IntraBio Inc. Pivotal Trial Announcement: IB1001-301, “Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C (NPC): A Phase III, randomized, placebo-controlled, double-blind, crossover study.”
We are pleased to share the news that recruitment to IntraBio’s Pivotal Trial of IB1001-301 will open in the UK in July 2022.
The trial, IB1001-301 “Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C (NPC): A Phase III, randomized, placebo-controlled, double-blind, crossover study” will be conducted at 16 multinational sites in Australia, Europe, the United Kingdom, and United States.
In the UK, there will be 4 trial sites:
With a high level of interest, it is expected that recruitment will be completed by December 2022. Patients and families who are interested in learning more about the trial, including the eligibility criteria and enrolment process, are encouraged to contact their specialist consultant, or one of the trial sites listed above. Alternatively, you can contact Laura Bell, NPUK Clinical Nurse Specialist by email: firstname.lastname@example.org or visit www.clinicaltrails.gov and search using the identifier NCT05163288.
You can find a brief summary of the eligibility criteria, trial design, and trial sites provided in the attached document here.