NCT00240032

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 multiple-sclerosis

Timeline
Completed

Started Oct 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 11, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

October 13, 2005

Last Update Submit

April 7, 2011

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Injection Site Reaction

    Injection site reaction after taking antihistamine

    5 weeks

Study Arms (2)

Copaxone® with Zyrtec

ACTIVE COMPARATOR
Drug: glatiramer acetate injection with oral cetirizine hydrochloride

Copaxone® with placebo

EXPERIMENTAL
Drug: glatiramer acetate with placebo

Interventions

glatiramer acetate injection with oral cetirizine hydrochlorideDRUG

Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet

Also known as: Copaxone®, Zyrtec®
Copaxone® with Zyrtec
glatiramer acetate with placeboDRUG

Copaxone® injection 20 mg, oral placebo

Also known as: Copaxone®
Copaxone® with placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • years of age or older
  • Diagnosis of RRMS
  • Beginning or recently (within \< 3months) began self-injecting Copaxone®

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Glatiramer AcetateCetirizine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsHydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • MerriKay Oleen-Burkey, Ph.D.

    Teva Neuroscience, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

October 1, 2004

Primary Completion

June 1, 2006

Study Completion

July 1, 2006

Last Updated

April 11, 2011

Record last verified: 2011-04