Phase 2
N=95
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Excessive Daytime Sleepiness · Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT01006122 ↗Enrolled (actual)
95
Serious AEs
1.3%
Results posted
May 2014
Primary outcome: Primary: Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase — 6.30; 5.81; 1.29; 1.10 minutes — p=0.418
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); PF-03654746 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase |
6.30; 5.81; 1.29; 1.10 | 0.418 |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase |
16.54; 16.32; -2.06; -0.74; -2.00; -1.16 | 0.054 |
| SECONDARY Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase |
5.01; 5.02; -1.02; -0.77; -0.85; -0.88 | 0.121 |
| SECONDARY Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase |
5.71; 5.92; -1.91; -2.67; -1.71; -2.63 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase |
79.68; 80.38; 61.20; 65.19; 68.97; 73.89 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) Scale Score |
3.51; 3.75; 3.48; 3.61; 3.36; 3.35 | 0.127 |
| SECONDARY Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT) |
48.71; 53.19; 48.49; 48.32; 44.88; 43.59 | — |
| SECONDARY Computer Based Objective Cognition Testing (CogState) Detection Speed |
2.55; 2.55; 2.51; 2.52; 2.52; 2.52 | — |
| SECONDARY Computer Based Objective Cognition Testing (CogState) Identification Speed |
2.74; 2.72; 2.72; 2.72; 2.72; 2.73 | — |
| SECONDARY Computer Based Objective Cognition Testing (CogState) One Card Learning |
1.01; 1.02; 1.01; 1.02; 1.01; 1.02 | — |
| SECONDARY Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL) |
48.42; 46.4; 37.18; 37.01; 36.64; 30.54 | — |
| SECONDARY Computer Based Objective Cognition Testing (CogState ) Composite Score |
0.02; 0.06; 0.19; 0.19; 0.21; 0.23 | — |
Summary
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this compound compared to placebo in patients with narcolepsy is hypothesized.
Eligibility Criteria
Inclusion Criteria
- ISDC diagnosis of narcolepsy
- Excessive Daytime Sleepiness in association with a diagnosis of narcolepsy
- An MWT (Maintenance of Wakefulness Test) average sleep latency of under 15 minutes at Baseline
Exclusion Criteria
- No other diagnosed sleep disorders (e.g., sleep apnea)
- Major medical disorders
- Major psychiatric disorders
Data sourced from ClinicalTrials.gov (NCT01006122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.