Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03000127
Other study ID # 1R01NS102295
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date January 1, 2024

Study information

Verified date November 2019
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2024
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AndroGel 1 % Topical Gel
testosterone gel
Placebos
Placebo gel

Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California
United States Washington University Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (11)

Dalal M, Kim S, Voskuhl RR. Testosterone therapy ameliorates experimental autoimmune encephalomyelitis and induces a T helper 2 bias in the autoantigen-specific T lymphocyte response. J Immunol. 1997 Jul 1;159(1):3-6. — View Citation

Gold SM, Chalifoux S, Giesser BS, Voskuhl RR. Immune modulation and increased neurotrophic factor production in multiple sclerosis patients treated with testosterone. J Neuroinflammation. 2008 Jul 31;5:32. doi: 10.1186/1742-2094-5-32. — View Citation

Gold SM, Voskuhl RR. Estrogen and testosterone therapies in multiple sclerosis. Prog Brain Res. 2009;175:239-51. doi: 10.1016/S0079-6123(09)17516-7. Review. — View Citation

Golden LC, Voskuhl R. The importance of studying sex differences in disease: The example of multiple sclerosis. J Neurosci Res. 2017 Jan 2;95(1-2):633-643. doi: 10.1002/jnr.23955. Review. — View Citation

Hussain R, Ghoumari AM, Bielecki B, Steibel J, Boehm N, Liere P, Macklin WB, Kumar N, Habert R, Mhaouty-Kodja S, Tronche F, Sitruk-Ware R, Schumacher M, Ghandour MS. The neural androgen receptor: a therapeutic target for myelin repair in chronic demyelination. Brain. 2013 Jan;136(Pt 1):132-46. doi: 10.1093/brain/aws284. — View Citation

Kurth F, Luders E, Sicotte NL, Gaser C, Giesser BS, Swerdloff RS, Montag MJ, Voskuhl RR, Mackenzie-Graham A. Neuroprotective effects of testosterone treatment in men with multiple sclerosis. Neuroimage Clin. 2014 Mar 6;4:454-60. doi: 10.1016/j.nicl.2014.03.001. eCollection 2014. — View Citation

Liva SM, Voskuhl RR. Testosterone acts directly on CD4+ T lymphocytes to increase IL-10 production. J Immunol. 2001 Aug 15;167(4):2060-7. — View Citation

Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. — View Citation

Spence RD, Voskuhl RR. Neuroprotective effects of estrogens and androgens in CNS inflammation and neurodegeneration. Front Neuroendocrinol. 2012 Jan;33(1):105-15. doi: 10.1016/j.yfrne.2011.12.001. Epub 2011 Dec 24. Review. — View Citation

Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012 Mar 27;8(5):255-63. doi: 10.1038/nrneurol.2012.43. Review. — View Citation

Ziehn MO, Avedisian AA, Dervin SM, Umeda EA, O'Dell TJ, Voskuhl RR. Therapeutic testosterone administration preserves excitatory synaptic transmission in the hippocampus during autoimmune demyelinating disease. J Neurosci. 2012 Sep 5;32(36):12312-24. doi: 10.1523/JNEUROSCI.2796-12.2012. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Correlation of testosterone level with fatigue 18 months
Other Correlation of localized gray matter atrophy with fatigue 18 months
Other Correlation of axon density in white matter with fatigue 18 months
Primary Modified Fatigue Impact Scale (MFIS) assessment of fatigue severity 18 months
Secondary Localized Gray Matter Atrophy Quantify effect of testosterone treatment on localized gray matter atrophy 18 months
Secondary Axon Density in White Matter Quantify effect of testosterone treatment on axon density in major white matter tracts 18 months
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis