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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 November 2010 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00919217
First received: June 10, 2009
Last updated: November 23, 2010
Last verified: November 2010
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

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

Criteria

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

Contacts
Contact: Surya Veluvolu, MD 502-994-7723 s0velu02@louisville.edu
Contact: Cynthia Corbitt, PhD 502-852-3915 cynthia.corbitt@louisville.edu

Locations
United States, Kentucky
University of Louisville (recruiting nationwide) Recruiting
Louisville, Kentucky, United States, 40292
Contact: Surya Veluvolu, MD     502-994-7723     s0velu02@louisville.edu    
Contact: Cynthia Corbitt, PhD     502-852-3915     cynthia.corbitt@louisville.edu    
Principal Investigator: Cynthia Corbitt, PhD            
Sponsors and Collaborators
University of Louisville
Bayer
Investigators
Principal Investigator: Cynthia Corbitt, PhD University of Louisville, Dept. Biology
  More Information

No publications provided

Responsible Party: Cynthia Corbitt, PhD, University of Louisville, Department of Biology
ClinicalTrials.gov Identifier: NCT00919217     History of Changes
Other Study ID Numbers: 08.0172
Study First Received: June 10, 2009
Last Updated: November 23, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013