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Completed

NCT Number: NCT00239993

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fullerton Neurology & Headache Center, Fullerton, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Taking any other immunomodulatory therapy in conjunction with Copaxone®.
  • 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.
  • Any situation which the investigator or nurse feels may interfere with participation in the study.
  • Pregnant, or trying to become pregnant, or breast feeding during the study.
  • Previously participated in this study.

Treatment and study plan

Glatiramer Acetate

Drug

Other names: Copaxone

Warm compress prior to injection of glatiramer acetate

Procedure

Other names: Copaxone

Primary outcomes

  1. The number of local injection site reactions (LISRs) noted at 5-minutes post-injection

    Time frame: 2-week diaries kept by the patients for Period 1 and for Period 2

Secondary outcomes

  1. The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection

    Time frame: 2-week diaries kept by the patients for Period 1 and for Period 2

Sponsors and collaborators

Lead sponsor

Teva Neuroscience, Inc.

Industry

Registry information

Official study title

An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Oct 17, 2005
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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