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

Recruiting

• Conditions: Relapsing Remitting Multiple Sclerosis

• Registration Number: NCT00919217
• Lead Sponsor: University of Louisville

Brief 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.

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of days with appearance or worsening of symptoms	3 months

Secondary Outcome Measures

Name	Time	Method
timing of appearance or worsening of symptoms	3 months

Trial Locations

Locations (1)

University of Louisville (recruiting nationwide); 🇺🇸 Louisville, Kentucky, United States