Clinical trial NCT00366080: Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
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 Narcolepsy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Narcolepsy
Keywords: GSK189254 H3 Histamine Narcolepsy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-18
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Sleep latency (in minutes), as measured by the Maintenance of Wakefulness Test (MWT), at the end of the DBP
timeFrame: Day 42
Secondary outcomes:
measure: Change from baseline in Sleep latency (minutes), as measured by the MWT for the OLP
timeFrame: Baseline (Day -1) and Day 28
measure: Change from End of OLP (Day 28) in Sleep latency (minutes), as measured by the MWT to the end of the DBP (Day 42)
timeFrame: Day 28 and Day 42
measure: Change from Baseline in Frequency of Cataplexy Attacks during the OLP
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from Baseline in severity of Cataplexy Attacks during the OLP
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from End of OLP (Day 28) in Frequency of Cataplexy Attacks during the DBP
timeFrame: Day 28 up to Day 42
measure: Change from End of OLP (Day 28) in severity of Cataplexy Attacks during the DBP
timeFrame: Day 28 up to Day 42
measure: Change from Baseline in Severity of Nocturnal Symptoms during the OLP
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from End of OLP (Day 28) in Severity of Nocturnal Symptoms during the DBP
timeFrame: Day 28 up to Week 42
measure: Change from End of OLP (Day 28) on the Epworth Sleepiness Scale (ESS) to the End of DBP (Day 42)
timeFrame: Day 28 up to Day 42
measure: Change from Baseline in the Leeds Sleep Evaluation Questionnaire (LSEQ) during the OLP
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from End of OLP in the LSEQ during the DBP
timeFrame: Day 28 up to Day 42
measure: Change from Baseline in Frequency of Daytime Naps (Based on Actigraphy) during the OLP
timeFrame: Baseline up to Day 28
measure: Change from Baseline in duration of Daytime Naps (Based on Actigraphy) during the OLP
timeFrame: Baseline up to Day 28
measure: Change from End of OLP (Day 28) in Frequency of Daytime Naps (Based on Actigraphy) during the DBP
timeFrame: Day 28 up to Day 42
measure: Change from End of OLP (Day 28) in duration of Daytime Naps (Based on Actigraphy) during the DBP
timeFrame: Day 28 up to Day 42
measure: Number of participants who responded to open-label treatment on Day 28
timeFrame: Day 28
measure: Change from Baseline in Time (min) until Sleep Onset REM (rapid eye moment) (SOREM) during the OLP
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from End of OLP in Time (min) until SOREM to the End of DBP
timeFrame: Day 28 and Day 42
measure: 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)
timeFrame: Day 14 and 28
measure: Number of participants with Improved assessment of illness on day 42 as measured by the PGIC and by the CGIC
timeFrame: Day 42
measure: Change from Baseline in Time (min) required to complete the Digit Vigilance Test (DVT) during the OLP
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from End of OLP in Time (min) Required to Complete the DVT during the DBP (Day 42)
timeFrame: Day 28 and Day 42
measure: Change from Baseline in number of errors on the DVT to the End of OLP (Day 28)
timeFrame: Baseline (Day -1), Day 14 and Day 28
measure: Change from End of OLP (Day 28) in number of errors on the DVT to the End of DBP (Day 42)
timeFrame: Day 28 and Day 42
measure: Change from baseline in Vital Signs for the OLP- Systolic blood pressure and diastolic blood pressure
timeFrame: Baseline (Day 1) up to Day 28
measure: Change from baseline in Vital Signs for the DBP- Systolic blood pressure and diastolic blood pressure
timeFrame: Baseline (Day 1) and Day 42
measure: Change from baseline in Vital Signs for the OLP- Heart rate (HR)
timeFrame: Baseline (Day 1) up to Day 28
measure: Change from baseline in Vital Signs for the DBP- HR
timeFrame: Baseline (Day 1) and Day 42
measure: Number of participants with abnormal electrocardiogram (ECG) findings at any time during OLP
timeFrame: Up to Day 28
measure: Number of participants with abnormal ECG findings during DBP
timeFrame: Day 42
measure: Change from Baseline in Profile of Mood State (POMS-B) Domain Scores for the OLP
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from Baseline in POMS-B Domain Scores for the DBP
timeFrame: Baseline (Day -1) up to Day 42
measure: Assessment of Nocturnal Actigraphy for the OLP- Average actual sleep time, Average actual wake time, Average sleep latency duration
timeFrame: Day 28
measure: Assessment of Nocturnal Actigraphy for the OLP- Average sleep efficiency
timeFrame: Up to Day 28
measure: Assessment of Nocturnal Actigraphy for the DLP- Average actual sleep time, Average actual wake time, Average sleep latency duration
timeFrame: Up to Day 42
measure: Assessment of Nocturnal Actigraphy for the DLP- Average sleep efficiency
timeFrame: Up to Day 42
measure: Change from Baseline in Nocturnal PSG for the OLP- Frequency of awakening
timeFrame: Baseline (Day -1) up to Day 28
measure: 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
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from Baseline in Nocturnal PSG for the OLP- Sleep efficiency
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from Baseline in Nocturnal PSG for the OLP- Sleep onset latency, Sleep period time, total Stage 1, 2, 3, 4 duration
timeFrame: Baseline (Day -1) up to Day 28
measure: 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
timeFrame: Baseline (Day -1) up to Day 28
measure: Change from Baseline in Nocturnal PSG for the DBP- Frequency of awakening
timeFrame: Baseline (Day -1) and Day 42
measure: 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
timeFrame: Baseline (Day -1) and Day 42
measure: Change from Baseline in Nocturnal PSG for the DBP- Sleep efficiency
timeFrame: Baseline (Day -1) and Day 42
measure: Change from Baseline in Nocturnal PSG for the DBP- Sleep onset latency, Sleep period time, total Stage 1, 2, 3, 4 duration
timeFrame: Baseline (Day -1) and Day 42
measure: Change from Baseline in Nocturnal PSG for the DBP- Time in bed, Total sleep time, WDS from SO to final epoch of sleep
timeFrame: Baseline (Day -1) and Day 42
measure: Number of participants with shift from Baseline in haematology parameters of potential clinical importance (PCI) for OLP
timeFrame: Baseline (Day 1) up to Day 28
measure: Number of participants with shift from baseline in Haematology parameters of PCI for DBP
timeFrame: Baseline (Day 1) up to Day 42
measure: Number of participants with shift from baseline in clinical chemistry parameters of PCI for OLP
timeFrame: Baseline (Day 1) up to day 28
measure: Number of participants with shift from Baseline in clinical chemistry parameters of PCI for DBP
timeFrame: Baseline (Day 1) up to Day 42
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) in the OLP
timeFrame: Up to Day 28
measure: Number of participants with AEs and SAEs in the DBP
timeFrame: Up to Day 42
measure: Number of participants with abnormal urinalysis results for the OLP
timeFrame: Up to Day 28
measure: Number of participants with abnormal urinalysis results for the DBP
timeFrame: Day 42
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Schwalmstadt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Leiden
country: Netherlands
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: