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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01834586
• Date of registration: 02/04/2013
• Prospective Registration: No
• Primary sponsor: Brown, Theodore R., M.D., MPH
• Public title: Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications OUCH
• Scientific title: Pilot Study of Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (OUCH)
• Date of first enrolment: March 2013
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01834586
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Theodore R Brown, MD, MPH
• Affiliation: Evergreen Health

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Anesthetic Topical Adhesive Synera

Primary Outcome(s)

Pain Rating [Time Frame: baseline and two weeks of treatment]

Secondary Outcome(s)

Average Pain Rating [Time Frame: baseline and two weeks]

Secondary ID(s)

TRB 2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01834586