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An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PREVAIL)

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.
ClinicalTrials.gov Identifier: NCT02985398
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

Brief Summary:
An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine

Condition or disease Intervention/treatment Phase
Migraine Disorder Biological: ALD403 (Eptinezumab) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines
Actual Study Start Date : December 2016
Actual Primary Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
Biological: ALD403 (Eptinezumab)



Primary Outcome Measures :
  1. Laboratory variables & ECG [ Time Frame: 56 Weeks ]
    To evaluate the safety and tolerability

  2. Adverse Events [ Time Frame: 56 Weeks ]

Secondary Outcome Measures :
  1. Migraine Disability Assessment (MIDAS) [ Time Frame: 104 Weeks ]
  2. Patient Global Impression of Change (PGIC) [ Time Frame: 104 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.

Exclusion Criteria:

  • Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
  • Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
  • Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
  • History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.

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 ClinicalTrials.gov identifier (NCT number): NCT02985398


Locations
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United States, California
Research Site
San Diego, California, United States, 92108
Research Site
Santa Monica, California, United States, 90404
United States, Colorado
Research Site
Colorado Springs, Colorado, United States, 80918
United States, Florida
Research Site
Bradenton, Florida, United States, 34201
Research Site
DeLand, Florida, United States, 32720
Massachusetts
Miami, Florida, United States, 33125
Research Site
Tampa, Florida, United States, 33634
Research Site
Winter Haven, Florida, United States, 33880
United States, Kansas
Research Site
Prairie Village, Kansas, United States, 66206
United States, Massachusetts
Massachusetts
Boston, Massachusetts, United States, 02131
Research Site
North Attleboro, Massachusetts, United States, 02760
02481
Wellesley, Massachusetts, United States, 02481
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
United States, New York
Research Site
Brooklyn, New York, United States, 11229
Research Site
Rochester, New York, United States, 14609
United States, Ohio
Research Site
Dayton, Ohio, United States, 45432
United States, South Carolina
Research Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
Research Site
Fort Worth, Texas, United States, 76104
United States, Washington
Research Site
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.

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Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02985398     History of Changes
Other Study ID Numbers: ALD403-CLIN-013
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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