Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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 associated with the reversible and stereotypic decay in axonal conduction and that ACTHAR can serve to prevent such changes. The application of ocular motor and optic nerve measures appears to constitute a useful paradigm to detect and monitor responses to therapeutic strategies that stabilize nerve cell membranes in response to temperature induced decay in axonal conduction mechanisms, with implications on activities of daily life that are dependent upon vision (reading, driving, walking, work performance).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Elliot Frohman
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

1. Subject has clinically or laboratory supported Multiple Sclerosis with evidence of INO by quantitative neurophysiologic criteria or has a history of ON.

2. Subject is between the ages of 18-65.

3. 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.

4. 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.

5. Subject is otherwise in good health, based on complete medical history and physical examination, including vital signs and ECG.

Exclusion Criteria:

1. 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.

2. Subject has a history of hypertension or diabetes.

3. Subject has known allergy to ACTH.

4. 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.

5. Subject has a history of drug or ethanol abuse within the past year.

6. Subject has a history of ischemic heart disease.

7. Subject has received an investigational drug within 30 days of screening.

8. In opinion of investigator, subject is unlikely to complete study for any reason.

9. The subject has abnormal clinical laboratory values or an abnormal ECG, without approval of the study monitor.