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

April 12, 2026 updated by: Cynthia Corbitt, University of Louisville

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.

Study Overview

Status

Terminated

Conditions

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

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville (recruiting nationwide)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Relapsing-remitting multiple sclerosis
Females with relapsing-remitting multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of days with appearance or worsening of symptoms
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
timing of appearance or worsening of symptoms
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Cynthia Corbitt, PhD, University of Louisville, Dept. Biology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2008

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimated)

June 12, 2009

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.0172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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