Abstract | OBJECTIVES: 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.
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Authors | Sangeeta Sharma, Atul Prasad, Ravi Nehru, K S Anand, R K Rishi, Sujata Chaturvedi, J S Bapna, Deepika Rohtagi Sharma |
Journal | Headache
(Headache)
Vol. 42
Issue 9
Pg. 896-902
(Oct 2002)
ISSN: 0017-8748 [Print] United States |
PMID | 12390617
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Dopamine Antagonists
- Drug Combinations
- Caffeine
- Ergotamine
- Prochlorperazine
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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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