Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2013 |
| End Date: | March 2015 |
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.
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.
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 (1-2 weeks of baseline observation followed by 2-4 weeks of on-drug
observation), depending on which Multiple Sclerosis drug product is being studied. The study
will include down-titration from 60 to 30 minutes of application to assess for any difference
in responses. We define one primary outcome measure,"pain upon injection" by visual analog
scale (VAS). Secondary measures will include 24-hour ratings of pain by VAS and 24-hour local
injection site reaction (LISR) scale score.
forms of Multiple Sclerosis taking interferon beta or glatiramer acetate. The duration will
be 3-6 weeks (1-2 weeks of baseline observation followed by 2-4 weeks of on-drug
observation), depending on which Multiple Sclerosis drug product is being studied. The study
will include down-titration from 60 to 30 minutes of application to assess for any difference
in responses. We define one primary outcome measure,"pain upon injection" by visual analog
scale (VAS). Secondary measures will include 24-hour ratings of pain by VAS and 24-hour local
injection site reaction (LISR) scale score.
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
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