PURVIEW

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Open-Label safety study to evaluate the Long-Term Safety and Tolerability of Sage-718 in Participants with Huntington’s Disease

• IRAS ID

  1007162

• Contact name

  Robert Solinga

• Contact email

  robert.solinga@sagerx.com

• Sponsor organisation

  Sage Therapeutics, Inc.

• Eudract number

  2022-003623-18

• Clinicaltrials.gov Identifier

  NCT05655520

• Research summary

  This is a long-term, open-label study to evaluate the long-term safety and tolerability of SAGE-718 in participants with premanifest or early manifest Huntington Disease.
  For patients who completed a previous SAGE-718 HD Study (protocol number 718-CIH-201/DIMENSION) within the past 7 days of consent, this study will last for approximately 12 months or 365 days of Treatment Period.
  For patients who completed a previous SAGE-718 HD study more than 7 days prior to consent OR have not participated in a previous Sage-718 HD study, this study will last for approximately 13 months or 393 days, including Screening and Treatment period.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  23/LO/0257

• Date of REC Opinion

  26 Sep 2023

• REC opinion

  Further Information Favourable Opinion