Safety, Efficacy and Pharmacokinetics of ALD403

Phase 1

Completed

• Conditions: Migraine
• Interventions: Biological: ALD403; Drug: Placebo

• Registration Number: NCT01772524
• Lead Sponsor: Alder Biopharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-21
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALD403	ALD403	Single IV Dose on Day 0
Saline	Placebo	Single IV infusion on Day 0

Primary Outcome Measures

Name	Time	Method
Safety of ALD403: laboratory variables, ECG and adverse events	24 weeks	* Physical Examination; * Vital signs; * 12-lead ECG (electrocardiogram); * Clinical laboratory tests (hematology, chemistry); * Number of participants with Adverse Events

Secondary Outcome Measures

Name	Time	Method
Efficacy of ALD403	12 weeks	* Change in frequency of migraine days compared to baseline; * Responder rate; * Migraine hours; * Migraine episodes; * Migraine severity; * Use of acute migraine medications
Evaluation of Pharmacokinetics of ALD403	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

Trial Locations

Locations (25)

ACT Trials; 🇺🇸 Anaheim, California, United States

Premiere Research; 🇺🇸 Austin, Texas, United States

Collaborative Neuroscience Network, Inc.; 🇺🇸 Long Beach, California, United States

CA Medical Clinic for Headache; 🇺🇸 Santa Monica, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Segal Institute for Clinical Research; 🇺🇸 North Miami, Florida, United States

Palm Beach Research Center; 🇺🇸 West Palm Beach, Florida, United States

MedVadis Research; 🇺🇸 Watertown, Massachusetts, United States

Boston Clinical Trials; 🇺🇸 Roslindale, Massachusetts, United States

Michigan Headache & Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

SPRI; 🇺🇸 Brooklyn, New York, United States

Clinvest; 🇺🇸 Springfield, Missouri, United States

Wake Research; 🇺🇸 Raleigh, North Carolina, United States

Rochester Clinical Research, Inc.; 🇺🇸 Rochester, New York, United States

Coastal Carolina Research Center; 🇺🇸 Mt. Pleasant, South Carolina, United States

Tidewater Integrated Medical Research; 🇺🇸 Virginia Beach, Virginia, United States

Neurology Associates of Arlington; 🇺🇸 Arlington, Texas, United States

ClinSearch; 🇺🇸 Chattanooga, Tennessee, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

San Francisco Clinical Research; 🇺🇸 San Francisco, California, United States

Miami Research; 🇺🇸 Miami, Florida, United States

Seattle Women's: Health, Research, Gynecology; 🇺🇸 Seattle, Washington, United States

Community Research; 🇺🇸 Cincinnati, Ohio, United States

CRI Lifetree; 🇺🇸 Salt Lake City, Utah, United States