Aclarion revises CLARITY screening rules as enrollment lags
Aclarion revised eligibility rules for its pivotal CLARITY trial after the original criteria limited the available patient pool and enrollment fell short of the pace needed for a Q4 2026 initial readout. Institutional Review Boards have approved the new rules at 9 of 11 active sites, while the remaining sites are screening patients under the revisions pending local approval. The company will update enrollment and the projected timing of the first readout by year-end 2026.
Why it matters
The revised rules could expand CLARITY's recruitable population and reduce a key operational constraint for Aclarion's Nociscan validation study. Aclarion says the trial's full planned duration remains within its original schedule, despite the later update on the initial readout.
Key facts
- 1Aclarion said the prior enrollment rules did not support an initial readout in Q4 2026. globenewswire.com
- 2The revised criteria received full IRB approval at 9 of 11 active CLARITY sites. globenewswire.com
- 3The other 2 active sites are using the revised criteria for screening while awaiting local IRB approval. globenewswire.com
- 4Aclarion plans to provide an enrollment and initial-readout timing update by year-end 2026. rttnews.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.