Narcolepsy Type 1, Type 2 and Idiopathic Hypersomnia
Conditions
Brief summary
Treatment-emergent adverse events (TEAEs)
Detailed description
Clinical laboratory assessments, Vital signs, Safety electrocardiogram (ECG), Columbia-Suicide Severity Rating Scale (C-SSRS), Change in the MSL on MWT from baseline to Week 24 (for NT1 and NT2 subjects only), Change in Epworth Sleepiness Scale (ESS) from baseline through the Treatment Period, Change in the weekly cataplexy rate (WCR) from baseline through the Treatment Period (for NT1 subjects only), Change in IHSS from baseline through the Treatment Period (for IH subjects only)
Interventions
DRUGALKS 2680
Sponsors
Alkermes Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events (TEAEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical laboratory assessments, Vital signs, Safety electrocardiogram (ECG), Columbia-Suicide Severity Rating Scale (C-SSRS), Change in the MSL on MWT from baseline to Week 24 (for NT1 and NT2 subjects only), Change in Epworth Sleepiness Scale (ESS) from baseline through the Treatment Period, Change in the weekly cataplexy rate (WCR) from baseline through the Treatment Period (for NT1 subjects only), Change in IHSS from baseline through the Treatment Period (for IH subjects only) | — |
Countries
Belgium, Czechia, France, Italy, Netherlands, Spain
Outcome results
None listed