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A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)

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ClinicalTrials.gov Identifier: NCT02559895
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : September 24, 2018
Sponsor:
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 frequent episodic migraineurs.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: ALD403 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : December 2017

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)
Drug: ALD403
Experimental: ALD403 Dose Level 2
ALD403 Dose Level 2 (IV)
Drug: ALD403
Experimental: ALD403 Dose Level 3
ALD403 Dose Level 3 (IV)
Drug: ALD403
Placebo Comparator: Placebo
Placebo (IV)
Drug: Placebo



Primary Outcome Measures :
  1. Change in frequency of migraine days [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Responder rate [ Time Frame: 4 weeks ]
  2. Responder rate [ Time Frame: 12 weeks ]
  3. Laboratory variables, ECG and adverse events [ Time Frame: 56 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)
  • History of migraine ≥ 12 months with

    • ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening
    • During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary
  • No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization
  • Headache eDiary was completed on at least 25 of the 28 days prior to randomization

Exclusion Criteria:

  • Confounding pain syndromes, e.g. fibromyalgia, 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- II, 2004 Section 1), 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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02559895


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Tbilisi, Georgia, 0112
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Tbilisi, Georgia, 0160
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Tbilisi, Georgia, 0179
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Tbilisi, Georgia, 0186
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
Study Director: Tim Whitaker, MD Alder Biopharmaceuticals, Inc.

Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02559895     History of Changes
Other Study ID Numbers: ALD403-CLIN-006
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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