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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown, Theodore R., M.D., MPH
• Treatments: Anesthetics; Anesthetics, Local; Glatiramer Acetate; Interferon-beta

Criteria

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