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Nalpha-methyl histamine safety and efficacy in migraine prophylaxis: phase III study.

AbstractBACKGROUND:
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.
AuthorsRebeca O Millán-Guerrero, Rebeca Isais-Millán, Trujillo-Hernández Benjamín, Carlos E Tene
JournalThe 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] Canada
PMID16736729 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
Chemical References
  • Analgesics
  • Histamine Agonists
  • Methylhistamines
  • Placebos
  • Receptors, Histamine H3
  • Histamine
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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