A Phase 4 interventional study of Anesthetic Topical Adhesive Synera in Multiple Sclerosis, sponsored by Brown, Theodore R., M.D., MPH. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by Brown, Theodore R., M.D., MPH · Phase 4, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Brown, Theodore R., M.D., MPH is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 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
Also known as: Synera
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
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
multiple sclerosis clinic
| Milestone | Anesthetic Topical Adhesive Synera |
|---|---|
| Started | 30 |
| Completed | 29 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
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).
| units on a scale | Anesthetic Topical Adhesive Synera |
|---|---|
| Pain Rating | 5.7 ± 3.2 |
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).
| units on a scale | Anesthetic Topical Adhesive Synera |
|---|---|
| baseline | 2.24 ± 1.74 |
| 2 weeks, 30minute application | 1.23 ± 1.23 |
| 2 weeks, 60minute application | 1.39 ± 1.49 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anesthetic Topical Adhesive Synera | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) |
| Event | Anesthetic Topical Adhesive Synera |
|---|---|
| dizzinessNervous system disorders | 1/30 |
| Age, Categorical(Participants) | Anesthetic Topical Adhesive Synera |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 3 |
| Age, Continuous(years) | Anesthetic Topical Adhesive Synera |
|---|---|
| Mean | 51 ± 10.6 |
| Sex: Female, Male(Participants) | Anesthetic Topical Adhesive Synera |
|---|---|
| Female | 26 |
| Male | 4 |
| Region of Enrollment(Participants) | Anesthetic Topical Adhesive Synera |
|---|---|
| United States | 30 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brown, Theodore R., M.D., MPH