Abstract | BACKGROUND: The histamine catabolite, Nalpha-methylhistamine, possesses a selective affinity for H3 receptors. For this reason, we considered evaluating the efficacy of this histaminergic H3 agonist in migraine prophylactic treatment. OBJECTIVE: To study the therapeutic potential of the subcutaneous administration of Nalpha-methylhistamine in migraine prophylaxis, in a Phase III clinical pharmacological study. METHODS: Using a controlled double-blind, placebo controlled clinical trial for 12 weeks, 60 patients with migraine, who fit the criteria established by the International Headache Society, were selected. The efficacy of subcutaneous administration of Nalpha-methylhistamine 1 to 3 ng twice a week against placebo was studied, evaluating the outcome of headache intensity, frequency, duration, and analgesic intake. RESULTS: Comparison between the groups treated with placebo ( n=30) and Nalpha-methylhistamine ( n=30), on data collected for the 4th, 8th and 12th weeks of treatment, revealed that Nalpha-methylhistamine exerted a significant (p<0.0001) reduction (compared to placebo) in intensity, frequency, and duration of migraine attacks, as well as on the use of analgesic intake. No significant (p>0.05) adverse experiences or side effects developed in either group. CONCLUSIONS: The present study provides evidence of the efficacy of Nalpha-methylhistamine, given subcutaneously at doses of 1 to 3 ng twice a week, offering a new therapeutic alternative and laying the clinical and pharmacological groundwork for the use of histaminergic H3-agonists in migraine prophylaxis, which may specifically inhibit the neurogenic edema response involved in migraine pathophysiology.
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Authors | Rebeca O Millán-Guerrero, Rebeca Isais-Millán, Trujillo-Hernández Benjamín, Carlos E Tene |
Journal | The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques
(Can J Neurol Sci)
Vol. 33
Issue 2
Pg. 195-9
(May 2006)
ISSN: 0317-1671 [Print] England |
PMID | 16736729
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Analgesics
- Histamine Agonists
- Methylhistamines
- Placebos
- Receptors, Histamine H3
- Histamine
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Topics |
- Adult
- Analgesics
(administration & dosage)
- Cerebral Arteries
(drug effects, metabolism, physiopathology)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Histamine
(metabolism)
- Histamine Agonists
(administration & dosage, adverse effects)
- Humans
- Injections, Subcutaneous
- Male
- Methylhistamines
(administration & dosage, adverse effects)
- Middle Aged
- Migraine Disorders
(drug therapy, physiopathology, prevention & control)
- Placebos
- Receptors, Histamine H3
(drug effects, metabolism)
- Treatment Outcome
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