Clinical trial NCT01834586: Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications
Official title: Pilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Brown, Theodore R., M.D., MPH
Sponsor class: INDIV
First posted: 2013-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Pain Rating
timeFrame: baseline and two weeks of treatment
Secondary outcomes:
measure: Average Pain Rating
timeFrame: baseline and two weeks
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: MS Center at Evergreen Health
state: Washington
Study officials:
affiliation: Evergreen Health
name: Theodore R Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: