Multiple Sclerosis
Conditions
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.
Interventions
DRUGAnesthetic Topical Adhesive Synera
For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks. For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week
Sponsors
Brown, Theodore R., M.D., MPH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Rating | baseline and two weeks of treatment | Primary Outcome Measure •Change from baseline in rating of pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog Scale (VAS, 10 = worst pain, 0 = no pain)Pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog scale (VAS, 10 = worst pain, 0 = no pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Rating | baseline and two weeks | Average Pain Rating over 24-hours, defined as the average injection-site pain over 24-hours on a 0-10 VAS (0 = no pain, 10 = worst pain). |
Countries
United States
Participant flow
Recruitment details
multiple sclerosis clinic
Participants by arm
| Arm | Count |
|---|---|
| Anesthetic Topical Adhesive Synera Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.
For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.
Anesthetic Topical Adhesive Synera: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.
For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Anesthetic Topical Adhesive Synera |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Pain Rating
Primary Outcome Measure •Change from baseline in rating of pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog Scale (VAS, 10 = worst pain, 0 = no pain)Pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog scale (VAS, 10 = worst pain, 0 = no pain).
Time frame: baseline and two weeks of treatment
Population: completing participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthetic Topical Adhesive Synera | Pain Rating | 5.7 units on a scale | Standard Deviation 3.2 |
Secondary
Average Pain Rating
Average Pain Rating over 24-hours, defined as the average injection-site pain over 24-hours on a 0-10 VAS (0 = no pain, 10 = worst pain).
Time frame: baseline and two weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anesthetic Topical Adhesive Synera | Average Pain Rating | baseline | 2.24 units on a scale | Standard Deviation 1.74 |
| Anesthetic Topical Adhesive Synera | Average Pain Rating | 2 weeks, 30minute application | 1.23 units on a scale | Standard Deviation 1.23 |
| Anesthetic Topical Adhesive Synera | Average Pain Rating | 2 weeks, 60minute application | 1.39 units on a scale | Standard Deviation 1.49 |