A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

Teva Branded Pharmaceutical Products R&D, Inc.80 enrolled

Overview

This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

glatiramer acetate injection with oral cetirizine hydrochloride

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female * 18 years of age or older * Diagnosis of RRMS * Beginning or recently (within \< 3months) began self-injecting Copaxone® Exclusion Criteria: * Taking any other immunomodulatory therapy in conjunction with Copaxone® * Unable to perform subcutaneous self-injection * Pregnant or trying to become pregnant, or breast feeding during the study * Previously participated in this study or in another clinical trial in the past 30 days

A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes