OBJECTIVES: The primary objective was to evaluate the effects of @entity4481 relative to placebo in @entity1 with chronic unilateral @entity12417 . Primary and secondary end points: To assess the change from baseline in the frequency of @entity12417 days per 28-day period between placebo and treatment group. To assess the change from baseline in the intensity of @entity10 , and health outcome measures. STUDY DESIGN: This was a double-blind, randomized, placebo-controlled, parallel-group study, evaluating the efficacy and safety of @entity4481 in @entity1 with @entity12417 . PROCEDURES: The study consisted of two phases. A baseline of -28 days and a double-blind placebo-controlled phase: with an escalation and maintenance phase, during which @entity1 remained at their highest dose until the end of the study, at Day 86. RESULTS: Forty one @entity1 were randomized, predominantly females, with a mean age of 52 years old. At screening, both groups had, on average, 26 @entity10 -days per month. By the final phase of the study, the number of @entity10 days dropped to 16 per month for the @entity4481 group while remaining stable for the placebo group (p=0.037). No serious adverse events were reported during the study. CONCLUSION: In this study, primary objectives were achieved with a statistically significant change of ten days in frequency of @entity10 days; with minor side effects that were well tolerated.

XXXX for the management of @entity12417 : a double blind study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity4481 :: ('MESH:C080245', 'Chemical') :: ['pregabalin'] @entity12417 :: ('MESH:D051298', 'Disease') :: ['cervicogenic headache']
@entity4481 :: (MESH:C080245,Chemical) :: ['Pregabalin']
