Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia

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Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia

Kotecha, M; Cheshire, WP; Finnigan, H; Giblin, K; Naik, H; Palmer, J; Tate, S; (2020) Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia. Journal of Pain Research , 2020 , Article 13. 10.2147/JPR.S247182. Green open access

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Abstract

Purpose: Vixotrigine (BIIB074) is a voltage- and use-dependent sodium channel blocker. These studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with trigeminal neuralgia (TN) using enriched enrollment randomized withdrawal trial designs. Patients and Methods: Two double-blind randomized withdrawal studies are planned to evaluate the efficacy and safety of vixotrigine compared with placebo in participants with TN (NCT03070132 and NCT03637387). Participant criteria include ≥ 18 years old who have classical, purely paroxysmal TN diagnosed ≥ 3 months prior to study entry, who experience ≥ 3 paroxysms of pain/day. The two studies will include a screening period, 7-day run-in period, a 4- or 6-week single-dose-blind dose-optimization period (Study 1) or 4-week open-label period (Study 2), and 14-week double-blind period. Participants will receive vixotrigine 150 mg orally three times daily in the dose-optimization and open-label periods. The primary endpoint of both studies is the proportion of participants classified as responders at Week 12 of the double-blind period. Secondary endpoints include safety measures, quality of life, and evaluation of vixotrigine population pharmacokinetics. Conclusion: There is a need for an effective, well-tolerated, noninvasive treatment for the neuropathic pain associated with TN. The proposed studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with TN.

Type:	Article
Title:	Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia
Open access status:	An open access version is available from UCL Discovery
DOI:	10.2147/JPR.S247182
Publisher version:	https://doi.org/10.2147/JPR.S247182
Language:	English
Additional information:	This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.
Keywords:	Science & Technology, Life Sciences & Biomedicine, Clinical Neurology, Neurosciences & Neurology, facial pain, neuropathic pain, voltage-gated sodium channels, enriched enrollment randomized withdrawal, EERW, Penn Facial Pain Scale-Revised, PENN-FPS-R, CHRONIC PAIN, DOUBLE-BLIND, EFFICACY, IMPACT, TRIAL
UCL classification:	UCL UCL > Provost and Vice Provost Offices UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Eastman Dental Institute
URI:	https://discovery.ucl.ac.uk/id/eprint/10115549