Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine.
OBJECTIVE
To study the efficacy and tolerability of prochlorperazine (PCZ) management of acute migraine.


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.
Sharma
Sangeeta
S
Departments of Neuropsychopharmacology, Institute of Human Behaviour & Allied Sciences, Delhi, India.
Prasad
Atul
A
Nehru
Ravi
R
Anand
K S
KS
Rishi
R K
RK
Chaturvedi
Sujata
S
Bapna
J S
JS
Sharma
Deepika Rohtagi
DR
D000208:Acute Disease; D000278:Administration, Buccal; D000293:Adolescent; D000328:Adult; D002110:Caffeine / Q000008:administration & dosage; D018492:Dopamine Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D004878:Ergotamine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D011346:Prochlorperazine / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D016896:Treatment Outcome
D018492:Dopamine Antagonists; D004338:Drug Combinations; D002110:Caffeine; D004878:Ergotamine; D011346:Prochlorperazine