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Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

NCT00854750 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-04-22

No results posted yet for this study

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).

Conditions

Interventions

DRUG

ACTHAR

SQ weekly injections

DRUG

ACTHAR

SQ weekly injections

DRUG

ACTHAR

SQ weekly injections

DRUG

ACTHAR

SQ weekly injection

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Elliot Frohman

    lead OTHER

Principal Investigators

  • Elliot Frohman, MD, PhD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-05-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00854750 on ClinicalTrials.gov