Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

NCT00854750 | Terminated Phase 4 DMC

• 1 other identifier: ACTHAR version 1.0
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To determine if preemptive cooling provides protection against worsening of INO and its effect on reading, with body heating.

  8-10 weeks for each patient

Secondary Outcomes (1)

• 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.

  8-10 weeks per patient

Study Arms (4)

ACTHAR- placebo first

EXPERIMENTAL

Placebo, 20 mg, 40 mg, 80 mg

Drug: ACTHAR

ACTHAR- placebo second

EXPERIMENTAL

20mg, Placebo, 40 mg, 80mg

Drug: ACTHAR

ACTHAR- placebo third

EXPERIMENTAL

20 mg, 40 mg, Placebo, 80 mg

Drug: ACTHAR

ACTHAR- placebo fourth

EXPERIMENTAL

20 mg, 40 mg, 80 mg, Placebo

Drug: ACTHAR

Interventions

ACTHAR DRUG

SQ weekly injections

ACTHAR- placebo first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elliot Frohman: lead
• Mallinckrodt: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Elliot Frohman, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 3, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

US (1)