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Trial record 18 of 3293 for:    Louisville

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

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ClinicalTrials.gov Identifier: NCT00919217
Recruitment Status : Recruiting
First Posted : June 12, 2009
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
Cynthia Corbitt, University of Louisville

June 10, 2009
June 12, 2009
April 27, 2017
August 2008
December 2020   (Final data collection date for primary outcome measure)
number of days with appearance or worsening of symptoms [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00919217 on ClinicalTrials.gov Archive Site
timing of appearance or worsening of symptoms [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Exploratory Study on the Timing of Multiple Sclerosis (MS) Symptoms
Exploratory Study on the Timing of MS Symptoms
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.
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.
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Females with relapsing-remitting multiple sclerosis, not menopausal, neither pregnant nor nursing, not treated with steroids in the last 30 days and not on experimental medications
Relapsing Remitting Multiple Sclerosis
Not Provided
Relapsing-remitting multiple sclerosis
Females with relapsing-remitting multiple sclerosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2020
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact: Cynthia Corbitt, PhD 502-852-3915 cynthia.corbitt@louisville.edu
United States
Not Provided
Plan to Share IPD: Undecided
Cynthia Corbitt, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Cynthia Corbitt, PhD University of Louisville, Dept. Biology
University of Louisville
April 2017