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

NCT ID: NCT00919217

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Relapsing-remitting multiple sclerosis

Females with relapsing-remitting multiple sclerosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Corbitt

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia Corbitt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville, Dept. Biology

Locations

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University of Louisville (recruiting nationwide)

Louisville, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cynthia Corbitt, PhD

Role: CONTACT

502-852-3915

Facility Contacts

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Cynthia Corbitt, PhD

Role: primary

502-852-3915

Other Identifiers

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08.0172

Identifier Type: -

Identifier Source: org_study_id

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