NCT00868556 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bigal ME, Tepper SJ, Sheftell FD, Rapoport AM, Lipton RB
Field testing alternative criteria for chronic migraine. Cephalalgia. 2006 Apr;26(4):477-82.
Siberstein SD, Lipton RB, Solomon S, Mathew NT
Classification of daily and near-daily headaches: proposed revisions to the IHS criteria. Headache. 1994 Jan;34(1):1-7. Review.
Silberstein SD, Lipton RB, Sliwinski M
Classification of daily and near-daily headaches: field trial of revised IHS criteria. Neurology. 1996 Oct;47(4):871-5.
Welch KM, Nagesh V, Aurora SK, Gelman N
Periaqueductal gray matter dysfunction in migraine: cause or the burden of illness? Headache. 2001 Jul-Aug;41(7):629-37.
Wolff HG
Headache and Other Head Pain, New York: Oxford Univ Press; 1963

fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?

Clinical trial NCT00868556 - References