Modeling and Treating the Pathophysiology of Demyelination in Multiple
Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Poor Enrollment- schedule of assessments too complex and time-consuming.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Corticotropin
Melanocortin receptor 2 agonist
What it measured
Main measures
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
Other measures (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
VisionQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 65
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
Related trials
- Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocogn
Status unknown
Paper found, not read
- Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activit
Phase 4 · Stopped early
Stopped
- Effect of Corticosteroids on Inflammation at the Edge of Acute Multipl
Phase 2 · Recruiting
Still running
- Evaluation of the Response to Acthar Gel Therapy in Patients Who Faile
Not a drug-phase study · Status unknown
No results found
- A Trial of Neuroprotection With ACTH in Acute Optic Neuritis
Phase 4 · Stopped early
Stopped
- GSK239512 DDI Study
Phase 1 · Completed
No results found
History
Started
May 2009
Main results due
May 2010
Finished
Jul 2010