NCT01772524CompletedPhase 1
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 enrollmentStarted: January 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 163
- Locations
- 25
- Primary Endpoint
- Safety of ALD403: laboratory variables, ECG and adverse events
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ALD403
Experimental
Single IV Dose on Day 0
Intervention: ALD403 (Biological)
Saline
Placebo Comparator
Single IV infusion on Day 0
Intervention: Placebo (Drug)
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
Secondary Outcomes
- Efficacy of ALD403(12 weeks)
- Evaluation of Pharmacokinetics of ALD403(24 weeks)
Investigators
Study Sites (25)
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