Multiple Sclerosis
Conditions
Keywords
testosterone, multiple sclerosis, fatigue
Brief summary
Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are limited. Several studies have shown that a large proportion of men with MS have low testosterone levels. We propose a two-site clinical trial using topical testosterone gel as a treatment for MS-related fatigue in men with progressive MS who have low or low-normal testosterone levels.
Interventions
DRUGAndroGel 1 % Topical Gel
testosterone gel
DRUGPlacebos
Placebo gel
Sponsors
Washington University School of Medicine
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
All patients will receive either testosterone or placebo at some phase of treatment, but which phase will be testosterone and which will be placebo will be unknown (blinded) to participant, care provider, and outcomes assessor.
Intervention model description
Single arm, testosterone or placebo will be administered to all patients at some period of study, but which period of study the they will recieve placebo or testosterone gel will be blinded (unknown) to participant, care provider, and outcomes assessor.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1\) Men with SPMS or PPMS, 2)18-60 years old, 3) EDSS of 1.0- 6.5, 4) Low or low-normal T \< 499ng/dL and 5) FSS scores of \>3.6.
Exclusion criteria
1\) Prostate specific antigen \> 2.5 (\<49yr of age) or \>3.5 (age \>50yr of age), 2) baseline hematocrit greater than the upper limit of normal for the laboratory used, 3) EKG with ischemic changes, 4) history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis, 5) history of prostate or breast cancer, 6) screening T level \>500ng/dL, 7) diabetes requiring treatment, 8) current drug/alcohol abuse, 9) disease other than MS causing fatigue, such as obstructive sleep apnea or other sleep disorder, or untreated thyroid dysfunction, 10) RRMS, 11) Beck Depression Inventory-II (BDI) score over 20, 12) cognitive dysfunction such that subject cannot perform study tests, 13) inability to undergo MRI, 14) current or expected use of amphetamines, or 15) anticipated changes in medical treatments that might affect fatigue scores (e.g., expected changes in spasticity, sleep, or depression medications).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Fatigue Impact Scale (MFIS) | 18 months | assessment of fatigue severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Localized Gray Matter Atrophy | 18 months | Quantify effect of testosterone treatment on localized gray matter atrophy |
| Axon Density in White Matter | 18 months | Quantify effect of testosterone treatment on axon density in major white matter tracts |
Other
| Measure | Time frame |
|---|---|
| Correlation of testosterone level with fatigue | 18 months |
| Correlation of localized gray matter atrophy with fatigue | 18 months |
| Correlation of axon density in white matter with fatigue | 18 months |
Countries
United States
Outcome results
None listed