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

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Procedure: Shared Solutions® plus MS Center v. Shared Solutions®

• Registration Number: NCT00240006
• Lead Sponsor: Teva Neuroscience, Inc.

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Study Start: 2006-01
• Primary Completion: 2007-01
• Study Completion: 2007-09
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Shared Solutions® plus MS Center v. Shared Solutions®	Shared Solutions®
2	Shared Solutions® plus MS Center v. Shared Solutions®	Shared Solutions® and MS Center/Office Practice Partnership

Primary Outcome Measures

Name	Time	Method
Adherence rate of Copaxone therapy by procedural intervention	90 days

Secondary Outcome Measures

Name	Time	Method
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