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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240006
• Other study ID #: PM024
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: April 8, 2011
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: September 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• Shared Solutions® plus MS Center v. Shared Solutions®
Copaxone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Neuroscience, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rate of Copaxone therapy by procedural intervention		90 days	No
Secondary	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		90 days	No

External Links

•   For more information about Multiple Sclerosis
•   For more information about Shared Solutions
•   For more information about Teva Neuroscience, Inc.