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OpenTrials
Completed

NCT Number: NCT00240006

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

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®.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shared Solutions® plus MS Center v. Shared Solutions®

Procedure

Copaxone

Primary outcomes

  1. Adherence rate of Copaxone therapy by procedural intervention

    Time frame: 90 days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Teva Neuroscience, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 17, 2005
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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