Trials / No Longer Available
No Longer AvailableNCT05530447
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
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Suven Life Sciences Limited · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- —
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Samelisant | Tablet |
Timeline
- First posted
- 2022-09-07
- Last updated
- 2022-09-23
Source: ClinicalTrials.gov record NCT05530447. Inclusion in this directory is not an endorsement.