Multiple SclerosisNCT00229502
Cognitive Effects of Immunomodulatory Drugs in MS
An observational study of Multiple Sclerosis, run by Sharon Lynch, MD at 1 site in United States.
Trial summary
The purpose of this study is to examine and compare changes in the specific thinking skills of patients with RRMS who are receiving treatment with one of three immunomodulatory medications (Avonex, Copaxone, or Rebif). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Multiple sclerosis clinic
Who may be able to join
- Diagnosis of RRMS for at least one year,
- Currently on one of three immunomodulatory drugs (Avonex, Copaxone, or Rebif),
- Visual Acuity is 20/50 or better,
- patient has four color vision,
- Must have at least a high school education
Who cannot join
- History of head injury, drug/alcohol abuse, and/or psychiatric problems, -current diagnosis of a severe or lifethreatening disease other than MS,
- currently taking immunosuppressant medication,
- resides greater than 200 miles from the study site
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Comparison of the Cognitive Effects of Three Immunomodulatory Drugs in Relapsing-Remitting Multiple Sclerosis: A Longitudinal Study
The purpose of this study is to examine and compare changes in the specific thinking skills of patients with RRMS who are receiving treatment with one of three immunomodulatory medications (Avonex, Copaxone, or Rebif).
Read the detailed description
In addition this study will compare the patients' personal view of how they are doing, any changes in physical disability, and the frequency and severity of relapses over the three year period.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- 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 |
|---|---|---|
| 1 | Subjects receiving Avonex | |
| 2 | Subjects receiving Rebif | |
| 3 | Subjects receiving Copaxone | |
| 4 | Healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Lynch, MD
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Sponsor-investigator, Sharon Lynch, MD, University of Kansas Medical Center
- Investigators
- Sharon G Lynch, MD, Principal investigator, University of Kansas Medical CenterDouglas R Denney, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229502
- Sponsor's protocol ID
- 10066
- Status last verified
- Mar 2012
- First submitted
- 27 Sep 2005
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Cognitive Effects of Three Immunomodulatory Drugs in Relapsing-Remitting Multiple Sclerosis: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT00229502
- Acronym / sponsor ID
- 10066
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sharon Lynch, MDUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- Sep 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Sep 2005 (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 purpose of this study is to examine and compare changes in the specific thinking skills of patients with RRMS who are receiving treatment with one of three immunomodulatory medications (Avonex, Copaxone, or Rebif).
Detailed description
In addition this study will compare the patients' personal view of how they are doing, any changes in physical disability, and the frequency and severity of relapses over the three year period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects receiving Avonex |
| 2 | – | –Subjects receiving Rebif |
| 3 | – | –Subjects receiving Copaxone |
| 4 | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Multiple sclerosis clinic
Key inclusion criteria (5 listed)
- Diagnosis of RRMS for at least one year,
- Currently on one of three immunomodulatory drugs (Avonex, Copaxone, or Rebif),
- Visual Acuity is 20/50 or better,
- patient has four color vision,
- Must have at least a high school education
Key exclusion criteria (3 listed)
- History of head injury, drug/alcohol abuse, and/or psychiatric problems, -current diagnosis of a severe or lifethreatening disease other than MS,
- currently taking immunosuppressant medication,
- resides greater than 200 miles from the study site
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
Sharon G Lynch, MD principal investigator
University of Kansas Medical Center
Douglas R Denney, PhD principal investigator
University of Kansas Medical Center
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 Multiple Sclerosis, run by Sharon Lynch, MD 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 23 Mar 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 23 Mar 2012.