Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)
Pilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)
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 Sclerosis medications.
Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings as measured by the visual analog scale and Local injection site reaction scale.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Washington
-
Kirkland, Washington, United States, 98034
- MS Center at Evergreen Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Anesthetic Topical Adhesive Synera
Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks. For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week. |
For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks. For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Rating
Time Frame: baseline and two weeks of treatment
|
Primary Outcome Measure •Change from baseline in rating of pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog Scale (VAS, 10 = worst pain, 0 = no pain)Pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog scale (VAS, 10 = worst pain, 0 = no pain). |
baseline and two weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Pain Rating
Time Frame: baseline and two weeks
|
Average Pain Rating over 24-hours, defined as the average injection-site pain over 24-hours on a 0-10 VAS (0 = no pain, 10 = worst pain).
|
baseline and two weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Theodore R Brown, MD, MPH, Evergreen Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRB 2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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