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

This study has been terminated.
Sponsor:
Information provided by:
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00172094
First received: September 9, 2005
Last updated: January 20, 2009
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Migraine Headache
Drug: NPS 1776
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:
  • The response rate at 2 hours post-dose such that the percentage of subjects whose migraine pain-intensity score is none [0] or mild [1] at 2 hours post-dose, after a baseline pain intensity of moderate [2] or severe [3]

Secondary Outcome Measures:
  • Pain-free rate at 2 hours post-dose
  • Response rate up to 48 (±24) hours post-dose
  • Recurrence rate of migraine headache within 24 hours post dose
  • Time to recurrence of migraine within 24 hours post-dose
  • Area under the migraine pain curve in visual analogue scale (VAS) 0 4 hours post-dose
  • VAS pain reduction: peak pain reduction in VAS score 0-4 hours post-dose
  • Presence of nausea/vomiting, sensitivity to sound/light, skin sensitivity (cutaneous allodynia), intracranial sensitivity
  • Brush allodynia
  • Muscle tenderness
  • Functional disability
  • Use of rescue medication
  • Time to meaningful pain relief
  • Global Subject Impression (GSI)

Estimated Enrollment: 300
Study Start Date: December 2003
Estimated Study Completion Date: June 2004
Detailed Description:

Migraine, the most common cause of recurrent severe or disabling headache, is diagnosed on the basis of a clinical history of intermittent headache with autonomic, constitutional, and neurologic disturbances.

Many antiepileptic drugs (AEDs) have demonstrated efficacy as acute and/or prophylaxis therapy for migraine, even though the mechanism of action of the various AEDs is poorly understood.

NPS 1776, isovaleramide, is a neutral aliphatic amide. The mechanism by which NPS 1776 exerts its therapeutic actions in nonclinical animal models of disease is unclear. The same is true for many antiepileptics on the market today. NPS 1776 does not appear to bind directly to various CNS receptor centers, although it shows a broad range of anticonvulsant activity in multiple animal models of seizures. This broad profile of anticonvulsant activity is similar to that of valproic acid (VPA), and may also predict NPS 1776 efficacy in the treatment of migraine.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of migraine for at least a year prior to screening.
  2. 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.
  3. 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).
  4. Ability and willingness to abstain from taking medications not allowed by the protocol and to meet phone and check-in criteria.
  5. Ability and willingness to undergo a comprehensive urine toxicology screen for both licit and illicit drugs.
  6. 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.

Exclusion Criteria:

  1. Unstable or uncontrolled significant metabolic, hepatic, renal, hematological, pulmonary, gastrointestinal, urological, neurological (except migraine headaches), or psychiatric disorders.
  2. Severe or acute cardiovascular or cerebrovascular disease, uncontrolled hypertension, or basilar or hemiplegic migraines.
  3. History of hypersensitivity, allergies, or nonresponse to valproic acid.
  4. 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.
  5. Migraine attacks that in the investigator's opinion are associated with intractable nausea and/or vomiting.
  6. 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.
  7. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172094

  Hide Study Locations
Locations
United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, California
North County Neurological Associates
Oceanside, California, United States, 92056
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
Clinical Innovations
Santa Ana, California, United States, 92705
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
United States, Connecticut
The New England Center for Headache
Stamford, Connecticut, United States, 06902
United States, Florida
University Clinical Research, Inc
pembroke Pines, Florida, United States, 33024
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
United States, Massachusetts
MedTrial Boston
Wellesley Hills, Massachusetts, United States, 02481
United States, Michigan
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Mercy Health Research
Chesterfield, Missouri, United States, 63017
Headache Care Center/ Clinvest
Springfield, Missouri, United States, 65804
United States, New Jersey
University of Medicine and Dentistry, New Jersey School of Osteopathic Medicine
Moorestown, New Jersey, United States, 08057
Neuroscience Center of Northern New Jersey
Morristown, New Jersey, United States, 07960
United States, North Carolina
Headache Wellness Center
Greensboro, North Carolina, United States, 27401
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Neurology Ctr. of Ohio
Toledo, Ohio, United States, 43623
United States, Oregon
The Neurology Clinic
Portland, Oregon, United States, 37210
United States, Pennsylvania
Thomas Jefferson University Hospital/ Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Houston Headache Clinic
Houston, Texas, United States, 77004
United States, Washington
Neurology & Neurosurgery Associates of Tacoma, Inc., PS
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
NPS Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00172094     History of Changes
Other Study ID Numbers: CL1776-005
Study First Received: September 9, 2005
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:
Migraine

Additional relevant MeSH terms:
Headache
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014