Multiple SclerosisPhase 4NCT00240006
A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone
A Phase 4 study testing Shared Solutions® plus MS Center v. Shared Solutions® in people with Multiple Sclerosis, run by Teva Neuroscience, Inc..
Trial summary
To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Shared Solutions® plus MS Center v. Shared Solutions®
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18 years of age or older.
- Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).
- Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).
- Willing and able to complete all procedures and evaluations related to the study.
- Willing to provide informed consent.
Who cannot join
- Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
- Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
- Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
- Pregnant or trying to become pregnant, or breast feeding during the study.
- Previously participated in this study or another clinical research study in the past 30 days.
About this study
Official title: An Open Label, Prospective Parallel Cohort Study Comparing A 90-day Copaxone® Adherence Enhancement Program Among Persons With Multiple Sclerosis Who Participate in Shared Solutions® Alone or in Partnership With Their MS Center
To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.
- Conditions
- Multiple Sclerosis
- Being tested
- Shared Solutions® plus MS Center v. Shared Solutions®
- Keywords
- Multiple Sclerosis, Copaxone®, Shared Solutions®
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Solutions® plus MS Center v. Shared Solutions®Procedure or surgery
Copaxone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Shared Solutions® Receives: Procedure: Shared Solutions® plus MS Center v. Shared Solutions® |
| 2 | Experimental | Shared Solutions® and MS Center/Office Practice Partnership Receives: Procedure: Shared Solutions® plus MS Center v. Shared Solutions® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate of Copaxone therapy by procedural intervention
Measured: 90 days
Secondary outcomes (1)
Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MerriKay Oleen-Burkey, Ph.D., Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240006
- Sponsor's protocol ID
- PM024
- Status last verified
- Apr 2011
- First submitted
- 13 Oct 2005
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Prospective Parallel Cohort Study Comparing A 90-day Copaxone® Adherence Enhancement Program Among Persons With Multiple Sclerosis Who Participate in Shared Solutions® Alone or in Partnership With Their MS Center
- ClinicalTrials.gov ID
- NCT00240006
- Acronym / sponsor ID
- PM024
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Copaxone®, Shared Solutions®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Teva Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Shared Solutions® plus MS Center v. Shared Solutions®Shared Solutions® |
| 2 | Experimental | Procedure: Shared Solutions® plus MS Center v. Shared Solutions®Shared Solutions® and MS Center/Office Practice Partnership |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females, 18 years of age or older.
- Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).
- Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).
- Willing and able to complete all procedures and evaluations related to the study.
- Willing to provide informed consent.
Key exclusion criteria (5 listed)
- Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
- Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
- Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
- Pregnant or trying to become pregnant, or breast feeding during the study.
- Previously participated in this study or another clinical research study in the past 30 days.
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 |
|---|---|---|
| Shared Solutions® plus MS Center v. Shared Solutions®Copaxone | Procedure or surgery | 1, 2 |
Primary outcome
Adherence rate of Copaxone therapy by procedural intervention
Time frame: 90 days
1 secondary outcome
Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
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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.
MerriKay Oleen-Burkey, Ph.D. study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shared Solutions® plus MS Center v. Shared Solutions® in people with Multiple Sclerosis, run by Teva Neuroscience, Inc..
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 5 inclusion and 5 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 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence rate of Copaxone therapy by procedural intervention (time frame: 90 days). 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 11 Apr 2011.