EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose

Outcome Description:

The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.

Outcome Time Frame:

baseline, 4 hours post-dose

Safety Issue:

No

Principal Investigator

Patrick Horn, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Dyax Corp.

Authority:

United States: Food and Drug Administration

Study ID:

EDEMA4 (DX-88/20)

NCT ID:

NCT00457015

Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

• Hereditary Angioedema
• Angioedema
• Angioedemas, Hereditary