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

Exploratory Study on the Timing of MS Symptoms

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00919217

Enrollment

Registered

2009-06-12

Start date

2008-08-01

Completion date

2025-05-01

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis, MS, Relapsing-remitting multiple sclerosis, RR-MS, Women

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of days with appearance or worsening of symptoms	3 months

Secondary

Measure	Time frame
timing of appearance or worsening of symptoms	3 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCynthia Corbitt, PhD

University of Louisville, Dept. Biology

Outcome results