Trial Outcomes & Findings for Assessing Tolerability of Avonex Intramuscular Injections (NCT NCT01641120)
NCT ID: NCT01641120
Last Updated: 2016-02-01
Results Overview
The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.
COMPLETED
NA
20 participants
Weeks 2, 3, 4, 5
2016-02-01
Participant Flow
Participant milestones
| Measure |
25 Gauge or 30 Gauge Needle
Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3.
|
|---|---|
|
25 Gauge Needle Weeks 1, 4, 5
STARTED
|
20
|
|
25 Gauge Needle Weeks 1, 4, 5
COMPLETED
|
20
|
|
25 Gauge Needle Weeks 1, 4, 5
NOT COMPLETED
|
0
|
|
30 Gauge Needle Weeks 2 and 3
STARTED
|
20
|
|
30 Gauge Needle Weeks 2 and 3
COMPLETED
|
20
|
|
30 Gauge Needle Weeks 2 and 3
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Tolerability of Avonex Intramuscular Injections
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle
|
|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 10.41 • n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weeks 2, 3, 4, 5The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.
Outcome measures
| Measure |
25 Gauge
n=20 Participants
Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
|
30 Gauge
n=20 Participants
Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
|
|---|---|---|
|
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
|
1.58 cm
Standard Deviation 2.25
|
2.22 cm
Standard Deviation 2.73
|
PRIMARY outcome
Timeframe: Weeks 2, 3, 4, 5The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.
Outcome measures
| Measure |
25 Gauge
n=20 Participants
Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
|
30 Gauge
n=20 Participants
Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
|
|---|---|---|
|
Visual Analog Scale Score for Post-injection Pain
|
1.201 cm
Standard Deviation 1.22
|
0.764 cm
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Weeks 2, 3, 4, 5Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never). Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle.
Outcome measures
| Measure |
25 Gauge
n=20 Participants
Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
|
30 Gauge
n=20 Participants
Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
|
|---|---|---|
|
Fear of Injection
|
1.38 units on a scale
Standard Deviation 0.509
|
1.41 units on a scale
Standard Deviation 0.558
|
SECONDARY outcome
Timeframe: Weeks 2, 3, 4, 5Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree). A total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle. Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle. Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle.
Outcome measures
| Measure |
25 Gauge
n=20 Participants
Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
|
30 Gauge
n=20 Participants
Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
|
|---|---|---|
|
Perception of Needle
|
2.58 units on a scale
Standard Deviation 0.914
|
1.94 units on a scale
Standard Deviation 0.853
|
Adverse Events
25 Gauge
30 Gauge
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lindsay Tuttle, MPH
Mandell Center for Multiple Sclerosis, Mount Sinai Rehabilitation Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place