A Study Comparing Shared Solutions® Plus MS Center Suppor... | NCT00240006

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

NCT00240006

Sponsor

Teva Neuroscience, Inc.

Status

Completed

Last Update Posted

Apr 11, 2011Estimated

Enrollment

307Actual

Phase

Phase 4

Conditions

Multiple Sclerosis

Interventions

Shared Solutions® plus MS Center v. Shared Solutions®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Oct 13, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 17, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2011

Last Update Posted Date

Apr 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

307Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Shared Solutions®	Procedure: Shared Solutions® plus MS Center v. Shared Solutions®
2	Experimental	Shared Solutions® and MS Center/Office Practice Partnership	Procedure: Shared Solutions® plus MS Center v. Shared Solutions®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shared Solutions® plus MS Center v. Shared Solutions®	Procedure	Copaxone	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence rate of Copaxone therapy by procedural intervention		90 days

Secondary Outcomes

Measure	Description	Time 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-compliance		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MerriKay Oleen-Burkey, Ph.D.	Teva Neuroscience, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided