Clinical Trial: Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open Label, Dose Escalation Study With A Double Blind Randomised Placebo Controlled Withdrawal To Examine The Effects Of The Histamine H3 Antagonist GSK189254 In Patients With

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

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Sleep latency (in minutes), as measured by the Maintenance of Wakefulness Test (MWT), at the end of the DBP [ Time Frame: Day 42 ]

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.


Original Primary Outcome: Sleep Latency as measured by the Maintenance of Wakefulness test (this test evaluates alertness and tendency to stay awake or fall asleep at inappropriate times).

Current Secondary Outcome:

  • Change from baseline in Sleep latency (minutes), as measured by the MWT for the OLP [ Time Frame: Baseline (Day -1) and Day 28 ]
    Sleep latency was measured for OLP (Day 28) 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. Baseline was defined at Visit 1 (Day -1). Change from baseline was calculated by subtracting the value on Day -1 minus the value on 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) [ Time Frame: Day 28 and Day 42 ]
    Sleep latency was measured 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. Last assessed value of OLP (Day 28) value was used as baseline value for DBP. Change from end of OLP was calculated by subtracting the value on Day 28 minus the value on Day 42. Least square mean was used to present the value for adjusted mean.
  • Change from Baseline in Frequency of Cataplexy Attacks during the OLP [ Time Frame: Baseline (Day -1) up to Day 28 ]
    Narcolepsy was classically described as excessive daytime sleepiness in association with emotionally triggered episodes of muscle weakness, known as cataplexy. Forms of narcolepsy exist without cataplexy which varies in severity from barely perceptible loss of tone of the facial muscles to total collapse. The number of daily cataplexy attacks (frequency) was estimated and recorded in the diary card. Baseline was defined at Visit 1 (Day -1). Change from baseline was calculated by subtracting the value on Day -1 minus the value on Day 1-6, 7-13, 14-20, 21-29.
  • Change from Baseline in severity of Cataplexy Attacks during the OLP [ Time Frame: Baseline (Day -1) up to Day 28 ]
    Narcolepsy was classically described as excessive daytime sleepiness in association with emotionally triggered episodes of muscle weakness, known as cataplexy. Forms of narcolepsy exist without cataplexy which varies in severity from barely perceptible loss of tone of the facial muscles to total collapse. The overall severity of the attacks was rated at the end of each day using a visual analogue scale (VAS) with the following the anchor points: When considering the narcolepsy symptoms for today, overall how severe were the cataplexy Attacks- Not troublesome, e.g. infrequent and/ or had minimal effect on mobility or Very severe, e.g. of high frequency and /or severely debilitating in mobility. Baseline was defined at Visit 1 (Day -1). Change from baseline was calculated by subtracting the value on Day -1 minus the value on Day 1-6, 7-13, 14-20, 21-29.
  • Change from End of OLP (Day 28) in Frequency of Cataplexy Attacks during the DBP [ Time Frame: Day 28 up to Day 42 ]
    Narcolepsy was classically described as excessive daytime sleepiness in association with emotionally triggered episodes of muscle weakness, known as cataplexy. Forms of narcolepsy exist without cataplexy which varies in severity from barely perceptible loss of tone of the facial muscles to total collapse. The number of daily cataplexy attacks was estimated and recorded in the diary card. Last assessed value of OLP (Day 28) value was used as baseline value for DBP. Change from end of OLP was calculated by subtracting the value on Day 28 minus the value on Day 30-35 and 36-42. Least square mean was used to present the value for adjusted mean.
  • Change from End of OLP (Day 28) in severity of Cataplexy Attacks during the DBP [ Time Frame: Day 28 up to Day 42 ]
    Narcolepsy was classically described as excessive daytime sleepiness in association with emotionally triggered episodes of muscle weakness, known as cataplexy. Forms of narcolepsy exist without cataplexy which varies in severity from barely perceptible loss of tone of the facial muscles to total collapse . The number of daily cataplexy attacks was estimated and recorded in the diary card. Last assessed value of OLP (Day 28) value was used as baseline value for DBP. Change from end of OLP was calculated by subtracting the value on Day 28 minus the value on Day 30-35 and Day 36-42. Least square mean was used to present the value for adjusted mean.
  • Change from Baseline in Severity of Nocturnal Symptoms during the OLP [ Time Frame: Baseline (Day -1) up to Day 28 ]
    Participants kept a daily diary card to record the severity of nocturnal narcolepsy symptoms. The overall severity of the nocturnal symptoms was rated at the end of each day using a VAS. In the morning, upon waking and at the time they took their morning dose participants we

    Original Secondary Outcome:

    • Frequency and severity of cataplexy attacks
    • Severity of nocturnal disease symptoms
    • Sleep Evaluation Scales
    • Improvement scales
    • Safety & Tolerability


    Information By: GlaxoSmithKline

    Dates:
    Date Received: August 17, 2006
    Date Started: November 2006
    Date Completion:
    Last Updated: March 9, 2017
    Last Verified: March 2017