An extension study to learn if bepranemab is safe over a long period in adults with progressive supranuclear palsy
- Conditions
- Progressive Supranuclear PalsyMedDRA version: 21.1Level: PTClassification code: 10036813Term: Progressive supranuclear palsy Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-510951-36-00
- Lead Sponsor
- CB Biopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 19
Participant meets the criteria for possible or probable progressive supranuclear palsy (PSP) Richardson's Syndrome according to the Movement Disorder Society-PSP criteria (Höglinger et al, 2017) - Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003 - Participant can be male or female a) A male participant must agree to use contraception as detailed in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period b) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: I. Not a woman of childbearing potential (WOCBP) OR II. A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment. - Participant (or legal representative, as applicable and acceptable by local regulations) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent must be obtained before initiating any study procedures
- Participant has met a mandatory withdrawal and/or stopping criterion in PSP003 - Participant made a suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) during PSP003, or has current suicidal ideation with at least some intent to act as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Since Last Visit version of the Columbia Suicide Severity Rating Scale (C-SSRS) at the Day 1 Visit. However, participants will not be excluded if, based upon a mental healthcare professional assessment, and the investigator's judgment of benefit/risk, the participant is deemed suitable for receiving study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method