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Phase 3 Clinical Study of CN-801 in patients with idiopathic hypersomnia

Phase 3 Clinical Study of CN-801 - Double-blind comparative study in patients with excessive daytime sleepiness associated with idiopathic hypersomnia -

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222488
Enrollment
Unknown
Registered
2014-05-22
Start date
2014-05-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic hypersomnia

Interventions

investigational material(s) Generic name etc : CN-801 INN of investigational material : modafinil Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational mate

Sponsors

Alfresa Pharma Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnosis of idiopathic hypersomnia based on the International Classification of Sleep Disorders, second edition (ICSD-2)

Exclusion criteria

Exclusion criteria: Patients with narcolepsy, restless legs syndrome, periodic limb movement disorder, or sleep apnea syndrome Patients working irregular shifts or night shifts Patients with chronic sleep deprivation or patients with extremely irregular bed times

Design outcomes

Primary

MeasureTime frame
Efficacy (Mean sleep latency in MWT)—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026