The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
163
Premiere Research
Safety of ALD403: laboratory variables, ECG and adverse events
* Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events
Time frame: 24 weeks
Evaluation of Pharmacokinetics of ALD403
* Cmax - maximum plasma concentration * Tmax - Time to achieve maximum plasma concentration * AUC - Area under the plasma concentration-time curve * T1/2 - Elimination half-life * Vz - Volume of distribution * CL - Clearance * Bioavailability * Plasma levels of unbound ALD403
Time frame: 24 weeks
Efficacy of ALD403
* Change in frequency of migraine days compared to baseline * Responder rate * Migraine hours * Migraine episodes * Migraine severity * Use of acute migraine medications
Time frame: 12 weeks
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Phoenix, Arizona, United States
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Collaborative Neuroscience Network, Inc.
Long Beach, California, United States
Medical Center for Clinical Research
San Diego, California, United States
San Francisco Clinical Research
San Francisco, California, United States
CA Medical Clinic for Headache
Santa Monica, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
MD Clinical
Hallandale, Florida, United States
Miami Research
Miami, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
...and 16 more locations