formulation of zaleplon)

tablet at bedtime

Intervention Type DRUG

Other Intervention Names

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sugar pill zaleplon

Eligibility Criteria

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Inclusion Criteria

* Primary insomnia characterized by chronic difficulty maintaining sleep

Exclusion Criteria

* History of restless legs syndrome, sleep apnea, narcolepsy, or parasomnias;
* Any clinically relevant acute or chronic diseases which could interfere with the patient's safety during this trial or with this tablet's absorption;
* Pregnancy;
* History of medication allergies;
* Use of medication that might interfere with this study;
* Recent travel across more than 3 time zones.

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No