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XenoPort corrects number of patients in drug trial who withdrew over “adverse effects”

On Wednesday, XenoPort, the Santa Clara biopharmaceutical company working with the British drug maker GlaxoSmithKline on an experimental drug to treat restless leg syndrome, corrected its SEC filing of the day before to nearly double the percentage of patients in a clinical trial of the drug who withdrew from it because of “adverse events.”

Oops.

On Tuesday, the companies said that 7 percent of the 327 patients in the single-blind phase of the trial for the drug candidate called XP13512 withdrew from the study complaining of things such as sleepiness and dizziness. In fact, the correct number was 13 percent.

The company also had to raise the percentage of people in the same trial phase who withdrew from the study citing no effect from 2 percent to 4 percent.

Nevertheless, the “top-line” results of the trial remained unchanged, showing that the drug was “generally well-tolerated” and displayed “a statistically significant difference
between the percentage of patients treated with” it and a placebo.

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