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Safety and Efficacy of Activation
AUTHOR(S): J. Smith1, M. leuven2, and T. Wells1
DEPARTMENT: Clinical Affairs/Medical Affairs1, Statistics & Data Management/Medical Affairs2
TITLE: Final Study Report – Protocol 77344.AA A Double-Blind, Randomized, Parallel, Multicenter Dose Ranging Study to Compare the Safety and Efficacy of Two Dosages of Activation in the Treatment of Writer's Block.
PREPARED BY: Michael Ryan, PhD, Medical Marketing Decisions
Abstract
This was a double-blind, randomized, parallel, multicenter dose ranging study to compare the safety and efficacy of Activation 2 mg and 4 mg in the treatment of writer's block. A total of 156 subjects were enrolled: (2 mg, 78; 4 mg, 78). There were 145 (93.0%) subjects (2 mg, 73; 4 mg, 72) who completed the study. All subjects were evaluable for efficacy.
2 mg and 4 mg treatments were demonstrated to be effective in the reduction of total block, and partial block. The differences between groups in the changes from baseline to Weeks 2, 4, 8 and 12 in block counts were not statistically significant, with the exception of statistically significantly greater reductions in Week 2 partial blocks for 4 mg (14.8%) compared to 2 mg (6.0%) (P = 0.047).
The investigator’s global evaluation of clinical response at the end of the treatment period used a 5-point scale (excellent, good, fair, no change, worse). The difference between treatment groups was not statistically significant (P = 0.892). A good to excellent response was recorded for 53.9% (42/78) of subjects treated with 2 mg and 55.1% (43/78) of subjects treated with 4 mg.
In the subject’s self-assessment (much improved, somewhat improved, not improved, worse, much worse), the difference between treatment groups was not statistically significant (P = 0.475). In both treatment groups, 67 subjects (86%) reported either “Much improved” or “Somewhat improved”.
Both 2 mg and 4 mg does of Activation were well tolerated. The type and frequency of AEs and cutaneous treatment effects were consistent with the established safety profile of similar products in subjects with writer's block. There were no unusual or unexpected AEs.
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