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Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine.

AbstractOBJECTIVES:
To study the efficacy and tolerability of prochlorperazine (PCZ) management of acute migraine.
DESIGN AND METHODS:
A double blind comparative study was conducted to assess the efficacy of buccal PCZ 3 mg compared with oral ergotamine tartarate 1 mg plus caffeine 100 mg (ERG) or placebo (buccal or oral) for treatment of acute migraine. In all, 114 episodes of acute migraine were evaluated. Patients graded symptoms on a four-point scale before and up to 4 hours after treatment. The primary efficacy parameters included headache resolution within 2 hours (grade 3 or 2 to grade 0) and alleviation of other accompanying symptoms of migraine. The supplementary endpoints included improvement in quality of life (QOL).
RESULTS:
The percentage of patients reporting resolution of headache (to grade 0) was 51.4% for buccal PCZ and 21.7% for buccal placebo, 23.1% for oral ERG and 28.6% for oral placebo, headache tended to recur in both the placebo and ERG groups after initial improvement. Buccal PCZ was well tolerated; no signs of local irritation were evident, and patients found the formulation easy to use. Mild but transient sedation and drowsiness were observed in 41%.
CONCLUSIONS:
In the present study, PCZ 3 mg via the buccal route produced faster improvement and greater efficacy than placebo (oral as well as buccal) or oral ERG. The global QOL score 2 hours after treatment scores was higher in the PCZ group. Buccal PCZ may represent a particularly effective alternative for acute migraine treatment.
AuthorsSangeeta Sharma, Atul Prasad, Ravi Nehru, K S Anand, R K Rishi, Sujata Chaturvedi, J S Bapna, Deepika Rohtagi Sharma
JournalHeadache (Headache) Vol. 42 Issue 9 Pg. 896-902 (Oct 2002) ISSN: 0017-8748 [Print] United States
PMID12390617 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Dopamine Antagonists
  • Drug Combinations
  • Caffeine
  • Ergotamine
  • Prochlorperazine
Topics
  • Acute Disease
  • Administration, Buccal
  • Adolescent
  • Adult
  • Caffeine (administration & dosage)
  • Dopamine Antagonists (administration & dosage, adverse effects)
  • Double-Blind Method
  • Drug Combinations
  • Ergotamine (administration & dosage)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders (drug therapy)
  • Prochlorperazine (administration & dosage, adverse effects)
  • Quality of Life
  • Treatment Outcome

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