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Clinical Trials

Colon Cancer and Oxaliplatin
Elevated Blood Sugar Levels
High Dose Ascorbic Acid Treatment of CMT1A

HIV-Associated Peripheral Neuropathy and EPOETIN ALFA

Colon Cancer and Oxaliplatin

A Natural History of Oxaliplatin Therapy

IRB # 04-06-18-06
Principal Investigator: Michael Polydefkis 410.502.7610

The goal of this collaboration between the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and the Neurology department is to characterize the pattern of nerve injury in people receiving oxaliplatin as part of a chemotherapy regimen to treat colon cancer. As a result of this study, we hope to identify the best technique to detect prevention of oxaliplatin-induced peripheral neuropathy as well as to identify people at risk for oxaliplatin-induced neuropathy.

Key Inclusion Criteria:

1. Informed Consent

2. Diagnosis of colon cancer who are about to start taking oxaliplatin

3. 18-85 years old

Key Exclusion Criteria:

1. Low platelet counts and/or the use of blood thinners other than aspirin
2. Previous neurotoxic exposure

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Elevated Blood Sugar Levels

Longitudinal evaluation of neuropathy in patients with and without glucose dysmetabolism

IRB# 03-11-02-01
Principal Investigator: Michael Polydefkis 410.502.7610

This research is being conducted to better understand the relationship between mildly elevated blood sugar levels and neuropathy, and how the two interact with each other over the course of many years. The study involves peripheral nerve examination including nerve conduction testing and punch skin biopsy on a yearly basis.

Key Inclusion Criteria:

1. Informed consent
2. Impaired glucose tolerance or a recent diagnose of diabetes in the setting of peripheral neuropathy
3. Age between 18 and 80 years

Key Exclusion Criteria:

1. Diagnosed with any of the following conditions:
• Systemic disease other than diabetes that is associated with peripheral neuropathy
• A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy

2. People on blood thinning medications such as coumadin but not aspirin

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High Dose Ascorbic Acid Treatment of CMT1A


Purpose of the Study

The purpose of the study is to evaluate whether high doses of ascorbic acid have any effect on Charcot-Marie-Tooth disease type 1A (CMT1A) and whether or not it should be studied further. Ascorbic acid is also known as vitamin C and has been used and studied extensively for other purposes, but it has never been used to treat CMT1A.

A total of 120 study participants will be enrolled through 3 participating centers: 48 each at Wayne State University (Detroit, MI) and The Johns Hopkins University (Baltimore, MD), and 24 at the University of Rochester (Rochester, NY).

Participant Eligibility

In order to participate in the trial you, or a family member, must meet the following criteria:

1. You, or a family member, must have been genetically tested.*   The result of the genetic test must have been positive for CMT1A. (If you have been tested and are not sure of the results, the contact person at the study center will help you determine whether or not you have CMT1A.)
2. You must be between the ages of 13 and 70.
3. You must not be pregnant.
4. You must be able to make an initial visit to one of the study centers listed above, and you must be able to return to the study center once every six months during the two-year study period *

*Note: Although there is no fee for participation, neither is there any compensation. The study will not pay for genetic testing and participants are responsible for transportation to and from the study centers.

Overview of Study Design

If you decide to participate in this study, you will be asked to take eight (8) study drug- or placebo capsules every day for two years. After an initial evaluation at the research site, you will return every six months for two years to participate in study visits.

This is a double blind, placebo-controlled trial. That means you will be randomly assigned into one of two groups. One group—80 percent of all participants—will receive the ascorbic acid, and the other group—the remaining 20 percent—will receive the placebo. Neither you nor your study doctor will be told which group you are in. At the end of your participation in the study, you will be asked to guess whether you were taking the ascorbic acid or the placebo. At the end of the trial, when all volunteers have completed the study, you will be told which group you were in.

Contact Information

If you meet the criteria outlined above and are interested in participating in this study at the Johns Hopkins Hospital, please contact Ms. Lora Clawson at 410.614.4346.

