A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: glatiramer acetate; Procedure: Warm compress prior to injection of glatiramer acetate

• Registration Number: NCT00239993
• Lead Sponsor: Teva Neuroscience, Inc.

Brief Summary

This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Primary Completion: 2005-12
• Study Completion: 2006-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male or Female, 18 years or older, with a diagnosis of RRMS
2. Willing and able to complete all procedures and evaluations related to the study.
3. Willing to provide Informed Consent

Exclusion Criteria

1. Taking any other immunomodulatory therapy in conjunction with Copaxone®.
2. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
3. Any situation which the investigator or nurse feels may interfere with participation in the study.
4. Pregnant, or trying to become pregnant, or breast feeding during the study.
5. Previously participated in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	glatiramer acetate	skin reactions with the use of warm compress prior to performing a Copaxone® injection
2	Warm compress prior to injection of glatiramer acetate	skin reactions without the use of warm compress prior to performing a Copaxone® injection

Primary Outcome Measures

Name	Time	Method
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection	2-week diaries kept by the patients for Period 1 and for Period 2

Secondary Outcome Measures

Name	Time	Method
The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection	2-week diaries kept by the patients for Period 1 and for Period 2

Trial Locations

Locations (6)

Neurological Center of South Florida; 🇺🇸 Miami, Florida, United States

Advanced Neurosciences Institute; 🇺🇸 Nashville, Tennessee, United States

Multiple Sclerosis Care Center; 🇺🇸 Brooklyn, New York, United States

Virginia Beach Neurology; 🇺🇸 Virginia Beach, Virginia, United States

Fullerton Neurology & Headache Center; 🇺🇸 Fullerton, California, United States

Springfield Neurology Associates; 🇺🇸 Springfield, Massachusetts, United States