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

Alder Biopharmaceuticals, Inc.25 sites in 1 country163 target enrollmentJanuary 2013

ConditionsMigraine

InterventionsALD403 Placebo

DrugsPlacebo

Overview

Phase: Phase 1
Intervention: ALD403
Conditions: Migraine
Sponsor: Alder Biopharmaceuticals, Inc.
Enrollment: 163
Locations: 25
Primary Endpoint: Safety of ALD403: laboratory variables, ECG and adverse events
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

February 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alder Biopharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

ALD403

Single IV Dose on Day 0

Intervention: ALD403

Saline

Single IV infusion on Day 0

Intervention: Placebo

Outcomes

Primary Outcomes

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