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HIV-Associated Peripheral Neuropathy and EPOETIN ALFA

IRB#: NA 00001609
Principal Investigator: Dr. Justin McArthur, MBBS, MPH

Patients with HIV-associated neuropathic pain represent a large and growing population. This group remains significantly underserved, however, with no approved therapies and few pharmaceutical clinical trials. Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic. They have relied on pain modifying agents or membrane-stabilizing drugs. This pilot trial aims to explore the efficacy of Epoetin Alfa (EPO) in promoting distal sensory axonal regeneration. As the loss of distal C-fibers in the skin correlates clinically with pain in patients with HIV-sensory neuropathy (as judged by skin biopsy), it is hoped that by promoting cutaneous reinnervation, EPO will reduce neuropathic pain. This hypothesis is supported by studies of EPO in animal models of peripheral neuropathy. EPO is attractive as a neuroprotective/regenerative agent because it has already been clinically used for decades in the chronic treatment of anemia associated with hematological malignancy, renal disease and HIV infection. It is also known to have a good safety profile. Therefore, evaluation of EPO for the treatment of HIV-sensory neuropathy, both DSPN and ATN, is reasonable. This will be a one year multi-center, randomized study to evaluate the effects of two dosing regimens of EPOETIN ALFA (PROCRIT) on distal intra-epidermal nerve fiber density in HIV-associated sensory neuropathies. Other outcome measures will include the Gracely Pain Scale, McGill Pain Questionnaire, Quantitative Sensory Testing (QST), and Global Physician Impression.

Inclusion criteria:

1. Subject is a male or female ? 18 years old.
2. Subject has documented HIV-1 infection.
3. Subject has stable use or nonuse of dideoxynucleoside reverse transcriptase inhibitors (ie. ddI, d4T, ddc) for ?4 months prior to Visit 1.
4. Subject has painful HIV-associated sensory neuropathy (either DSP or ATN), as confirmed by a neurologist.
5. Subject has an average severity of neuropathic pain over the 2 week period between visit 2 and Visit 3 of ?0.74 units measured with the Gracely pain intensity scale.
6. Subject (either male or female) agrees not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and use of contraception as specified in protocol section 3.2.3.
7. Subject or legal guardian/representative agrees to written informed consent.
8. Subject’s hemoglobin is less than 13.0g/dl, but ? 11.0g/dl.

Exclusion criteria:

Neurologic conditions
1. Subject has any condition other than HIV infection or antiretroviral therapy that in the opinion of the site neurologist confounds the diagnosis of neuropathy.
2. Subject has received insulin or oral hypoglycemic products for treatment of diabetes mellitus ?30 days from Visit 1. Dietary control for diabetes will be allowed as long as the diabetes is NOT thought by the site neurologist to be a contributory cause of DSP
3. Subject has a documented history of untreated vitamin B12 deficiency (serum B12 level ?200 pg/mL) or less than 3 months of B12 supplementation other than a multivitamin prior to screening.
4. Subject has hereditary neuropathy.
5. Subject has compression-related neuropathies, i.e. spinal stenosis, that in the opinion of the investigator would preclude analysis of treatment response.
6. Subject has received treatment with any drug other than the dideoxynucleoside analogues that the site neurologist considers to have significantly contributed to the subject’s neuropathy ?30 days from Visit 1.
7. Subject has a history of any alcohol-related medical complications within 6 months of Visit 1 including, but not limited to, alcohol withdrawal seizures, hallucinosis, delirium tremens, or being in a detoxification program.
8. Subject has received neurotoxic chemotherapeutic agents ?90 days from Visit 1.
9. Subject has received neuroregenerative agents ?90 days from Visit 1.
10. Subject has myelopathy that, in the opinion of the site investigator, would interfere with the evaluation of the subject.

Other conditions
11. Subject has uncontrolled hypertension (Systolic Bp>160mmHg and/or Diastolic Bp >100mmHg)
12. Subject has known hypersensitivity to mammalian cell-derived products or albumin.
13. Subject has a history of thrombotic events, including deep venous thrombosis, myocardial infarction, pulmonary embolism and ischemic stroke.
14. Subject has a history of epileptic seizures.
15. Subject has an active AIDS-defining opportunistic infection (OI) or OI-defining condition ?30 days from Visit 1. Subjects who have no evidence of active disease and are receiving maintenance therapy for AIDS-related OIs will be eligible.
16. Subject has active major disease, both HIV-related and non-HIV-related including, but not limited to, cardiac disease, pulmonary, or hepatorenal, which in the opinion of the investigator might affect the study.
17. Subject is pregnant or breast-feeding.
18. Subject has any currently active malignancy.
19. Subject has received any investigational agent(s) that is not FDA-approved or has participated in any interventional research study ?30 days from Visit 1.
20. Subject is actively using recreational intravenous drugs, crack cocaine, or intranasal/smoked heroin or methamphetamine.
21. Subject has chronic renal failure defined for the purposes of this study as a creatinine >1.5 x upper limit of normal (ULN).
22. Subject has hepatitis C and is on interferon/ribavirin therapy.

For questions, or to enroll in this study, please contact Agnes King, 410.502.7611.

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