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Exploratory Study on the Timing of Multiple Sclerosis (MS) Symptoms

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status

Enrolling

Conditions

Relapsing Remitting Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT00919217
08.0172

Details and patient eligibility

About

The investigators' overall hypothesis is that appearance or worsening of relapsing-remitting multiple sclerosis (RR-MS) symptoms are affected by various factors including stress, hormonal cycles, illness and missed medications.

Full description

Fluctuations in MS symptoms in women with RR-MS might be affected by a variety of factors. To determine which factors are important, we are asking subjects to fill out a diary and calendar on a daily basis for 90 days. After an initial instructional meeting over the phone, the materials are filled out at home and returned monthly via postage-paid envelopes provided by the study. Compensation ($10 gift card) is sent after each monthly diary is received. The diary includes a list of symptoms and a rank scale for the women to show subtle changes in MS symptoms. The calendar allows the subject to denote additional factors such as stress, hormonal cycles, illnesses or immunizations and changed or missed medications. We anticipate that statistical analysis will reveal which of these factors affect women with relapsing-remitting multiple sclerosis.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • females
  • diagnosed with relapsing-remitting multiple sclerosis

Exclusion criteria

  • male
  • no diagnosis of relapsing-remitting MS
  • diagnosis of any other autoimmune disease or fibromyalgia
  • peri-, post-, or surgically menopausal
  • pregnant within past year or nursing
  • history of chemotherapy
  • on experimental medications
  • treatment with steroids in the last 30 days

Trial design

80 participants in 1 patient group

Relapsing-remitting multiple sclerosis
Description:
Females with relapsing-remitting multiple sclerosis

Trial contacts and locations

1

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Central trial contact

Cynthia Corbitt, PhD

Data sourced from clinicaltrials.gov

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