NCT00426816

Brief Summary

This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 13, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

January 23, 2007

Last Update Submit

August 9, 2012

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

primary insomniaPSG sleep recordingsdaytime cognitive functionInsomniaSB-649868

Outcome Measures

Primary Outcomes (1)

  • Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording.

    Statistical paramaters of sleep measured by analysis of Polysomnography during night section of subject visit. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up.

    9 weeks

Secondary Outcomes (6)

  • Objective PSG measures of sleep continuity including: wake during sleep (WDS), wake after sleep (WAS), and number of awakenings during sleep. Objective PSG measures of sleep structure

    9 weeks

  • Objective PSG measures of sleep structure: Non-REM sleep time, Slow-Wave Sleep (SWS) time (stage 3 and 4), Stage 2 non-REM sleep time; REM sleep time, REM activity, REM density.

    9 weeks

  • Spectral analysis of EEG

    9 weeks

  • Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording.

    9 weeks

  • Daytime cognitive function data on the morning following dosing, including tests of alertness, memory, attention and fine motor control (i.e. Romberg, VAS for sleepiness/alertness, DSST, and immediate and delayed word recall).

    9 weeks

  • +1 more secondary outcomes

Study Arms (1)

Crossover population

EXPERIMENTAL

All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing

Drug: SB-649868Drug: Placebo

Interventions

SB-649868DRUG

Active compound at doses of 10mg, 30mg and 60mg

Crossover population
PlaceboDRUG

Placebo to match SB-649868

Crossover population

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • years of age (inclusive),
  • Diagnosis of primary insomnia who have had symptoms for at least three months.

You may not qualify if:

  • Any clinically significant unstable medical or surgical condition (treated or untreated).
  • Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

GSK Investigational Site

Cottbus, Brandenburg, 03050, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 20249, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

GSK Investigational Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13125, Germany

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

N-((1-((5-(4-fluorophenyl)-2-methyl-4-thiazolyl)carbonyl)-2-piperidinyl)methyl)-4-benzofurancarboxamide

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

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

January 23, 2007

First Posted

January 25, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 13, 2012

Record last verified: 2012-08

Locations

DE(10)