Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine Headache

In brief

The purpose of this study was to evaluate the effectiveness and safety of a single oral dose of NPS 1776 in the acute treatment of migraine pain and associated symptoms.

Key facts

Study ID

NCT00172094

Run by

Shire

People needed

189

Starts

2003-12-31

Expected to finish

2004-07-31

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of migraine for at least a year prior to screening.
• Experiences 2-10 migraine headaches per month (with at least 24 hours between episodes) and no more than 15 headache days per month in the 3 months prior to screening.
• Ability and willingness to arrive at the investigator's center within 1 hour (±5 min) of migraine pain onset (defined as pain that is consistent with the subject's usual migraine and is of at least moderate severity).
• Ability and willingness to abstain from taking medications not allowed by the protocol and to meet phone and check-in criteria.
• Ability and willingness to undergo a comprehensive urine toxicology screen for both licit and illicit drugs.
• Ability and willingness to complete a migraine-history diary from screening to treatment with study drug and a migraine-treatment diary from discharge through the remainder of the 24-hour period following study-drug treatment.

You may not qualify if…

• Unstable or uncontrolled significant metabolic, hepatic, renal, hematological, pulmonary, gastrointestinal, urological, neurological (except migraine headaches), or psychiatric disorders.
• Severe or acute cardiovascular or cerebrovascular disease, uncontrolled hypertension, or basilar or hemiplegic migraines.
• History of hypersensitivity, allergies, or nonresponse to valproic acid.
• Have taken VPA or other AED in the 30 days prior to screening, or are taking a migraine prophylaxis treatment other than a stable dose of propranolol or tricyclic antidepressant.
• Migraine attacks that in the investigator's opinion are associated with intractable nausea and/or vomiting.
• Any acute or chronic condition that in the investigator's opinion would limit the subject's ability to complete and/or participate in this clinical study or would place the subject at increased risk.
• Have newly started or changed the dose of either feverfew or magnesium (above 200 mg, the amount in common daily supplements) within 3 months prior to screening.

Where it is running

• Medical Affiliated Research Center — Huntsville, Alabama, United States
• Clinical Study Centers, LLC — Little Rock, Arkansas, United States
• North County Neurological Associates — Oceanside, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• Clinical Innovations — Santa Ana, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• The New England Center for Headache — Stamford, Connecticut, United States
• University Clinical Research, Inc — Pembroke Pines, Florida, United States
• Diamond Headache Clinic — Chicago, Illinois, United States
• MedTrial Boston — Wellesley Hills, Massachusetts, United States
• Michigan Head-Pain & Neurological Institute — Ann Arbor, Michigan, United States
• Mercy Health Research — Chesterfield, Missouri, United States
• Headache Care Center/ Clinvest — Springfield, Missouri, United States
• University of Medicine and Dentistry, New Jersey School of Osteopathic Medicine — Moorestown, New Jersey, United States
• Neuroscience Center of Northern New Jersey — Morristown, New Jersey, United States
• Headache Wellness Center — Greensboro, North Carolina, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States
• Neurology Ctr. of Ohio — Toledo, Ohio, United States
• The Neurology Clinic — Portland, Oregon, United States
• Thomas Jefferson University Hospital/ Jefferson Headache Center — Philadelphia, Pennsylvania, United States
• Houston Headache Clinic — Houston, Texas, United States
• Neurology & Neurosurgery Associates of Tacoma, Inc., PS — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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