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NCT05530447 Clinical Trial

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

Narcolepsy Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT05530447
Other study ID # EAP13031H3
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2022
Source Suven Life Sciences Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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).

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Samelisant
Tablet

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Suven Life Sciences Limited
See also
  Status Clinical Trial Phase
Completed NCT04072380 - A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy Phase 2
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Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
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Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'