Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin) for multiple sclerosis.

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).

It had four arms (groups): ACTHAR- placebo first (experimental), ACTHAR- placebo second (experimental), ACTHAR- placebo third (experimental) and ACTHAR- placebo fourth (experimental).

The registry classes the interventions as drug.

More on the Plan

Understanding this conspicuous aspect of MS pathophysiology allows them to predict many of the reversible symptoms described by their patients, particularly those that are provoked or intensified by elevated ambient or core body temperature, exercise, and infection.

Such processes appear to compromise the safety threshold for high fidelity nerve transmissions.

In essence, these frequent, transient, typically stereotypic and reversible physiologic changes constitute a major component of MS related disability.

Such symptoms include fatigue, weakness, gait dysfunction, spasticity, heat intolerance, pain, cognitive changes, sensory disturbances, bowel, bladder, sexual dysfunction, depression, and hopelessness.8 While the underpinnings of these complaints are manifold, changes in axonal conduction mechanisms now represent a well-recognized and cardinal feature of MS pathophysiology.

Who Took Part

1 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

As a double-blind ACTH (Corticotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-05 with completion listed for 2010-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 1 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, Multiple sclerosis research.