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        New Message Board Archives >> 2002 Posts >> First FDA-approved treatment of CHs
        
(Message started by: Ted on Sep 1^st, 2002, 9:03pm)

Title: First FDA-approved treatment of CHs
Post by Ted on Sep 1^st, 2002, 9:03pm

Here's who we should really thank. Many of us already know of the capsacian treatment but they actually did research to get the first approved treatment for us. They knocked down a wall and now maybe we'll start getting a number of medications specifically for us.

Medscape Medical News
Intranasal Civamide Helps Prevent Episodic Cluster Headache

Laurie Barclay, MD

July 9, 2002 — Intranasal civamide, a synthetic isomer of capsaicin, may be modestly effective in preventing episodic cluster headache, according to results of a multicenter, double-blind, randomized trial reported in the June issue of the Archives of Neurology.
"When civamide is applied intranasally to the mucosa, the release of neurotransmitters by the trigeminal plexus centrally to meningeal and dural blood vessels should be decreased," write Joel R. Saper, MD, from the Michigan Headache Pain and Neurological Institute in Ann Arbor, and colleagues. "This would then result in less vasodilation, plasma extravasation, and histamine/serotonin release, with a potential for the amelioration of neurogenic inflammation and cluster headache pain."

This study evaluated 28 subjects at 14 headache/neurology centers in the United States. Over a seven-day treatment period, 18 subjects received 100 ÌL of 0.025% civamide (25 Ìg ; total daily dose, 50 Ìg ) and 10 received 100 ÌL of the vehicle to each nostril via dropper once daily. Observation continued over a 20-day posttreatment period.

Decrease in the number of headaches from baseline to posttreatment during days 1 through 7 was -55.5% in the civamide group and -25.9% in control patients (P=.03). There was a trend suggesting continued decrease in the number of headaches with civamide during the 20-day follow-up period (P=.05).

Both groups were similar in cluster headache pain intensity, number of severe headaches, and associated symptoms. The most common adverse events included nasal burning in 14 of 18 civamide-treated subjects and in 1 of 10 vehicle-treated subjects (P=.001) and lacrimation, seen in nine of 18 civamide-treated subjects and in none of the controls (P=.01).

"Intranasal civamide solution at a dose of 50 Ìg may be modestly effective in the preventive treatment of episodic cluster headache," the authors write. "There are no medications for the prevention of cluster headaches currently approved by the Food and Drug Administration, and subcutaneous sumatriptan is the only approved medication for abortive therapy of individual cluster headache attacks. Since cluster headaches are among the most severe headaches known and result in significant disability during active cluster periods, any therapy that can reduce their frequency would be valuable."

The authors suggest that the small number of subjects may have contributed to the lack of significance of the secondary efficacy parameters. To decrease the transient nasal burning, rhinorrhea, and lacrimation, they propose several modifications in civamide administration. Future studies will be larger, prospective rather than retrospective, and will have a longer posttreatment period.

"This study offers early support for the possible value of intranasal civamide as a safe and effective preventive treatment for episodic cluster headache," they conclude.

Winston Laboratories Inc., Vernon Hills, Illinois, partially funded this study.

Arch Neurol. 2002;59:990-994

Reviewed by Gary D. Vogin, MD

Title: Re: First FDA-approved treatment of CHs
Post by paul_b on Sep 1^st, 2002, 9:44pm

Interesting post. Thank you. Anything on the horizon that helps is positive news.

Title: Re: First FDA-approved treatment of CHs
Post by SFChris on Sep 2^nd, 2002, 12:31pm

This drug is the one being tested (see DJ's top post about the Clinical trial). I am part of this trial, but have yet to receive the drug. I'll post results when I actually get the drug (or placebo!).

Title: Re: First FDA-approved treatment of CHs
Post by oringkid on Sep 3^rd, 2002, 8:43am

And you guys thought I was crazy for putting tabasco up my nose.

Tabasco has capsaicin in it. Told you it works sometimes!
;D ;D ;D ;D ;D ;D ;D

Sherry

Title: Re: First FDA-approved treatment of CHs
Post by Drk^Angel on Sep 3^rd, 2002, 12:33pm

Yeah... What the kid said... But instead of Tobasco, I'd recommend habenero sauce. It gives you that extra kick that you need.

PFDAN...................... Drk^Angel

Title: Re: First FDA-approved treatment of CHs
Post by eyes_afire on Sep 3^rd, 2002, 3:55pm

Oringkid, I didn't think you were crazy. I tried it myself. ::) :D :D Desperation will do that. It wasn't as uncomfortable as you would think. Didn't help though. Ah well, at least Cholula sauce makes good hot fries ::).