Safety, Efficacy and Pharmacokinetics of ALD403

January 6, 2016 updated by: Alder Biopharmaceuticals, Inc.

A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 1b Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • Premiere Research
    • California
      • Anaheim, California, United States, 92801
        • ACT Trials
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network, Inc.
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research
      • Santa Monica, California, United States, 90404
        • CA Medical Clinic for Headache
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Miami, Florida, United States, 33143
        • Miami Research
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Massachusetts
      • Roslindale, Massachusetts, United States, 02131
        • Boston Clinical Trials
      • Watertown, Massachusetts, United States, 02472
        • MedVadis Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Headache & Neurological Institute
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest
    • New York
      • Brooklyn, New York, United States, 11235
        • SPRI
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Community Research
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch
    • Texas
      • Arlington, Texas, United States, 76017
        • Neurology Associates of Arlington
      • Austin, Texas, United States, 78705
        • Premiere Research
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • CRI Lifetree
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Tidewater Integrated Medical Research
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Women's: Health, Research, Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

  • History of migraine ≥ 12 months with

    • ≥ 5 and ≤ 14 migraine days in each 28 day period in the 3 months prior to screening
    • use of acute migraine medications ≤ 14 days per 28 day period and, within those days, ≤ 10 days of triptan use per 28 day period in the 3 months prior to screening and the 28 day period of completion of eDiary prior to randomization
  • Women of child-bearing potential and males with partners of child-bearing potential must agree to use adequate contraception (oral or injectable [depot] estrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method [e.g., condom and diaphragm or spermicidal gel]). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before screening
  • Any hormonal therapy (e.g., oral contraceptives, hormone replacement therapy) use is stable and ongoing for at least 3 months prior to screening and during the 28 day period from screening to randomization
  • Agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., Facebook, Twitter) until the trial has been completed

Exclusion Criteria

  • Confounding pain syndromes including fibromyalgia, chronic musculoskeletal (e.g., low back pain), psychiatric conditions, dementia, or major neurological disorders other than migraine that interfere with the participation in the trial
  • Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, basilar, hemiplegic, or familial hemiplegic migraine
  • Regular use (greater than 7 days) of prophylactic headache medication (any preventive medication or supplement with evidence of efficacy from at least 1 placebo-controlled trial) within 3 months, or onabotulinumtoxin A within 6 months prior to screening or during the 28 day period prior to randomization
  • Cardiac surgery or cardiac symptoms within 3 months of screening and during the 28 day period prior to randomization
  • Suspected or diagnosis of hypertension with or without antihypertensive treatment
  • Any ongoing co-morbidity that in the opinion of the Investigator will interfere with the participation in the trial
  • Body Mass Index (BMI) > 39 at screening
  • Pregnant, breast-feeding, or planning to become pregnant during the trial
  • Patients who have used opioids > 5 days for the treatment of pain in more than 2 of the 6 months prior to screening or in the 28 day period prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALD403
Single IV Dose on Day 0
Biological: ALD403
Placebo Comparator: Saline
Single IV infusion on Day 0
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of ALD403: laboratory variables, ECG and adverse events
Time Frame: 24 weeks
  • Physical Examination
  • Vital signs
  • 12-lead ECG (electrocardiogram)
  • Clinical laboratory tests (hematology, chemistry)
  • Number of participants with Adverse Events
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Pharmacokinetics of ALD403
Time Frame: 24 weeks
  • Cmax - maximum plasma concentration
  • Tmax - Time to achieve maximum plasma concentration
  • AUC - Area under the plasma concentration-time curve
  • T1/2 - Elimination half-life
  • Vz - Volume of distribution
  • CL - Clearance
  • Bioavailability
  • Plasma levels of unbound ALD403
24 weeks
Efficacy of ALD403
Time Frame: 12 weeks
  • Change in frequency of migraine days compared to baseline
  • Responder rate
  • Migraine hours
  • Migraine episodes
  • Migraine severity
  • Use of acute migraine medications
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alder Biopharmaceuticals, Inc.

Investigators

  • Study Director: Jeff Smith, MD, Alder Biopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALD403-CLIN-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe