Trial record 25 of 3547 for:    Louisville | ( Map: United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00919217
Recruitment Status : Recruiting
First Posted : June 12, 2009
Last Update Posted : June 19, 2018
Information provided by (Responsible Party):
Cynthia Corbitt, University of Louisville

Brief Summary:
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.

Condition or disease
Relapsing Remitting Multiple Sclerosis

Detailed 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.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Exploratory Study on the Timing of MS Symptoms
Study Start Date : August 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. number of days with appearance or worsening of symptoms [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. timing of appearance or worsening of symptoms [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00919217

Contact: Cynthia Corbitt, PhD 502-852-3915

United States, Kentucky
University of Louisville (recruiting nationwide) Recruiting
Louisville, Kentucky, United States, 40292
Contact: Cynthia Corbitt, PhD    502-852-3915   
Principal Investigator: Cynthia Corbitt, PhD         
Sponsors and Collaborators
University of Louisville
Principal Investigator: Cynthia Corbitt, PhD University of Louisville, Dept. Biology

Responsible Party: Cynthia Corbitt, Associate Professor, University of Louisville Identifier: NCT00919217     History of Changes
Other Study ID Numbers: 08.0172
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Cynthia Corbitt, University of Louisville:
Multiple Sclerosis
Relapsing-remitting multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases