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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
Arch Neurol. 2002;59:990-994.
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.
From the Michigan Headache Pain and Neurological Institute, Ann Arbor
(Dr Saper); Colorado Neurology and Headache Center, Denver (Dr Klapper); Houston
Headache Clinic, Houston, Tex (Dr Mathew); New England Center for Headache,
Stamford, Conn (Dr Rapoport); and Winston Laboratories Inc, Vernon Hills,
Ill (Drs Phillips and Bernstein).
RELATED ARTICLE
Archives of Neurology Reader's Choice: Continuing Medical Education
Arch Neurol. 2002;59(6):1048-1050.
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