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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by University of Louisville.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
First received: June 10, 2009
Last updated: July 30, 2013
Last verified: July 2013
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.

Relapsing Remitting Multiple Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Exploratory Study on the Timing of MS Symptoms

Resource links provided by NLM:

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • number of days with appearance or worsening of symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • timing of appearance or worsening of symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Relapsing-remitting multiple sclerosis
Females with 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.

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919217

Contact: Cynthia Corbitt, PhD 502-852-3915 cynthia.corbitt@louisville.edu

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

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00919217     History of Changes
Other Study ID Numbers: 08.0172 
Study First Received: June 10, 2009
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2016