Summary
Two double-blind, randomized, placebo-controlled multicentre studies were carried out to assess the efficacy and tolerability of subcutaneous (s. c.) injections of 1-3 mg and 1-8 mg sumatriptan, respectively, in the acute treatment of migraine. Data are presented from a total of 519 patients. In both studies, the primary endpoint of efficacy was a reduction in headache severity from severe or moderate to mild or no headache. All doses of sumatriptan were significantly more effective than placebo in relieving symptoms, and the response appeared to be dose-related; an effective response to treatment was achieved within 30 min in 73% of patients treated with 6 mg sumatriptan and 80% of patients treated with 8 mg sumatriptan s. c., compared with 22% for placebo. Sumatriptan was well tolerated and the majority of adverse events were mild and transient. The most frequent complaint was irritation and pain at the site of injection. No changes in laboratory values were noted and ECG readings were unaltered by treatment. On the basis of these results, the 6 mg subcutaneous dose has been selected for further evaluation in large-scale studies.
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Baar HA, Brand J, Doenicke A, Melchart D, Lüben V, Tryba M, Sahlender HM (1989) Treatment of acute migraine with subcutaneous GR43175 in West Germany. Cephalalgia 9 (suppl 9):83–87
Brion N, Bons J, Plas J, Bayliss EM, Advenier C (1989) Initial clinical experience with the use of subcutaneous GR43175 in treating acute migraine. Cephalalgia 9 (suppl 9):79–82
Doenicke A, Brand J, Perrin VL (1988) Possible benefit of GR43175, a novel 5-HT1-like receptor agonist, for the treatment of severe migraine. Lancet I:1309–1311
Fowler PA, Thomas M, Lacey LF, Andrew P, Dallas FAA (1989) Early studies with the novel 5-HT1-like agonist GR43175 in healthy volunteers. Cephalalgia 9 (suppl 9):57–62
Headache Classification Committee of the International Headache Society (1988) Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 8 (suppl 7):19–28
Olesen J, Tfelt-Hansen P (1988) Methodology of clinical trials in migraine. In: Capildeo R, Orgogozo J-M (eds) Methodology in clinical trials in neurology. Macmillan, London, pp 85–109
Perrin VL, Färkkilä M, Goasguen J, Doenicke A, Brand J, Tfelt-Hansen P (1989) Overview of initial clinical studies with intravenous and oral GR43175 in acute migraine. Cephalalgia 9 (suppl 9):63–72.
Tfelt-Hansen P, Brand J, Dano P, Doenicke A, Findley LJ, Iversen HK, Melchart D, Sahlender HM (1989) Early clinical experience with subcutaneous GR43175 in acute migraine: an overview. Cephalalgia 9 (suppl 9):73–77
Walton J (1985) Brain's diseases of the nervous system, 9th edn. Oxford Medical Publications, Oxford, pp 177–181
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Ensink, F.B.M., the Sumatriptan International Study Group. Subcutaneous sumatriptan in the acute treatment of migraine. J Neurol 238 (Suppl 1), S66–S69 (1991). https://doi.org/10.1007/BF01642910
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DOI: https://doi.org/10.1007/BF01642910