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Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)

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ClinicalTrials.gov Identifier: NCT01834586
Recruitment Status : Completed
First Posted : April 18, 2013
Results First Posted : March 13, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Brown, Theodore R., M.D., MPH

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Anesthetic Topical Adhesive Synera Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)
Study Start Date : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
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.

 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

Other Name: Synera


Outcome Measures
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Primary Outcome Measures :
  1. Pain Rating [ Time Frame: 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 Outcome Measures :
  1. Average Pain Rating [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834586


Locations
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United States, Washington
MS Center at Evergreen Health
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Brown, Theodore R., M.D., MPH
Investigators
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Principal Investigator: Theodore R Brown, MD, MPH Evergreen Health
More Information
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Responsible Party: Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier: NCT01834586    
Other Study ID Numbers: TRB 2012
First Posted: April 18, 2013    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: April 10, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs