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Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

This study has been terminated.
(Poor Enrollment- schedule of assessments too complex and time-consuming.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00854750
First Posted: March 3, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Elliot Frohman, University of Texas Southwestern Medical Center
  Purpose
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).

Condition Intervention Phase
Multiple Sclerosis Drug: ACTHAR Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Elliot Frohman, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To determine if preemptive cooling provides protection against worsening of INO and its effect on reading, with body heating. [ Time Frame: 8-10 weeks for each patient ]

Secondary Outcome Measures:
  • To determine whether changes in core body temperature has an impact on patient reported measures of vision (high and low contrast acuity) and reading acuity and speed. [ Time Frame: 8-10 weeks per patient ]

Enrollment: 1
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACTHAR- placebo first
Placebo, 20 mg, 40 mg, 80 mg
Drug: ACTHAR
SQ weekly injections
Experimental: ACTHAR- placebo second
20mg, Placebo, 40 mg, 80mg
Drug: ACTHAR
SQ weekly injections
Experimental: ACTHAR- placebo third
20 mg, 40 mg, Placebo, 80 mg
Drug: ACTHAR
SQ weekly injections
Experimental: ACTHAR- placebo fourth
20 mg, 40 mg, 80 mg, Placebo
Drug: ACTHAR
SQ weekly injection

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854750


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Elliot Frohman
Mallinckrodt
Investigators
Principal Investigator: Elliot Frohman, MD, PhD UT Southwestern Medical Center
  More Information

Responsible Party: Elliot Frohman, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00854750     History of Changes
Other Study ID Numbers: ACTHAR version 1.0
First Submitted: February 27, 2009
First Posted: March 3, 2009
Last Update Posted: October 12, 2017
Last Verified: April 2013

Keywords provided by Elliot Frohman, University of Texas Southwestern Medical Center:
Multiple Sclerosis, hx of unilateral ON, evidence of thermal sensitivity, and no evidence of an ocular motor syndrome
Multiple Sclerosis, no evidence of ON, and evidence of thermal sensitivity
Healthy age/gender matched controls

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Demyelinating Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs