Narcolepsy with Cataplexy (Narcolepsy Type 1)
Conditions
Brief summary
Change from baseline to Week 12 in ESS total score
Detailed description
Change from baseline to Week 12 in mean sleep latency from the 4 MWT wake trials., WCR at Week 12, Change from baseline to Week 12 in mean number of lapses on the PVT, PGI-C score at Week 12., Change from baseline to Week 12 in NSS-CT total score, Change from baseline to Week 12 in FINI domain scores for: Tiredness, Cognitive Functioning, Cataplexy, Social Activities, Everyday Activities, and Everyday Responsibilities., Change from baseline to Week 12 in SF-36 mental and physical component summary scores, Occurrence of at least 1 TEAE during the study including the follow-up period, as applicable
Interventions
Sponsors
Takeda Development Center Americas Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in ESS total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in mean sleep latency from the 4 MWT wake trials., WCR at Week 12, Change from baseline to Week 12 in mean number of lapses on the PVT, PGI-C score at Week 12., Change from baseline to Week 12 in NSS-CT total score, Change from baseline to Week 12 in FINI domain scores for: Tiredness, Cognitive Functioning, Cataplexy, Social Activities, Everyday Activities, and Everyday Responsibilities., Change from baseline to Week 12 in SF-36 mental and physical component summary scores, Occurrence of at least 1 TEAE during the study including the follow-up period, as applicable | — |
Countries
France, Germany, Italy, Netherlands, Norway, Spain
Outcome results
None listed