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 Narcolepsy.

GlaxoSmithKline1 site in 1 country69 target enrollmentNovember 2006

ConditionsNarcolepsy

DrugsGSK189254

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Narcolepsy
Sponsor: GlaxoSmithKline
Enrollment: 69
Locations: 1
Primary Endpoint: Sleep latency (in minutes), as measured by the Maintenance of Wakefulness Test (MWT), at the end of the DBP
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

January 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change from Baseline in severity of Cataplexy Attacks during the OLP(Baseline (Day -1) up to Day 28)
Change from Baseline in Severity of Nocturnal Symptoms during the OLP(Baseline (Day -1) up to Day 28)
Change from Baseline in Frequency of Cataplexy Attacks during the OLP(Baseline (Day -1) up to Day 28)
Change from End of OLP (Day 28) in severity of Cataplexy Attacks during the DBP(Day 28 up to Day 42)
Change from Baseline in duration of Daytime Naps (Based on Actigraphy) during the OLP(Baseline up to Day 28)
Change from End of OLP (Day 28) in Frequency of Daytime Naps (Based on Actigraphy) during the DBP(Day 28 up to Day 42)
Change from baseline in Sleep latency (minutes), as measured by the MWT for the OLP(Baseline (Day -1) and Day 28)
Number of participants with abnormal electrocardiogram (ECG) findings at any time during OLP(Up to Day 28)
Number of participants with abnormal ECG findings during DBP(Day 42)
Change from Baseline in Nocturnal PSG for the DBP- Frequency of awakening(Baseline (Day -1) and Day 42)
Number of participants with shift from baseline in Haematology parameters of PCI for DBP(Baseline (Day 1) up to Day 42)
Number of participants with AEs and SAEs in the DBP(Up to Day 42)
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 End of OLP (Day 28) on the Epworth Sleepiness Scale (ESS) to the End of DBP (Day 42)(Day 28 up to Day 42)
Change from End of OLP (Day 28) in duration of Daytime Naps (Based on Actigraphy) during the DBP(Day 28 up to Day 42)
Change from Baseline in Time (min) until Sleep Onset REM (rapid eye moment) (SOREM) during the OLP(Baseline (Day -1) up to Day 28)
Change from End of OLP in Time (min) until SOREM to the End of DBP(Day 28 and Day 42)
Change from Baseline in POMS-B Domain Scores for the DBP(Baseline (Day -1) up to Day 42)
Change from End of OLP (Day 28) in Frequency of Cataplexy Attacks during the DBP(Day 28 up to Day 42)
Change from End of OLP (Day 28) in Severity of Nocturnal Symptoms during the DBP(Day 28 up to Week 42)
Change from Baseline in the Leeds Sleep Evaluation Questionnaire (LSEQ) during the OLP(Baseline (Day -1) up to Day 28)
Change from End of OLP in the LSEQ during the DBP(Day 28 up to Day 42)
Change from Baseline in Frequency of Daytime Naps (Based on Actigraphy) during the OLP(Baseline up to Day 28)
Number of participants who responded to open-label treatment on Day 28(Day 28)
Number of participants with Improved assessment of illness on day 14 and 28 as measured by the Patient Global Impression of Change (PGIC) and by the Clinician Global Impression of Change (CGIC)(Day 14 and 28)
Change from Baseline in number of errors on the DVT to the End of OLP (Day 28)(Baseline (Day -1), Day 14 and Day 28)
Assessment of Nocturnal Actigraphy for the DLP- Average actual sleep time, Average actual wake time, Average sleep latency duration(Up to Day 42)
Change from Baseline in Nocturnal PSG for the OLP- Sleep onset latency, Sleep period time, total Stage 1, 2, 3, 4 duration(Baseline (Day -1) up to Day 28)
Change from Baseline in Nocturnal PSG for the DBP- Time in bed, Total sleep time, WDS from SO to final epoch of sleep(Baseline (Day -1) and Day 42)
Number of participants with shift from Baseline in clinical chemistry parameters of PCI for DBP(Baseline (Day 1) up to Day 42)
Number of participants with Improved assessment of illness on day 42 as measured by the PGIC and by the CGIC(Day 42)
Change from baseline in Vital Signs for the OLP- Systolic blood pressure and diastolic blood pressure(Baseline (Day 1) up to Day 28)
Change from baseline in Vital Signs for the OLP- Heart rate (HR)(Baseline (Day 1) up to Day 28)
Change from Baseline in Nocturnal PSG for the OLP- Frequency of awakening(Baseline (Day -1) up to Day 28)
Change from Baseline in Nocturnal PSG for the DBP- total movement time, REM-D, REM-D in first, second, third and fourth quarter of sleep, REM latency(Baseline (Day -1) and Day 42)
Change from Baseline in Nocturnal PSG for the DBP- Sleep efficiency(Baseline (Day -1) and Day 42)
Change from Baseline in Nocturnal PSG for the DBP- Sleep onset latency, Sleep period time, total Stage 1, 2, 3, 4 duration(Baseline (Day -1) and Day 42)
Change from Baseline in Time (min) required to complete the Digit Vigilance Test (DVT) during the OLP(Baseline (Day -1) up to Day 28)
Change from End of OLP in Time (min) Required to Complete the DVT during the DBP (Day 42)(Day 28 and Day 42)
Change from End of OLP (Day 28) in number of errors on the DVT to the End of DBP (Day 42)(Day 28 and Day 42)
Change from baseline in Vital Signs for the DBP- Systolic blood pressure and diastolic blood pressure(Baseline (Day 1) and Day 42)
Change from baseline in Vital Signs for the DBP- HR(Baseline (Day 1) and Day 42)
Change from Baseline in Profile of Mood State (POMS-B) Domain Scores for the OLP(Baseline (Day -1) up to Day 28)
Assessment of Nocturnal Actigraphy for the OLP- Average sleep efficiency(Up to Day 28)
Change from Baseline in Nocturnal PSG for the OLP- Sleep efficiency(Baseline (Day -1) up to Day 28)
Change from Baseline in Nocturnal PSG for the OLP- Time in bed, Total sleep time, Wake during sleep (WDS) from first epoch of sleep (SO) to final epoch of sleep(Baseline (Day -1) up to Day 28)
Assessment of Nocturnal Actigraphy for the OLP- Average actual sleep time, Average actual wake time, Average sleep latency duration(Day 28)
Assessment of Nocturnal Actigraphy for the DLP- Average sleep efficiency(Up to Day 42)
Change from Baseline in Nocturnal PSG for the OLP- total movement time, REM duration (REM-D), REM-D in first, second, third and fourth quarter of sleep, REM latency(Baseline (Day -1) up to Day 28)
Number of participants with adverse events (AEs) and serious adverse events (SAEs) in the OLP(Up to Day 28)
Number of participants with shift from Baseline in haematology parameters of potential clinical importance (PCI) for OLP(Baseline (Day 1) up to Day 28)
Number of participants with shift from baseline in clinical chemistry parameters of PCI for OLP(Baseline (Day 1) up to day 28)
Number of participants with abnormal urinalysis results for the OLP(Up to Day 28)
Number of participants with abnormal urinalysis results for the DBP(Day 42)