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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00172094
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 13, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Headache Drug: NPS 1776 (800 mg) Drug: PLACEBO Drug: NPS 1776 (400 mg) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches
Study Start Date : December 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Placebo Comparator: 1
Placebo in non-carbonated fruit flavored drink (150 ml)

Experimental: 2
400 mg 1776 powder
Drug: NPS 1776 (400 mg)
NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
Other Name: NPS1776

Experimental: 3
1776 (800 mg)
Drug: NPS 1776 (800 mg)
NPS 1776 (800 mg) powder
Other Name: NPS 1776

Primary Outcome Measures :
  1. 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] [ Time Frame: 2 hours post-dose ]

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

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00172094

  Hide Study 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
Principal Investigator: Stephen D. Silberstein, M.D. Jefferson Headache Center

Additional Information:
Responsible Party: Shire Identifier: NCT00172094     History of Changes
Other Study ID Numbers: CL1776-005
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: September 2005

Keywords provided by Shire:

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