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

Primary Purpose

Narcolepsy

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Samelisant
Sponsored by
Suven Life Sciences Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Narcolepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

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).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 2, 2022
    Last Updated
    September 21, 2022
    Sponsor
    Suven Life Sciences Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05530447
    Brief Title
    Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy
    Official Title
    An Intermediate-size, Expanded Access to SUVN-G3031 for the Treatment of Subjects With Narcolepsy Who Have Completed the CTP2S13031H3 Protocol
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Suven Life Sciences Limited

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Narcolepsy

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Samelisant
    Other Intervention Name(s)
    SUVN-G3031
    Intervention Description
    Tablet

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Eligibility Criteria
    Inclusion Criteria: 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). Subject must sign the ICF to participate in the study. 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: 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. Has participated or is participating in any other clinical (investigational) study after completion of CTP2S13031H3 protocol (NCT04072380).

    12. IPD Sharing Statement

    Learn more about this trial

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

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