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A Multicenter Assessment of ALD403 in Chronic Migraine

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: NCT02275117
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : April 25, 2019
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: ALD403 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Responder rate [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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): NCT02275117

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Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
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Study Director: Jeff TL Smith, MD Alder Biopharmaceuticals, Inc.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alder Biopharmaceuticals, Inc. Identifier: NCT02275117    
Other Study ID Numbers: ALD403-CLIN-005
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Keywords provided by Alder Biopharmaceuticals, Inc.:
Migraine Disorders
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases