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

NCT00878553 | Completed Phase 2 Results

• 1 other identifier: SOM201
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Disorder; Primary Insomnia

Keywords

insomnia; middle of the night; sleep maintenance

Outcome Measures

Primary Outcomes (1)

• Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)

  Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.

  Hours 3-7 (inclusive) after tablet ingestion

Secondary Outcomes (13)

• WASO 1-8

  Constantly throughout the 8 hour sleep period

• Total Sleep Time 3-7 Hours Post-dose

  hours 3-7 (inclusive) post-dose

• Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)

  hours 3-7 (inclusive) post-dose

• Subjective Wake Time After Sleep Onset (sWASO)

  9 hours after tablet ingestion

• Digit Symbol Substitution Test

  9 hours after tablet ingestion

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

10 mg SKP-1041

EXPERIMENTAL

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

Drug: SKP-1041 (experimental formulation of zaleplon)

15 mg SKP-1041

EXPERIMENTAL

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

Drug: SKP-1041 (experimental formulation of zaleplon)

20 mg SKP-1041

EXPERIMENTAL

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

Drug: SKP-1041 (experimental formulation of zaleplon)

Interventions

placebo DRUG

tablet at bedtime

Also known as: sugar pill

Placebo

SKP-1041 (experimental formulation of zaleplon) DRUG

tablet at bedtime

Also known as: zaleplon

10 mg SKP-1041; 15 mg SKP-1041; 20 mg SKP-1041

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary insomnia characterized by chronic difficulty maintaining sleep

You may not qualify if:

• 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.

Sponsors & Collaborators

• Somnus Therapeutics, Inc.: lead
• INC Research Limited: collaborator

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Sugars; zaleplon

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

Questionnaires focused on initial insomnia as opposed to middle of the night awakening, short exposure to each dose, and lengthy washout periods between doses, may not allow for ideal assessment of subjective response to treatment.

Results Point of Contact

• Title: Dr. Christine Blumhardt, Chief Regulatory Officer
• Organization: Somnus Therapeutics, Inc

cblumhardt@somnusthera.com

617-710-0928

Study Officials

• Jon Freeman, PhD

  Clinilabs, Inc.

  PRINCIPAL INVESTIGATOR

• Steven G. Hull, MD

  Vince and Associates Clinical Research

  PRINCIPAL INVESTIGATOR

• Russell Rosenberg, PhD

  Neurotrials Inc.

  PRINCIPAL INVESTIGATOR

• James K. Walsh, PhD

  Sleep Medicine and Research Center

  PRINCIPAL INVESTIGATOR

• David J. Seiden, MD

  Broward Research Group

  PRINCIPAL INVESTIGATOR

• Helene A. Emsellem, MD

  Emsellem MD PC

  PRINCIPAL INVESTIGATOR

• D. Alan Lankford, PhD

  Sleep Disorders Center of Georgia

  PRINCIPAL INVESTIGATOR

• Beth E. Safirstein, MD

  MD Clinical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: April 9, 2009
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: February 1, 2013
• Results First Posted: February 1, 2013

Record last verified: 2013-01