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

Somnus Therapeutics

Status and phase: Completed; Phase 2

Conditions: Sleep Disorder; Primary Insomnia

Treatments: Drug: SKP-1041 (experimental formulation of zaleplon); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878553

SOM201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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67 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

10 mg SKP-1041

Experimental group

Description:

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

Treatment:

Drug: SKP-1041 (experimental formulation of zaleplon)

15 mg SKP-1041

Experimental group

Description:

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

Treatment:

Drug: SKP-1041 (experimental formulation of zaleplon)

20 mg SKP-1041

Experimental group

Description:

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

Treatment:

Drug: SKP-1041 (experimental formulation of zaleplon)