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A Multicenter Assessment of ALD403 in Chronic Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02275117
First received: October 20, 2014
Last updated: February 17, 2017
Last verified: May 2016
  Purpose
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.

Condition Intervention Phase
Migraine Disorders
Biological: ALD403
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine

Resource links provided by NLM:


Further study details as provided by Alder Biopharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in migraine days from baseline to week 12. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Evaluate safety of ALD403: laboratory variables, ECG and adverse events [ Time Frame: 49 weeks ]
  • Cmax - Peak plasma concentration of ALD403 [ Time Frame: 49 weeks ]
  • Tmax - Time to achieve peak plasma concentration of ALD403 [ Time Frame: 49 weeks ]
  • AUC - Area under the plasma concentration vs.time curve of ALD403 [ Time Frame: 49 weeks ]

Enrollment: 617
Study Start Date: October 2014
Study Completion Date: November 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALD403 Dose Level 1
ALD403 Dose Level 1 (IV)
Biological: ALD403
Experimental: ALD403 Dose Level 2
ALD403 Dose Level 2 (IV)
Biological: ALD403
Experimental: ALD403 Dose Level 3
ALD403 Dose Level 3 (IV)
Biological: ALD403
Experimental: ALD403 Dose Level 4
ALD403 Dose Level 4 (IV)
Biological: ALD403
Placebo Comparator: Placebo
Placebo (IV)
Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year
  • During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
  • Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Exclusion Criteria:

  • Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome) or any pain syndrome that requires regular analgesia
  • Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening.
  • History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
  • Unable to differentiate migraine from other headaches
  • Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.
  • Have any clinically significant concurrent medical condition
  • Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
  • Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
  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: NCT02275117

  Hide Study Locations
Locations
United States, Alabama
Research Site
Huntsville, Alabama, United States, 35801
Research Site
Mobile, Alabama, United States, 36608
United States, Alaska
Research Site
Little Rock, Alaska, United States, 72211
United States, Arizona
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Phoenix, Arizona, United States, 85027
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Scottsdale, Arizona, United States, 85259
United States, Arkansas
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Hot Springs, Arkansas, United States, 71901
United States, California
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Anaheim, California, United States, 92801
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Encino, California, United States, 91436
Reserach Site
Long Beach, California, United States, 90806
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Los Angeles, California, United States, 90036
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Oakland, California, United States, 94612
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San Diego, California, United States, 92108
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San Francisco, California, United States, 94102
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Santa Monica, California, United States, 90404
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Stanford, California, United States, 94305
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Ventura, California, United States, 93003
United States, Colorado
Research Site
Colorado Springs, Colorado, United States, 80918
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Denver, Colorado, United States, 80210
United States, Connecticut
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Stamford, Connecticut, United States, 06905
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Waterbury, Connecticut, United States, 06708
United States, Florida
Research Site
Gainesville, Florida, United States, 32607
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Hallandale Beach, Florida, United States, 33009
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Jacksonville, Florida, United States, 32256
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33173
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North Miami, Florida, United States, 33161
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Orlando, Florida, United States, 32801
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Orlando, Florida, United States, 32806
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Tampa, Florida, United States, 33606
United States, Georgia
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Atlanta, Georgia, United States, 30022
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Atlanta, Georgia, United States, 30342
United States, Illinois
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Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 60640
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Evansville, Illinois, United States, 47714
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Normal, Illinois, United States, 61761
United States, Kansas
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Prairie Village, Kansas, United States, 66206
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Wichita, Kansas, United States, 67207
United States, Kentucky
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Louisville, Kentucky, United States, 40207
United States, Louisiana
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New Orleans, Louisiana, United States, 70115
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Shreveport, Louisiana, United States, 71105
United States, Massachusetts
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Boston, Massachusetts, United States, 21310
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Brockton, Massachusetts, United States, 02301
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New Bedford, Massachusetts, United States, 02740
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Watertown, Massachusetts, United States, 02472
United States, Michigan
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Ann Arbor, Michigan, United States, 48104
United States, Missouri
Research Site
Springfield, Missouri, United States, 65807
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St. Louis, Missouri, United States, 63141
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68134
United States, New Jersey
Research Site
Princeton, New Jersey, United States, 08540
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Research Site
Albany, New York, United States, 12208
Research Site
Amherst, New York, United States, 14226
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Bronx, New York, United States, 10461
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Brooklyn, New York, United States, 11235
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Endwell, New York, United States, 13760
Research Site
New York, New York, United States, 10019
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Rochester, New York, United States, 14609
United States, North Carolina
Research Site
Cary, North Carolina, United States, 27518
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Research Site
Canton, Ohio, United States, 44718
Research Site
Cincinnati, Ohio, United States, 45255
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Cleveland, Ohio, United States, 44195
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Columbus, Ohio, United States, 43213
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Dayton, Ohio, United States, 45424
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19107
Research Site
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Research Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37421
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Memphis, Tennessee, United States, 38119
United States, Texas
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Austin, Texas, United States, 78705
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Dallas, Texas, United States, 75231
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77058
United States, Utah
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Orem, Utah, United States, 84058
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Salt Lake City, Utah, United States, 84109
United States, Virginia
Research Site
Richmond, Virginia, United States, 23226
Research Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Research Site
Bellevue, Washington, United States, 98007
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Seattle, Washington, United States, 98105
Research Site
Tacoma, Washington, United States, 98405
Australia
Research Site
New South Wales, Australia, 2031
Research Site
Victoria, Australia, 3004
Research Site
Victoria, Australia, 3050
Research Site
WA, Australia, 6009
Georgia
Research Site
Tbilisi, Georgia, 0112
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Tbilisi, Georgia, 0160
Research Site
Tbilisi, Georgia, 0186
New Zealand
Research Site
Auckland, New Zealand, 8963
Research Site
Christchurch, New Zealand, 2856
Research Site
Hamilton, New Zealand, 3204
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
Study Director: Jeff TL Smith, MD Alder Biopharmaceuticals, Inc.
  More Information

Additional Information:
Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02275117     History of Changes
Other Study ID Numbers: ALD403-CLIN-005
Study First Received: October 20, 2014
Last Updated: February 17, 2017

Keywords provided by Alder Biopharmaceuticals, Inc.:
Migraine Disorders
ALD403

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 26, 2017