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

CompletedPhase 4Relapsing MSNCT00240006

What it found

No results found

We found no results in the registry or in papers.

This trial finished 19 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Shared Solutions® plus MS Center v. Shared Solutions®

What it measured

Main measures

  • Adherence rate of Copaxone therapy by procedural intervention

    90 days

    Quality of life (reported by participants)

Other measures (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

    90 days

    Mood and sleepQuality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Jan 2006

    2. Main results due

      Jan 2007

    3. Finished

      Sept 2007

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