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

NCT ID: NCT00240006

Last Updated: 2011-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Shared Solutions®

Group Type EXPERIMENTAL

Shared Solutions® plus MS Center v. Shared Solutions®

Intervention Type PROCEDURE

Copaxone

2

Shared Solutions® and MS Center/Office Practice Partnership

Group Type EXPERIMENTAL

Shared Solutions® plus MS Center v. Shared Solutions®

Intervention Type PROCEDURE

Copaxone

Interventions

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Shared Solutions® plus MS Center v. Shared Solutions®

Copaxone

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Neuroscience

Principal Investigators

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MerriKay Oleen-Burkey, Ph.D.

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Other Identifiers

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PM024

Identifier Type: -

Identifier Source: org_study_id

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