A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
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®.
1 other identifier
interventional
50
1 country
6
Brief Summary
This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 multiple-sclerosis
Started Aug 2005
Shorter than P25 for phase_4 multiple-sclerosis
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 22, 2005
CompletedFirst Posted
Study publicly available on registry
October 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFebruary 6, 2017
February 1, 2017
4 months
September 22, 2005
February 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 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
2-week diaries kept by the patients for Period 1 and for Period 2
Study Arms (2)
1
EXPERIMENTALskin reactions with the use of warm compress prior to performing a Copaxone® injection
2
EXPERIMENTALskin reactions without the use of warm compress prior to performing a Copaxone® injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Fullerton Neurology & Headache Center
Fullerton, California, United States
Neurological Center of South Florida
Miami, Florida, United States
Springfield Neurology Associates
Springfield, Massachusetts, United States
Multiple Sclerosis Care Center
Brooklyn, New York, United States
Advanced Neurosciences Institute
Nashville, Tennessee, United States
Virginia Beach Neurology
Virginia Beach, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MerriKay Oleen-Burkey, Ph.D
Teva Neuroscience, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 22, 2005
First Posted
October 17, 2005
Study Start
August 1, 2005
Primary Completion
December 1, 2005
Study Completion
February 1, 2006
Last Updated
February 6, 2017
Record last verified: 2017-02