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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anesthetic Topical Adhesive Synera | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthetic Topical Adhesive Synera | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline and two weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline and two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore R Brown, MD, MPH | Evergreen Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Center at Evergreen Health | Kirkland | Washington | 98034 | United States |
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multiple sclerosis clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | completing participants | Posted | Mean | Standard Deviation | units on a scale | baseline and two weeks of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theodore Brown | EvergreenHealth Multiple Sclerosis Center | 425-8995350 | trbrown@evergreenhealth.com |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | geographic location | Count of Participants | Participants |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | baseline and two weeks |
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| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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