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Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy

An Intermediate-size, Expanded Access to SUVN-G3031 for the Treatment of Subjects With Narcolepsy Who Have Completed the CTP2S13031H3 Protocol

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05530447
Enrollment
Unknown
Registered
2022-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-09-23

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

Conditions

Narcolepsy

Brief summary

The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well as the subject believe that the benefits outweigh the risks to continue the treatment with SUVN-G3031.

Detailed description

The qualified subjects will be given 2mg of SUVN-G3031 expanded access treatment for 30 days. At the end of 30 days if the subject wishes to continue the treatment, he/she will be provided with adequate investigational drug for next 30 days. This cycle will be repeated up to a maximum of 2 times (total duration of expanded access treatment up to 90 days).

Interventions

DRUGSamelisant

Tablet

Sponsors

Suven Life Sciences Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

1. Subjects who have completed the 2-week treatment phase and follow-up period of study CTP2S13031H3 (NCT04072380) as planned and wish to continue unblinded treatment with SUVN-G3031 (2 mg, qd). 2. Subject must sign the ICF to participate in the study. 3. The investigator after review of relevant information and in consultation with the subject believes that continued treatment following study CTP2S13031H3 could be beneficial to the subject.

Exclusion criteria

1. Any clinically relevant concomitant disease or AEs/SAEs during the Phase 2 study (CTP2S13031H3), which in the opinion of the investigator, makes the subject unsuitable for inclusion in the protocol. 2. Has participated or is participating in any other clinical (investigational) study after completion of CTP2S13031H3 protocol (NCT04072380).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026