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Follow on Google News | Paid Migraine Clinical Trial Now Enrolling at Achieve Clinical Research Near Birmingham, AlabamaAchieve is conducting a randomized, single-dose study comparing the efficacy and safety of a combination of acetaminophen and aspirin vs placebo in the acute treatment of migraine headaches.
By: Achieve Clinical Research STUDY DESIGN This is a Phase 3 randomized, multi-center, single-dose study consisting of three phases and two visits: selection (Visit 1), treatment, and follow-up (Visit 2). BACKGROUND & RATIONALE Excedrin Migraine is well-established as an effective treatment for migraine that combines 250 mg aspirin, 250 mg acetaminophen and 65 mg caffeine per tablet. The unit dose to treat the symptoms of migraine (http://www.achieveclinical.com/ For the benefit of migraineurs who want to limit their intake of caffeine in general or who experience a migraine in the evening when consumption of caffeine may be undesirable, it is of interest to test the efficacy of the product without caffeine. Therefore, this study will compare the efficacy and safety of a combination of aspirin and acetaminophen with placebo in the acute treatment of migraine. PRIMARY OBJECTIVES The objective of this study is to compare the efficacy of a single dose of acetaminophen (http://www.webmd.com/ The primary outcomes are the percent of subjects who are pain free at the 2-hour assessment and the percent of subjects who are nausea free at the 2-hour assessment. Important secondary outcomes are the percentages of subjects who are free of photophobia and phonophobia at the 2-hour assessment. INCLUSION CRITERIA Subjects eligible for inclusion in this study must fulfill all of the following criteria: 1. Male or female aged 18 years and over. 2. IHS diagnosis of migraine without aura or typical aura with migraine headache. 3. History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year. 4. History of at least moderate migraine pain intensity, if left untreated. 5. History of frequently or always experiencing nausea with the migraine attack. 6. Able to distinguish a migraine headache from other headache types (e.g., tension-type headache) at the time of onset of a headache attack. 7. Satisfactory health, as determined by the investigator, based on medical history and physical examination. 8. Willing and able to cooperate with the investigative staff, ingest assigned study drug, complete appropriate evaluation forms, and complete the full course of the study by returning for follow-up visit. 9. Capacity to give informed consent and voluntarily sign and date the informed consent form, approved by an IRB/IEC/REB, prior to the conduct of any study specific procedures. *Achieve Clinical Research conducts Phase II-IV Clinical Trials in Alabama (http://www.achieveclinical.com/ End
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