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Clinical Pharmacology
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Clinical Pharmacology

Botox

Placebo N=82

BOTOX® N=88

95% Cl on Difference

Baseline CDSS

9.3

9.2  

Change in CDSS at Week 6

-0.3

-1.3

(-2.3, 0.3)[a,b]

Percentage Patients with Any Improvement on Physicians Global Assessment

31%

51%

(5%, 34%)[a]

Pain Intensity Baseline

1.8

1.8  

Change in Pain Intensity at Week 6

-0.1

-0.4

(-0.7, -0.2)[c]

Pain Frequency Baseline

1.9

1.8  

Change in Pain Frequency at Week 6

-0.0

-0.3

(-0.5, -0.0)[c]

[a] Confidence intervals are constructed from the analysis of covariance table with treatment and investigational site as main effects, and baseline CDSS as a covariate.

[b] These values represent the prospectively planned method for missing data imputation and statistical test. Sensitivity analyses indicated that the 95% confidence interval excluded the value of no difference between groups and the p-value was less than 0.05. These analyses included several alternative missing data imputation methods and non-parametric statistical tests.

[c] Confidence intervals are based on the t-distribution

Exploratory analyses of this study suggested that the majority of patients who had shown a beneficial response by week 6 had returned to their baseline status by 3 months after treatment. Exploratory analyses of subsets by patient sex and age suggest that both sexes receive benefit, although female patients may receive somewhat greater amounts than male patients. There is a consistent treatment-associated effect between subsets greater than and less than age 65 (see also PRECAUTIONS: Geriatrics). There were too few non-Caucasian patients enrolled to draw any conclusions regarding relative efficacy in racial subsets.

There were several randomized studies conducted prior to the phase 3 study which were supportive but not adequately designed to assess or quantitatively estimate the efficacy of BOTOX®.

In the phase 3 study the median total BOTOX® dose in patients randomized to receive BOTOX® (n=88) was 236 Units, with 25th to 75th percentile ranges of 198 to 300 Units. Of these 88 patients, most received injections to 3 or 4 muscles; 38 received injections to 3 muscles, 28 to 4 muscles, 5 to 5 muscles and 5 to 2 muscles. The dose was divided amongst the affected muscles in quantities shown in Table 2. The total dose and muscles selected were tailored to meet individual patient needs.

Table 2: Number of Patients Treated Per Muscle And Fraction Of Total Dose Injected Into Involved Muscles

Muscle*

Number of Patients Treated in this Muscle (N=88)

Mean % Dose per Muscle

Mid-Range of % Dose per Muscle*

Brand Name: Botox
Generic Name: Botulinum Toxin Type A
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