Safety, Efficacy and Pharmacokinetics of ALD403



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:January 2013
End Date:February 2014

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A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 1b Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines

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.


Inclusion Criteria

- Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

- History of migraine ≥ 12 months with

- ≥ 5 and ≤ 14 migraine days in each 28 day period in the 3 months prior to
screening

- use of acute migraine medications ≤ 14 days per 28 day period and, within those
days, ≤ 10 days of triptan use per 28 day period in the 3 months prior to
screening and the 28 day period of completion of eDiary prior to randomization

- Women of child-bearing potential and males with partners of child-bearing potential
must agree to use adequate contraception (oral or injectable [depot] estrogen, and/or
progestogen, or selective estrogen receptor modulator contraceptive therapeutic,
intrauterine contraceptive device, or double barrier method [e.g., condom and
diaphragm or spermicidal gel]). Non-childbearing potential is defined as
post-menopausal for at least 1 year or surgical sterilization or hysterectomy at
least 3 months before screening

- Any hormonal therapy (e.g., oral contraceptives, hormone replacement therapy) use is
stable and ongoing for at least 3 months prior to screening and during the 28 day
period from screening to randomization

- Agree not to post any personal medical data related to the trial or information
related to the trial on any website or social media site (e.g., Facebook, Twitter)
until the trial has been completed

Exclusion Criteria

- Confounding pain syndromes including fibromyalgia, chronic musculoskeletal (e.g., low
back pain), psychiatric conditions, dementia, or major neurological disorders other
than migraine that interfere with the participation in the trial

- Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache,
hemicrania continua, new daily persistent headache, basilar, hemiplegic, or familial
hemiplegic migraine

- Regular use (greater than 7 days) of prophylactic headache medication (any preventive
medication or supplement with evidence of efficacy from at least 1 placebo-controlled
trial) within 3 months, or onabotulinumtoxin A within 6 months prior to screening or
during the 28 day period prior to randomization

- Cardiac surgery or cardiac symptoms within 3 months of screening and during the 28
day period prior to randomization

- Suspected or diagnosis of hypertension with or without antihypertensive treatment

- Any ongoing co-morbidity that in the opinion of the Investigator will interfere with
the participation in the trial

- Body Mass Index (BMI) > 39 at screening

- Pregnant, breast-feeding, or planning to become pregnant during the trial

- Patients who have used opioids > 5 days for the treatment of pain in more than 2 of
the 6 months prior to screening or in the 28 day period prior to randomization
We found this trial at
26
sites
Springfield, Missouri 65807
588
mi
from 43215
Springfield, MO
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
92
mi
from 43215
Cincinnati, OH
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
980
mi
from 43215
Hallandale Beach, FL
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
930
mi
from 43215
West Palm Beach, FL
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Anaheim, California 92801
1962
mi
from 43215
Anaheim, CA
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Ann Arbor, Michigan 48104
162
mi
from 43215
Ann Arbor, MI
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Arlington, Texas 76017
927
mi
from 43215
Arlington, TX
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Austin, Texas 78705
1059
mi
from 43215
Austin, TX
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Brooklyn, New York 11235
484
mi
from 43215
Brooklyn, NY
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Chattanooga, Tennessee 37421
360
mi
from 43215
Chattanooga, TN
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Long Beach, California 90806
1975
mi
from 43215
Long Beach, CA
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Miami, Florida 33143
996
mi
from 43215
Miami, FL
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Mt. Pleasant, South Carolina
523
mi
from 43215
Mt. Pleasant, SC
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North Miami, Florida 33161
985
mi
from 43215
North Miami, FL
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Phoenix, Arizona 85027
1657
mi
from 43215
Phoenix, AZ
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Raleigh, North Carolina 27612
374
mi
from 43215
Raleigh, NC
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Rochester, New York 14609
356
mi
from 43215
Rochester, NY
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Roslindale, Massachusetts 02131
639
mi
from 43215
Roslindale, MA
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Salt Lake City, Utah 84106
1512
mi
from 43215
Salt Lake City, UT
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San Diego, California 92108
1948
mi
from 43215
San Diego, CA
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San Francisco, California 94109
2107
mi
from 43215
San Francisco, CA
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Santa Monica, California 90404
1984
mi
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Santa Monica, CA
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2006
mi
from 43215
Seattle, WA
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Virginia Beach, Virginia 23454
435
mi
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Virginia Beach, VA
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Walnut creek, California 94598
2083
mi
from 43215
Walnut creek, CA
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Watertown, Massachusetts 02472
636
mi
from 43215
Watertown, MA
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