Status:
COMPLETED
Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications
Lead Sponsor:
Brown, Theodore R., M.D., MPH
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will reduce the injection pain. Relieving injection site pain may improve the tolerability of Multiple Sclerosi...
Detailed Description
Open-label prospective study of Synera to reduce injection pain in 30 patients with relapsing forms of Multiple Sclerosis taking interferon beta or glatiramer acetate. The duration will be 3-6 weeks (...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Multiple Sclerosis based on McDonald or Poser criteria (no sub-type restrictions)
- Aged \>18
- Regular use of one of the follow Multiple Sclerosis medication treatments: interferon beta subcutaneous (15 subjects, Betaseron, Extavia or Rebif), or glatiramer acetate subcutaneous (15 subjects, Copaxone).
- No change in disease modifying therapy in 60 days.
- Mean score of ≥1.0 on Local Injection Site Reaction scale and Mean Pain Upon Injection score ≥4.0 during baseline period.
- At least 4 valid diary entries over screening period.
- No Multiple Sclerosis exacerbation for 60 days prior to screening.
- Written informed consent
Exclusion
- Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
- Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
- Concurrent application of any topical medication to treat injection site reactions from screening through final visit.
- History of allergy to lidocaine, tetracaine or PABA (para-amino benzoic acid) containing products.
- Patients receiving class 1 antiarrhythmic agents (i.e. tocainide, mexiletine)
- Any other serious and/or unstable medical condition
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01834586
Start Date
March 1 2013
End Date
March 1 2015
Last Update
April 10 2018
Active Locations (1)
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1
MS Center at Evergreen Health
Kirkland, Washington, United States, 98034