Achieve 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.
Online PR News – 16-October-2013 – Birmingham, Alabama – *To see if you qualify for this Migraine Clinical Trial in Alabama, visit Achieve Clinical Research on the web (http://www.achieveclinical.com/) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
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 is 2 tablets.
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.
The objective of this study is to compare the efficacy of a single dose of acetaminophen (consisting of 2 tablets) with a single dose of placebo in the acute treatment of migraine.
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.
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. For more information about participating in a Migraine Clinical Study, please visit our website or contact us directly at (205) 380-6434.