TY - JOUR
T1 - Preemptive oral treatment with sumatriptan during a cluster period
AU - Monstad, I.
AU - Krabbe, A.
AU - Micieli, G.
AU - Prusinski, A.
AU - Cole, J.
AU - Pilgrim, A.
AU - Shevlin, P.
PY - 1995
Y1 - 1995
N2 - This multinational, multicenter, randomized, double-blind, placebo- controlled study in 169 patients investigated the effect of a 7-day period of preemptive treatment with oral sumatriptan (100 mg tid) on the frequency and severity of cluster headache attacks occurring during an established cluster headache period. Safety and tolerability were also assessed. Cluster headache patients who were not taking prophylactic medication and had experienced seven or more attacks in the preceding observation week, treated a cluster headache attack at home with subcutaneous sumatriptan 6 mg using an autoinjector device. Patients were then randomized to take sumatriptan 100 mg or placebo at 8-hourly intervals for a 7-day period. Cluster headaches occurring during this period could be treated 5 minutes after onset with rescue medication (100% oxygen or simple analgesics). Diary cards were used to record details of the cluster headache pattern during the observation and study treatment weeks. Preemptive oral treatment with sumatriptan 100 mg tid for 7 days did not produce a significant reduction in the number or severity of cluster headache attacks occurring during an established cluster headache period. Oral treatment with sumatriptan 100 mg tid over a 7-day period was not associated with an increased or altered adverse event profile from that previously reported.
AB - This multinational, multicenter, randomized, double-blind, placebo- controlled study in 169 patients investigated the effect of a 7-day period of preemptive treatment with oral sumatriptan (100 mg tid) on the frequency and severity of cluster headache attacks occurring during an established cluster headache period. Safety and tolerability were also assessed. Cluster headache patients who were not taking prophylactic medication and had experienced seven or more attacks in the preceding observation week, treated a cluster headache attack at home with subcutaneous sumatriptan 6 mg using an autoinjector device. Patients were then randomized to take sumatriptan 100 mg or placebo at 8-hourly intervals for a 7-day period. Cluster headaches occurring during this period could be treated 5 minutes after onset with rescue medication (100% oxygen or simple analgesics). Diary cards were used to record details of the cluster headache pattern during the observation and study treatment weeks. Preemptive oral treatment with sumatriptan 100 mg tid for 7 days did not produce a significant reduction in the number or severity of cluster headache attacks occurring during an established cluster headache period. Oral treatment with sumatriptan 100 mg tid over a 7-day period was not associated with an increased or altered adverse event profile from that previously reported.
KW - cluster headache
KW - efficacy
KW - placebo- controlled
KW - preemptive treatment
KW - safety
KW - sumatriptan
UR - http://www.scopus.com/inward/record.url?scp=0029587439&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0029587439&partnerID=8YFLogxK
U2 - 10.1111/j.1526-4610.1995.hed3510607.x
DO - 10.1111/j.1526-4610.1995.hed3510607.x
M3 - Article
C2 - 8550362
AN - SCOPUS:0029587439
VL - 35
SP - 607
EP - 613
JO - Headache
JF - Headache
SN - 0017-8748
IS - 10
ER -