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Assessing Tolerability of Avonex Intramuscular Injections

Information source: Saint Francis Care
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Avonex (Drug)

Phase: N/A

Status: Completed

Sponsored by: Saint Francis Care

Official(s) and/or principal investigator(s):
Peter B Wade, MD, Principal Investigator, Affiliation: Mandell Center for Multiple Sclerosis

Summary

The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.

Clinical Details

Official title: Assessing Tolerability of Avonex Intramuscular Injects With a 25 Gauge Needle Versus 30 Gauge Needle

Study design: Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Change in patient VAS score

Secondary outcome: Ease of use

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

The Mandell Center for Multiple Sclerosis, Hartford, Connecticut 06112, United States
Additional Information

Starting date: May 2012
Last updated: March 16, 2015

Page last updated: August 20, 2015

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