Exploratory Study on the Timing of Multiple Sclerosis (MS) Symptoms
Recruitment status was Recruiting
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| First Received Date ICMJE | June 10, 2009 | ||||||||
| Last Updated Date | November 23, 2010 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
number of days with appearance or worsening of symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00919217 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
timing of appearance or worsening of symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Exploratory Study on the Timing of Multiple Sclerosis (MS) Symptoms | ||||||||
| Official Title ICMJE | Exploratory Study on the Timing of MS Symptoms | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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 |
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| Condition ICMJE | Relapsing Remitting Multiple Sclerosis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Relapsing-remitting multiple sclerosis
Females with relapsing-remitting multiple sclerosis |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00919217 | ||||||||
| Other Study ID Numbers ICMJE | 08.0172 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Cynthia Corbitt, PhD, University of Louisville, Department of Biology | ||||||||
| Study Sponsor ICMJE | University of Louisville | ||||||||
| Collaborators ICMJE | Bayer | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Louisville | ||||||||
| Verification Date | November 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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