A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
Suven Life Sciences Limited
Study ID
NCT07540364
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Samelisant — DRUG
    Tablet dosage form, once a day
  • Placebo — DRUG
    Matching placebo tablets, once a day

Study Details

The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the individual remains conscious. Other objectives include examining the impact of Samelisant on attention and alertness, overall quality of life, the spectrum of narcolepsy symptoms, and daily functioning, as well as evaluating its safety profile.

Key Dates

First listed
Apr 20, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Nov 19, 2027
Completion
Dec 19, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Samelisant Tablets
  • Placebo Comparator: Placebo Tablets

Primary Outcome Measure

Change from Baseline in total Epworth Sleepiness Scale (ESS) score at Week 12 [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bogan Sleep ConsultantsColumbiaSouth Carolina29201-

Find similar trials in Columbia, SC

By research site
Bogan Sleep Consultants· Columbia, SC

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