Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications

Completed · Phase 4

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01834586

Run by

Brown, Theodore R., M.D., MPH

People needed

30

Starts

2013-03-01

Expected to finish

2015-03-01

Last updated by the study team

2018-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MS Center at Evergreen Health — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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