Phase 4
N=30
Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01834586 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Pain Rating — 5.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Anesthetic Topical Adhesive Synera (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown, Theodore R., M.D., MPH
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Rating |
5.7 | — |
| SECONDARY Average Pain Rating |
2.24; 1.23; 1.39 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01834586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.