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

This study is currently recruiting participants.
Verified July 2013 by University of Louisville
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00919217
First received: June 10, 2009
Last updated: July 30, 2013
Last verified: July 2013

June 10, 2009
July 30, 2013
August 2008
December 2015   (final data collection date for primary outcome measure)
number of days with appearance or worsening of symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Same as current
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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
Time Perspective: Prospective
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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.
 
Recruiting
80
December 2015
December 2015   (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
Female
18 Years to 50 Years
No
Contact: Cynthia Corbitt, PhD 502-852-3915 cynthia.corbitt@louisville.edu
United States
 
NCT00919217
08.0172
Yes
University of Louisville
University of Louisville
Not Provided
Principal Investigator: Cynthia Corbitt, PhD University of Louisville, Dept. Biology
University of Louisville
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP