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Abstract Details

CONVEY, A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study Design of Vixotrigine for the Treatment of Pain in Participants With Confirmed Small Fiber Neuropathy
Pain
P2 - Poster Session 2 (5:30 PM-6:30 PM)
7-068
To describe the design of the Phase 2 study of vixotrigine in participants with idiopathic or diabetes-related painful small fiber neuropathy (SFN).
Vixotrigine is a state- and use-dependent Nav1.7 channel blocker under investigation for treatment of multiple neuropathic pain conditions, including SFN. In SFN, damage to small, thinly or unmyelinated peripheral nerve fibers results in severe pain, usually in the feet or hands.

CONVEY is a multicenter, double-blind, enriched enrollment randomized withdrawal study conducted in 6 phases: screening assessment (≤21 days), taper (≤14 days), washout (5 days), open-label (OL) run-in (4 weeks), double-blind (DB, 12 weeks), follow-up (~4 weeks). Key inclusion criteria: ≥18 years old with ≥6-month and ≤10-year history of probable SFN, Average Daily Pain (ADP) Score (11-point Numerical Rating Scale, 0 [no pain]-10 [worst pain]) ≥5 and ≤9 during 7 days before screening and confirmed abnormality in a single skin biopsy. Participants have pain medications tapered (if needed), followed by washout before beginning OL vixotrigine 350 mg twice daily (BID). At the end of the OL run-in, responders (≥30% improvement in mean ADP score over previous 7 days versus baseline, defined as the 5 days prior to the first dose of study treatment in the OL period) continuing to meet enrollment criteria are eligible for randomization (1:1:1; vixotrigine 200 mg: vixotrigine 350 mg: placebo, all BID). Throughout the study, patients track pain symptoms daily in an electronic diary; weekly mean  ADP scores are calculated. Acetaminophen use is permitted during the OL and DB periods, within pre-specified limits. The primary endpoint is the change from baseline to DB Week 12 in the mean ADP score. Safety assessments include adverse events and serious adverse events. 

Global enrollment expected from ~80 sites, with ~186 randomized participants planned.
CONVEY will explore the safety and efficacy of vixotrigine in participants with SFN.
Authors/Disclosures
Leslie Shinobu, MD, PhD
PRESENTER
No disclosure on file
Michael J. Polydefkis, MD, FAAN (Johns Hopkins University School of Medicine) Dr. Polydefkis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam Pharmaceuticals. Dr. Polydefkis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Akcea. Dr. Polydefkis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vertex Pharmaceutical . Dr. Polydefkis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen-Idec. Dr. Polydefkis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer.
Giuseppe Lauria, MD No disclosure on file
No disclosure on file
Roy L. Freeman, MD (Beth Israel Deaconess Hosp) Dr. Freeman has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cutaneous Diagnostic Life Sciences. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vertex. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theravance. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Inhibikase. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Freeman has received research support from NIH. The institution of Dr. Freeman has received research support from Theravance. The institution of Dr. Freeman has received research support from Biohaven. The institution of Dr. Freeman has received research support from Lundbeck. Dr. Freeman has received research support from Regeneron.
Deborah Steiner, MD (Eli Lilly and Company) No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Katherine T. Dawson, MD (Biogen) No disclosure on file