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Cypress Bioscience – Increased Separation from Placebo
Therapeutic Category: Pain (Fibromyalgia)
Result: Superior separation from placebo
Value to Cypress: Sensitive test of endpoint, free from recall bias that can enhance the placebo response
Description: invivodata's ePRO system enabled a sensitive test of real-time pain experiences that delivered better data for Cypress Bioscience, Inc. Cypress used invivodata's ePRO system in the Phase II study of Milnacipran, its potential treatment for Fibromyalgia Syndrome (FMS). This decision was based on the strong results that Cypress obtained using invivodata's eDiary system in an earlier trial in fibromyalgia patients. invivodata's protocol design consulting combined with the functionality of invivodata's eDiaries delivered a more sensitive test of the drug's effect, free of recall bias that can obscure separation from placebo. Moreover, the FDA approved the use of invivodata's ePRO system to collect primary endpoint data in the on-going Phase III pivotal trial.
Patients with FMS typically experience chronic pain throughout their body, which is often associated with fatigue and difficulty sleeping. Patients used invivodata's DiaryPRO to record their pain levels in real-time. As a result, invivodata's ePRO system reflected the patient's improving pain scores much more accurately than recall-based measures of their pain.
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