NCT00366080

Brief Summary

The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Geographic Reach
6 countries

14 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

August 17, 2006

Last Update Submit

March 9, 2017

Conditions

Narcolepsy

Keywords

GSK189254 H3 Histamine Narcolepsy

Outcome Measures

Primary Outcomes (1)

  • Sleep latency (in minutes), as measured by the Maintenance of Wakefulness Test (MWT), at the end of the DBP

    Sleep latency was measured at the end of DBP (Day 42) by an extended version of the MWT which was used to measure the ability of a participant to remain awake. The MWT consisted of four 40-minutes trails performed at two hour intervals and the main MWT score was mean sleep latency (arithmetic mean of the four 40-minutes trials). Trials were ended after 40 minutes if no sleep occurred, or after unequivocal sleep, defined as three consecutive epochs of stage 1 sleep, or one epoch of any other stage of sleep. Least square mean was used to present the value for adjusted mean.

    Day 42

Secondary Outcomes (54)

  • Change from baseline in Sleep latency (minutes), as measured by the MWT for the OLP

    Baseline (Day -1) and Day 28

  • Change from End of OLP (Day 28) in Sleep latency (minutes), as measured by the MWT to the end of the DBP (Day 42)

    Day 28 and Day 42

  • Change from Baseline in Frequency of Cataplexy Attacks during the OLP

    Baseline (Day -1) up to Day 28

  • Change from Baseline in severity of Cataplexy Attacks during the OLP

    Baseline (Day -1) up to Day 28

  • Change from End of OLP (Day 28) in Frequency of Cataplexy Attacks during the DBP

    Day 28 up to Day 42

  • +49 more secondary outcomes

Interventions

GSK189254DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Narcolepsy patients
  • Body mass index between 18 - 32 kg/m2
  • Females may be of child bearing or non-child bearing potential.
  • Agreement to refrain from driving or operating heavy machinery for the duration of the study.
  • Must be able to withdraw from medication for the treatment of daytime sleepiness and must not be living on their own.

You may not qualify if:

  • History or presence of major psychiatric disorder or depression.
  • History of significant head trauma in the previous 12 months.
  • Participation in a clinical trial in the previous 3 months.
  • Patient has significant and recent (within 1 year) history of drug or alcohol abuse.
  • Patient is pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

GSK Investigational Site

Innsbruck, A-6020, Austria

Location

GSK Investigational Site

Vienna, A-1190, Austria

Location

GSK Investigational Site

Espoo, 02980, Finland

Location

GSK Investigational Site

Regensburg, Bavaria, 93053, Germany

Location

GSK Investigational Site

Schwalmstadt, Hesse, 34613, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44789, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14050, Germany

Location

GSK Investigational Site

Leiden, 2333 CL, Netherlands

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Cambridge, Cambridgeshire, CB3 8RE, United Kingdom

Location

GSK Investigational Site

London, London, W1G 6BF, United Kingdom

Location

GSK Investigational Site

Edinburgh, EH3 6HP, United Kingdom

Location

MeSH Terms

Conditions

Narcolepsy

Interventions

6-((3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy)-N-methyl-3-pyridinecarboxamide

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep 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
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

November 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

GB(3)FI(1)NL(1)AU(2)DE(5)ES(2)