A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone
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ClinicalTrials.gov Identifier: NCT00240006 |
Recruitment Status
:
Completed
First Posted
: October 17, 2005
Last Update Posted
: April 11, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Procedure: Shared Solutions® plus MS Center v. Shared Solutions® | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 307 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Shared Solutions®
|
Procedure: Shared Solutions® plus MS Center v. Shared Solutions®
Copaxone
|
Experimental: 2
Shared Solutions® and MS Center/Office Practice Partnership
|
Procedure: Shared Solutions® plus MS Center v. Shared Solutions®
Copaxone
|
- Adherence rate of Copaxone therapy by procedural intervention [ Time Frame: 90 days ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240006
Study Director: | MerriKay Oleen-Burkey, Ph.D. | Teva Neuroscience, Inc. |
Additional Information:
Responsible Party: | Siyu Liu, Senior Director of Pan Am Clinical Operations, Teva Neuroscience |
ClinicalTrials.gov Identifier: | NCT00240006 History of Changes |
Other Study ID Numbers: |
PM024 |
First Posted: | October 17, 2005 Key Record Dates |
Last Update Posted: | April 11, 2011 |
Last Verified: | April 2011 |
Keywords provided by Teva Pharmaceutical Industries:
Multiple Sclerosis Copaxone® Shared Solutions® |
Additional relevant MeSH terms:
Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Pharmaceutical Solutions Glatiramer Acetate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Antirheumatic Agents |