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A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00240006
Enrollment
307
Registered
2005-10-17
Start date
2006-01-31
Completion date
2007-09-30
Last updated
2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Copaxone®, Shared Solutions®

Brief 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®.

Interventions

PROCEDUREShared Solutions® plus MS Center v. Shared Solutions®

Copaxone

Sponsors

Teva Neuroscience, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Males or females, 18 years of age or older. 2. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted). 3. Beginning or restarting therapy with Glatiramer Acetate (Copaxone®). 4. Willing and able to complete all procedures and evaluations related to the study. 5. Willing to provide informed consent.

Exclusion criteria

1. Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®. 2. 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. 3. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study. 4. Pregnant or trying to become pregnant, or breast feeding during the study. 5. Previously participated in this study or another clinical research study in the past 30 days.

Design outcomes

Primary

MeasureTime frame
Adherence rate of Copaxone therapy by procedural intervention90 days

Secondary

MeasureTime frame
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-compliance90 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026