Multiple SclerosisNCT01641120
Assessing Tolerability of Avonex Intramuscular Injections
A study testing Avonex in people with Multiple Sclerosis, run by Trinity Health Of New England at 1 site in United States.
Trial summary
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Avonex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Mandell Center for Multiple Sclerosis
Hartford, Connecticut, 06112
About this study
Official title: Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
- Conditions
- Multiple Sclerosis
- Being tested
- Avonex
- Keywords
- Multiple Sclerosis, Intramuscular Injections, Relapsing Remitting
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvonexDrug
Also called Interferon beta-1a
Intramuscular injection administered using 25 gauge or 30 gauge needle
| Study group | Role | What they receive |
|---|---|---|
| 30 gauge | Experimental | Subjects used a 30 gauge needle for intramuscular injection of Avonex. Receives: Drug: Avonex |
| 25 gauge | Experimental | Subjects used a 25 gauge needle for intramuscular injection of Avonex. Receives: Drug: Avonex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
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.
Measured: Weeks 2, 3, 4, 5
Visual Analog Scale Score for Post-injection Pain
The 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.
Measured: Weeks 2, 3, 4, 5
Secondary outcomes (2)
Fear of Injection
Secondary 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.
Measured: Weeks 2, 3, 4, 5
Perception of Needle
Secondary 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.
Measured: Weeks 2, 3, 4, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Peter B Wade, MD, Principal investigator, Mandell Center for Multiple Sclerosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641120
- Sponsor's protocol ID
- 11-12-002
- Status last verified
- Dec 2015
- First submitted
- 6 Jul 2012
- Last updated
- 1 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle
- ClinicalTrials.gov ID
- NCT01641120
- Acronym / sponsor ID
- 11-12-002
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Intramuscular Injections, Relapsing Remitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 1 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 gauge | Experimental | Drug: AvonexSubjects used a 30 gauge needle for intramuscular injection of Avonex. |
| 25 gauge | Experimental | Drug: AvonexSubjects used a 25 gauge needle for intramuscular injection of Avonex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvonexAlso: Interferon beta-1aIntramuscular injection administered using 25 gauge or 30 gauge needle | Drug | 25 gauge, 30 gauge |
Primary outcome
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
Time frame: Weeks 2, 3, 4, 5
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.
Visual Analog Scale Score for Post-injection Pain
Time frame: Weeks 2, 3, 4, 5
The 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.
2 secondary outcomes
Fear of Injection
Time frame: Weeks 2, 3, 4, 5
Perception of Needle
Time frame: Weeks 2, 3, 4, 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter B Wade, MD principal investigator
Mandell Center for Multiple Sclerosis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avonex in people with Multiple Sclerosis, run by Trinity Health Of New England at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety (time frame: Weeks 2, 3, 4, 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.