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Topic: update winston laboratories (Read 333 times) |
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cbolony
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update winston laboratories
« on: Jan 14th, 2003, 5:53pm » |
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Intranasal Civamide for the Treatment of Episodic Cluster Headaches
Joel R. Saper, MD; Jack Klapper, MD; Ninan T. Mathew, MD; Alan Rapoport, MD; Scott B. Phillips, MD; Joel E. Bernstein, MD; for the Intranasal Civamide Study Group
Objective To evaluate the safety and efficacy of intranasal civamide solution for preventive treatment during an episodic cluster headache period.
Subjects and Methods This was a multicenter, double-blind, randomized, vehicle-controlled study with a 7-day treatment period and a 20-day posttreatment period performed at 14 headache/neurology centers in the United States. Twenty-eight subjects were randomized to receive civamide or its vehicle in a 2:1 ratio; 18 received civamide and 10 received the vehicle. Subjects received 100 µL of 0.025% civamide (25 µg) or 100 µL of the vehicle to each nostril via dropper once daily for 7 days. The total daily dose of civamide was 50 µg.
Main Outcome Measures The number of cluster headaches per week during the treatment and posttreatment periods, pain intensity, presence of associated symptoms, and the incidence of adverse events were assessed.
Results Subjects in the civamide group had a significantly greater percent decrease in the number of headaches from baseline to posttreatment during days 1 through 7 (-55.5% vs -25.9%; P = .03) and a trend toward significance during days 8 through 14 (-66.9% vs -32.3%; P = .07) and days 15 through 20 (-70.6% vs -34.9%; P = .07), as well as a near-significant decrease during the entire posttreatment period (days 1 through 20 [P = .054]) compared with the vehicle group. There were larger decreases in the number of headaches per week during the posttreatment period in the civamide-treated group, with trends toward significance during posttreatment days 8 through 14 (-8.6 vs -3.6; P = .09) and days 15 through 20 (-8.9 vs -3.6; P = .07). There were no significant differences between groups in cluster headache pain intensity, number of severe headaches, or associated symptoms. The most common adverse events included nasal burning (14 of 18 civamide-treated subjects, 1 of 10 vehicle-treated subjects; P = .001) and lacrimation (9 of 18 civamide-treated subjects, 0 of 10 vehicle-treated subjects; P = .01).
Conclusion Intranasal civamide solution at a dose of 50 µg may be modestly effective in the preventive treatment of episodic cluster headache.
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