Relapsing Remitting Multiple SclerosisNCT00919217
Exploratory Study on the Timing of Multiple Sclerosis (MS) Symptoms
An observational study of Relapsing Remitting Multiple Sclerosis, run by University of Louisville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- females
- diagnosed with relapsing-remitting multiple sclerosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville (recruiting nationwide)
Louisville, Kentucky, 40292
About this study
Official title: Exploratory Study on the Timing of MS Symptoms
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.
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Relapsing-remitting multiple sclerosis, RR-MS, Women
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Relapsing-remitting multiple sclerosis | Females with relapsing-remitting multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days with appearance or worsening of symptoms
Measured: 3 months
Secondary outcomes (1)
timing of appearance or worsening of symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2025
- Study completionMay 2025
Why it stopped: Not enough subjects have been recruited over an extended period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Corbitt, University of Louisville
- Investigators
- Cynthia Corbitt, PhD, Principal investigator, University of Louisville, Dept. Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919217
- Sponsor's protocol ID
- 08.0172
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2009
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Timing of MS Symptoms
- ClinicalTrials.gov ID
- NCT00919217
- Acronym / sponsor ID
- 08.0172
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Relapsing-remitting multiple sclerosis, RR-MS, Women
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough subjects have been recruited over an extended period.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- May 2025 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing-remitting multiple sclerosis | – | –Females with relapsing-remitting multiple sclerosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- females
- diagnosed with relapsing-remitting multiple sclerosis
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of days with appearance or worsening of symptoms
Time frame: 3 months
1 secondary outcome
timing of appearance or worsening of symptoms
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Not enough subjects have been recruited over an extended period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Corbitt, PhD principal investigator
University of Louisville, Dept. Biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough subjects have been recruited over an extended period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of days with appearance or worsening of symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.