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

NCT01834586 | Completed Phase 4 Results

• 1 other identifier: TRB 2012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Average Pain Rating

  baseline and two weeks

Study Arms (1)

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.

Drug: Anesthetic Topical Adhesive Synera

Interventions

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

Also known as: Synera

Anesthetic Topical Adhesive Synera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown, Theodore R., M.D., MPH: lead

Study Sites (1)

MS Center at Evergreen Health

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Theodore Brown
• Organization: EvergreenHealth Multiple Sclerosis Center

trbrown@evergreenhealth.com

425-8995350

Study Officials

• Theodore R Brown, MD, MPH

  Evergreen Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 18, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 10, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-03

Locations

US (1)