January 17, 2025
Welcome to the first issue of the MAGNITUDE-2 newsletter, containing important study-related information, updates, and data. Please file it in your Investigator Site File (ISF) binder because it is a study correspondence. If you have any comments or suggestions, contact your CRA, your Medpace regulatory submissions coordinator, or the study team.
Intellia and the Mayo Clinic Peripheral Nerve Research Lab will be hosting in-person mNIS+7 training for site QST, NCS, and CNA assessors in Minneapolis (USA) on the following dates:
• 17-Jan-2025 to 18-Jan-2025
• 31-Jan-2025 to 01-Feb-2025
• 25-Apr-2025 to 26-Apr-2025
Members from our partner SCOUT are supporting training organization and travel logistics. Invitations are being sent to your site’s assessors for the most appropriate training session based on planned activation dates and their availability. Please reach out to Annika Hermanson (Annika.hermanson@scoutclinical.com) if you have any questions.
Regional Investigator Meetings (IMs) are planned for the following dates. Attendees will be contacted by Medpace team members to arrange transportation and logistics to the appropriate event.
• APAC IM (Singapore) – 28-Feb-2025 to 01-Mar-2025
• LATAM IM (Buenos Aires, Argentina) – 09-May-2025 to 10-May-2025
• Congratulations to Dr. Gane and the New Zealand Clinical Research team for being the first site activated on 12-Nov-2024!
• Congratulations to Dr. Silsby and the Westmead Hospital team for becoming active on 13-Jan-2025!
Congratulations to Dr. Gane and the New Zealand Clinical Research team for consenting the first study participant on 22-Nov-2024!
The CASE IV device will be shipped to your site prior to your SIV. Some of the testing materials are contained within the CASE IV’s water reservoir during shipping to conserve space. Please find the CASE IV Assembly video and WR Medical Support Desk information below for assistance. If you have questions regarding CASE IV assembly, contact your CRA.
• CASE IV Assembly Video
• CASE IV Assembly Video
• Password: NTLAmNIS+7!!
• WR Medical Support Desk
• Email: helpdesk@wrmed.com
• Phone: +1 651 604 8400
• Four normal control mNIS+7 assessments are required to be approved by the Mayo Clinic Peripheral Nerve Research Lab (MC PNRL) prior to site activation. These are detailed below. Your site will be responsible for identifying and consenting two healthy volunteers to undergo the normal control assessments.
• Each assessor must wait to perform the next numbered assessment until all components have been approved by the Mayo Clinic.
• Assessment #1
• Health Volunteer Under 50 Years Old (CNA, QST, NCS, PHT)
• Assessment #2
• Healthy Volunteer Under 50 Years Old (CNA, QST, NCS, PHT)
• Assessment #3
• Healthy Volunteer Over 50 Years Old (CNA, QST, NCS, PHT)
• Assessment #4
• Healthy Volunteer Over 50 Years Old (CNA, QST, NCS, PHT)
• Each assessment’s components should be provided as separate PDF files to MC PNRL at RSTPNCGU8@mayo.edu, with a copy to your CRA and the MAGNITUDE2@medpace.com mailbox.
• Once all normal controls have been performed and approved, the MC PNRL team will provide an approval letter, with a unique assessor/examiner code, to be used when performing study assessments.
• Start planning your Normal Controls early so your site activation is not delayed.Medidata (EDC)
• In order to fulfill an activation requirement, the Principal Investigator and a study coordinator must have EDC access. CRAs will request EDC access for site personnel.
• After CRAs request access, an email will be sent notifying the site team member that they have been granted access.
• The site team member will need to log into Medidata and complete assigned trainings.
• Suvoda IRT is being used for the MAGNITUDE-2 study. Prior to being activated, the Principal Investigator and study coordinator must have access to Suvoda IRT. An unblinded site pharmacist will require access prior to first participant randomization.
• To request Suvoda IRT access for this study, see the instructions below. Please do not request access until 2 weeks prior to your SIV to avoid accounts timing out.
1. Navigate to prod.suvoda.com/suvoda.
2. In the center of the welcome screen, click “Request Study Access”.
3. Enter the following study code: Intellia-ITL-2001-CL-311 and click “Submit”.
4. If you have a Suvoda account for another study, you can select to “Use Existing Account”.
5. To create a new account, select “Create New Account”. You will be prompted to create a username and password. Ensure that your email address is entered correctly, as this is where all Suvodagenerated notifications will be sent.
6. Check the box indicating that you have read and agree to the user statement and select “Submit”.
• Please note that the drug shipment recipient at your site must be unblinded.
Please reach out to your Medpace CRA for any questions you might have. We will be able to help!
• The Study Reference Manual is available in the Study Reference Manual Binder provided in the Welcome Pack. It is a thorough guide of Key Study Contacts, Study Systems, Activation Criteria, Participant Recruitment and Retention, Study Assessments and Safety, and a useful document to reference throughout the study.
• A reminder that the Case IV and Testworks Troubleshooting Guide is provided in the welcome pack. The Troubleshooting Guide should be the first document referenced by CASE IV users when encountering QST-related issues.
• In general, technical issues should be directed to WR Medical (e.g., a cracked thermal stimulator needs replacement). Tasks that are more administrative in nature should be directed to and performed by your CRA (e.g., creating a new user account). Other issues can be corrected by the QST assessor themselves. Particularly because of differing time zones, assessors should make every attempt to resolve the issues that fall into this category prior to reaching out to WR Medical for further assistance.
• It is always recommended that a Hot Spot test be conducted two weeks before a subject is present, so that the system can be checked with adequate time for repairs, if necessary. This may help reduce any unnecessary out of window protocol deviations. Running a Hot Spot test will check all aspects of the function of the CASE IV system
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