Trial Outcomes & Findings for Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications (NCT NCT01834586)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

baseline and two weeks of treatment

Results posted on

2018-04-10

Participant Flow

multiple sclerosis clinic

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anesthetic Topical Adhesive Synera n=30 Participants 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Age, Continuous	51 years STANDARD_DEVIATION 10.6 • n=99 Participants
Sex: Female, Male Female	26 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Region of Enrollment United States	30 Participants n=99 Participants

PRIMARY outcome

Timeframe: baseline and two weeks of treatment

Population: completing participants

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).

Outcome measures

Outcome measures
Measure	Anesthetic Topical Adhesive Synera n=29 Participants 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
Pain Rating	5.7 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Anesthetic Topical Adhesive Synera n=29 Participants 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
Average Pain Rating baseline	2.24 units on a scale Standard Deviation 1.74
Average Pain Rating 2 weeks, 30minute application	1.23 units on a scale Standard Deviation 1.23
Average Pain Rating 2 weeks, 60minute application	1.39 units on a scale Standard Deviation 1.49

Adverse Events

Anesthetic Topical Adhesive Synera

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anesthetic Topical Adhesive Synera n=30 participants at risk 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
Nervous system disorders dizziness	3.3% 1/30 • Number of events 2

Additional Information

Theodore Brown

EvergreenHealth Multiple Sclerosis Center

Phone: 425-8995350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place