N/A
Completed N=20
Assessing Tolerability of Avonex Intramuscular Injections
Source: ClinicalTrials.gov NCT01641120 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Change in Patient Visual Analog Scale Score for Pre-injection Anxiety — 1.58; 2.22 cm — p=<.05
Summary
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Visual Analog Scale Score for Pre-injection Anxiety |
1.58; 2.22 | <.05 sig |
| PRIMARY Visual Analog Scale Score for Post-injection Pain |
1.201; 0.764 | 0.035 sig |
| SECONDARY Fear of Injection |
1.38; 1.41 | 0.193 |
| SECONDARY Perception of Needle |
2.58; 1.94 | .005 sig |
Eligibility Criteria
Inclusion Criteria
- Between 18 - 65 years of age;
- Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis;
- Currently being treated with Avonex® for at least 90 days;
- Using 25 gauge needles for injection of Avonex® for at least 90 days;
- Willing and able to complete study questionnaires; and
- Provided informed consent to participate in this study
Exclusion Criteria
- Diagnosis of Progressive Multiple Sclerosis;
- History of recent illness or infection;
- History of allergic reaction to Avonex®;
- Any prior usage of a 30 gauge needle for administration of Avonex®;
- Concurrent treatment with other immunomodulating therapies;
- Pregnant or planning on becoming pregnant;
- Nursing mothers; and
- Unable to complete the requirements of the study
Data sourced from ClinicalTrials.gov (NCT01641120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.