Rao, R.D., Flynn, P.J., Sloan, J.A., Wong, G.Y., Novotny, P., Johnson, D.B., . . . Loprinzi, C.L. (2008). Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: A phase 3 randomized, double blind, placebo-controlled trial, N01C3. Cancer, 112, 2802–2808.
Patients were randomized to either lamotrigine or placebo. Sixty-three patients were randomized to lamotrigine and 62 to placebo. The dose was escalated from 25 mg at bedtime to 150 mg twice daily, a regimen that continued for two weeks. Ten weeks after drug initiation, patients tapered off lamotrigine or placebo over a four-week period.
Phase III randomized, double-blind, placebo-controlled trial
A total of 125 patients enrolled, but only 80 completed the study. Authors observed no significant differences between the two groups in the pain scale or the ENS.
Lamotrigine was not effective in relieving chemotherapy-induced peripheral neuropathy.