A Long-term Extension Study of the Safety and Efficacy of Cleminorexton in Participants with Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored Cleminorexton Clinical Trial

Condition studied

Narcolepsy and Idiopathic Hypersomnia

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence, severity, and causal relationship of treatment emergent adverse events (TEAEs), including serious TEAEs, Changes from baseline in laboratory tests, including biochemistry, hematology, and urinalysis, Changes from baselinea in vital signs and weight, Changes from baseline in 12-lead electrocardiograms (ECGs), Columbia-Suicide Severity Rating Scale (C-SSRS) scores

Endpoint detail

PK: - Predose and post dose PK concentrations of Cleminorexton- Other PK parameters as appropriate, Efficacy: o Mean sleep latency (changes from baseline to specific postdose timepoints) in the MWT (average of the first 4 trials), conducted for NT1 and NT2 participants only. o Subjective daytime sleepiness (changes from baseline to specified post dose timepoints) using the ESS