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NCT00919217 Clinical Trial

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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:
Exploratory Study on the Timing of MS Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00919217
Other study ID # 08.0172
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2008
Est. completion date December 2024

Study information
Verified date September 2023
Source University of Louisville
Contact Cynthia Corbitt, PhD
Phone 502-852-3915
Email cynthia.corbitt@louisville.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Louisville (recruiting nationwide) Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of days with appearance or worsening of symptoms 3 months
Secondary timing of appearance or worsening of symptoms 3 months
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