Status:
TERMINATED
Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis
Lead Sponsor:
Elliot Frohman
Collaborating Sponsors:
Mallinckrodt
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The investigators principal hypothesis is that INO and optic neuritis are objective, quantitative, and reproducible models for corroborating the hypothesis that changes in core body temperature are as...
Detailed Description
A quantum leap forward in our understanding of MS pathophysiology was provided by the discovery of myelin by Louis Ranvier in 1878, and by Pierre Marie who first suggested in 1892 that demyelination r...
Eligibility Criteria
Inclusion
- Subject has clinically or laboratory supported Multiple Sclerosis with evidence of INO by quantitative neurophysiologic criteria or has a history of ON.
- Subject is between the ages of 18-65.
- Subject is able to understand the demands of the protocol, has had any questions answered and has voluntarily signed the informed consent prior to any study procedures.
- Subject has a peak saccadic acceleration ratio (abducting eye/adducting eye) of greater than 2S.D. above the mean derived form a normal control group.
- Subject is otherwise in good health, based on complete medical history and physical examination, including vital signs and ECG.
Exclusion
- Subject is a pregnant female (as determined by a urine pregnancy test), a lactating female, or a female of child-bearing potential, not sterilized and not using one of the following methods of birth control: oral or injectable contraceptive agent, implantable contraceptive device, or barrier method.
- Subject has a history of hypertension or diabetes.
- Subject has known allergy to ACTH.
- The subject has any medical condition, including psychiatric disease that might interfere with the interpretation of the results or with the conduct of the study.
- Subject has a history of drug or ethanol abuse within the past year.
- Subject has a history of ischemic heart disease.
- Subject has received an investigational drug within 30 days of screening.
- In opinion of investigator, subject is unlikely to complete study for any reason.
- The subject has abnormal clinical laboratory values or an abnormal ECG, without approval of the study monitor.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00854750
Start Date
May 1 2009
End Date
July 1 2010
Last Update
April 22 2013
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390