WST-057 for Polyneuropathies

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
HNRP - Theodore Gildred Facility, San Diego, CA
Polyneuropathies+1 More
WST-057 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a topical cream can improve sensory symptoms in people with HIV.

See full description

Eligible Conditions

  • Polyneuropathies
  • HIV Associated Polyneuropathy

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether WST-057 will improve 4 primary outcomes and 8 secondary outcomes in patients with Polyneuropathies. Measurement will happen over the course of 16 weeks.

16 weeks
IENFD change from baseline for both treated and untreated skin
Incidence of Treatment Emergent Adverse Events as assessed by ECG (measuring p wave, QRS complex, QT interval)
Incidence of Treatment Emergent Adverse Events as assessed by dermal assessment (Draize score 0.0-4.0) score of skin erythema, edema pruritus and dryness score) of the dosing area
Incidence of Treatment Emergent Adverse Events as assessed by hematology and clinical pathology blood tests
Incidence of Treatment Emergent Adverse Events as assessed by vital signs (blood pressure (diastolic and systolic mmHg), heart rate (beats per minute), respiratory rate (breaths per minute).
Medical Outcomes Study HIV Health Survey (MOS-HIV)
Neuropathic Pain Scale-10 (NPS-10)
Neuropathy Total Symptom Score-6 (NTSS-6)
Patient's Global Impression of Change (PGIC)
Quantitative Sensory Testing (QST)
Utah Early Neuropathy Score (UENS)
Visual Analogues Score (VAS) for pain assessment

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

WST-057 active
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. WST-057 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

WST-057 active
Drug
WST-057 topical solution
Placebo
Drug
WST-057 Matching placebo

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 16 weeks for reporting.

Closest Location

HNRP - Theodore Gildred Facility - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients aged 18 to 80 (inclusive), both male and female. show original
or two abnormal results on nerve conduction studies (either reproducible sensory abnormalities or prolonged distal motor latency) show original
The person had pain or discomfort on their lower extremities that was greater than 20 mm but less than 80 mm on a scale of 0 mm to 100 mm show original
Participants must provide written informed consent prior to participating in the study or undergoing any study procedures. show original
The person has an HIV infection that has been confirmed by serologic testing and the person is currently virally suppressed on ART. show original
Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and must be practicing a highly effective medically acceptable method of contraception, including abstinence; hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; or vasectomy (partner), for at least 1 month before the screening visit and for 1 month after the end of the last dose of study drug. If access or use of a highly effective medically acceptable method of contraception is not achievable, then a combination of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge) is acceptable. Eligible female subjects must also have a negative serum beta-human chorionic gonadotropin at the screening visit.
The average ankle IENF density for someone in this population is below the 5%ile, based on Lauria norms that have been adjusted for age and sex. show original
If you have diabetes, your glycemic control should be stable for at least three months before you're randomized show original
Return for study visits on the required dates
Males must use one of the acceptable forms of contraception listed above. show original

Patient Q&A Section

What are common treatments for polyneuropathies?

"Peripheral neuropathies are often treated with medications, such as anticonvulsants, bisphosphonates, and antiepileptics, or with physical therapy. When medication proves ineffective, tranexamic acid can be a valuable alternative. In the case that an antitoxin for botulinum toxin therapy is unavailable, a trial of botulinum toxin A (Botox) is effective. Botulinum toxin A is usually injected by muscle biopsy. When Botox is not an option, surgery often is needed to excise the nerve. Nerve blocks are also one of several options. If a surgery is required, peripheral nerve blockade is sometimes used." - Anonymous Online Contributor

Unverified Answer

How many people get polyneuropathies a year in the United States?

"About 3.8 million Americans have at least one polyneuropathy. Most polyneuropathies can be explained with either peripheral neuropathy, Guillain-Barré syndrome, tabes dorsalis, or a combination of them." - Anonymous Online Contributor

Unverified Answer

What causes polyneuropathies?

"Polyneuropathy can be caused by traumatic injuries and/or medical conditions such as diabetes mellitus, alcoholism, and certain types of cancer. It can also be a symptom of illnesses such as SLE, AIDS, and infectious diseases. To find active epilepsy clinical trials in your area, you can use Power. The condition often affects adults in their late 30s and 40s, but the onset is often delayed. People with polyneuropathy are often hesitant about seeking help because they do not know where to start. To find active polyneuropathy clinical trials in your area, use [Power](http://www.withpower." - Anonymous Online Contributor

Unverified Answer

Can polyneuropathies be cured?

"The evidence that axonal polyneuropathy is not easily cured led to reconsideration of the definition of 'cure' of polyneuropathy. This has led to the conclusion that all forms of polyneuropathy can be cured in some patients but that recovery of sensory and autonomic function from polyneuropathy is dependent on the type of polyneuropathy and the nature of the treatment. Such findings warrant consideration of the value of new treatments." - Anonymous Online Contributor

Unverified Answer

What are the signs of polyneuropathies?

"The clinical suspicion of polyneuropathy can be determined by the signs and symptoms, and can be more accurately interpreted with testing. The most helpful parameter for the diagnosis of sensory polyneuropathies is needle electromyography which can help to distinguish between critical polyneuropathy and polyneuropathy. In severe sensory polyneuropathies the diagnosis may be confirmed by electrodiagnostic studies." - Anonymous Online Contributor

Unverified Answer

What is polyneuropathies?

"For the most part, the most frequent clinical features were sensory and motor disturbances, autonomic disturbances and gastrointestinal disturbances, often presenting with some degree of neuropathy, with or without neurologic signs. However, polyneuropathies can vary in the distribution and clinical manifestations, depending on the type of polyneuropathy and the severity of the disease." - Anonymous Online Contributor

Unverified Answer

Does wst-057 improve quality of life for those with polyneuropathies?

"Wst-057 significantly improved the quality of life of people with peripheral neuropathy. Data from a recent study provide the first evidence demonstrating that a pharmacological agent can contribute to improved quality of life. This is relevant given the growing interest in using novel therapeutics to delay the progression of disabling conditions." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for polyneuropathies?

"The presence or absence of polyneuropathy should not influence the decision to participate in a study of potential therapeutic benefit to patients with multiple sclerosis." - Anonymous Online Contributor

Unverified Answer

Is wst-057 typically used in combination with any other treatments?

"These study results suggested that there was not a clinically important benefit for using a dual agent regimen containing Wst-057 and other drugs, with the possible exception of the use of such agents in patients with polyneuropathy." - Anonymous Online Contributor

Unverified Answer

How does wst-057 work?

"wst-057 has therapeutic benefit in a number of preclinical models, including models of amyotrophic lateral sclerosis, stroke, and stroke recovery. The preclinical data support further clinical investigation of wst-057 in multiple sclerosis and ALS." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets polyneuropathies?

"The average disease age is 57 years. Results from a recent clinical trial could not be powered for exact quantifications, but it does show a trend of earlier onset in patients with diabetes. Furthermore, the rate of progression decreases with age. There does not appear to be an association between polyneuropathy and smoking, alcoholism, diabetes, or duration of disease. More studies are needed to determine whether polyneuropathy does worsen with age and whether this relationship is due to polyneuropathy or to the development of diabetes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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