Randomized trial of cervene, a κ receptor-selective opioid antagonist, in acute ischemic stroke

Wayne Clark, B. M. Coull, M. Karukin, B. Hendin, R. Kelley, H. Rosing, S. Zachariah, M. Winograd, E. Raps, T. Walshe, S. Singer, K. L. Mettinger

Research output: Contribution to journalArticle

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Abstract

The purpose of this randomized trial was to confirm drug safety and to obtain preliminary efficacy data on Cervene (nalmefene), an opioid antagonist with relative κ receptor selectivity, for the treatment of acute ischemic stroke. Patients were treated for 24 hours with either intravenous Cervene (0.05 mg/kg as an initial infusion over 15 minutes and 0.01 mg/kg/h maintenance) or placebo within 6 hours of an ischemic stroke. Efficacy was assessed by comparing the change from baseline to day 7 in the National Institutes of Health stroke scale score (NIHSSS) and the Glasgow Outcome Scale and Barthel Index at 3 months. Forty-four evaluable patients were randomized (3:1) to Cervene (n = 34; treated at 5.0 ± 0.9 hours after onset) and placebo (n = 10; treated at 4.6 ± 1.5 hours). No deaths or serious adverse events reasonably attributable to Cervene have been reported. A "major improvement" (NHSSS > 4) was seen at day 7: placebo, 33% (three of nine patients) and Cervene, 66% (19 of 29 patients). Only patients with initial NIHSSS ≥ 4 were considered evaluable for this primary endpoint. "Good recovery" at 3 months (Glasgow = 5) was as follows: placebo, 50% (5 of 10 patients) and Cervene, 73% (24 of 33 patients). The death rate at 3 months was placebo, 20% (2 of 10 patients) and Cervene, 9.1% (3 of 33 patients). One patient was lost to follow-up. In conclusion, results from this randomized trial suggest that Cervene is safe, tolerable, and may be beneficial in the treatment of acute stroke patients.

Original languageEnglish (US)
Pages (from-to)35-40
Number of pages6
JournalJournal of Stroke and Cerebrovascular Diseases
Volume6
Issue number1
DOIs
StatePublished - Sep 1996

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Narcotic Antagonists
Stroke
Placebos
National Institutes of Health (U.S.)
Glasgow Outcome Scale
Lost to Follow-Up
Maintenance
Safety

Keywords

  • Nalmefene
  • Opiate antagonist
  • Stroke
  • Therapy

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery
  • Rehabilitation
  • Cardiology and Cardiovascular Medicine

Cite this

Randomized trial of cervene, a κ receptor-selective opioid antagonist, in acute ischemic stroke. / Clark, Wayne; Coull, B. M.; Karukin, M.; Hendin, B.; Kelley, R.; Rosing, H.; Zachariah, S.; Winograd, M.; Raps, E.; Walshe, T.; Singer, S.; Mettinger, K. L.

In: Journal of Stroke and Cerebrovascular Diseases, Vol. 6, No. 1, 09.1996, p. 35-40.

Research output: Contribution to journalArticle

Clark, W, Coull, BM, Karukin, M, Hendin, B, Kelley, R, Rosing, H, Zachariah, S, Winograd, M, Raps, E, Walshe, T, Singer, S & Mettinger, KL 1996, 'Randomized trial of cervene, a κ receptor-selective opioid antagonist, in acute ischemic stroke', Journal of Stroke and Cerebrovascular Diseases, vol. 6, no. 1, pp. 35-40. https://doi.org/10.1016/S1052-3057(96)80024-3
Clark, Wayne ; Coull, B. M. ; Karukin, M. ; Hendin, B. ; Kelley, R. ; Rosing, H. ; Zachariah, S. ; Winograd, M. ; Raps, E. ; Walshe, T. ; Singer, S. ; Mettinger, K. L. / Randomized trial of cervene, a κ receptor-selective opioid antagonist, in acute ischemic stroke. In: Journal of Stroke and Cerebrovascular Diseases. 1996 ; Vol. 6, No. 1. pp. 35-40.
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