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WST-057 for Neuropathy

Phase 2
Waitlist Available
Research Sponsored by WinSanTor, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test a new topical cream to see if it is safe and effective at treating HIV-related nerve pain.

Eligible Conditions
  • HIV-associated Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
+1 more
Secondary outcome measures
IENFD change from baseline for both treated and untreated skin
Medical Outcomes Study HIV Health Survey (MOS-HIV)
Neuropathic Pain Scale-10 (NPS-10)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: WST-057Experimental Treatment1 Intervention
WST-057 topical solution
Group II: PlaceboPlacebo Group2 Interventions
WST-057 Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WST-057
2022
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

WinSanTor, IncLead Sponsor
3 Previous Clinical Trials
176 Total Patients Enrolled
Angela HansenStudy DirectorWinSanTor, Inc
3 Previous Clinical Trials
176 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this clinical experiment still feasible for potential subjects?

"Yes, according to clinicaltrials.gov this trial has been open since February 24th 2022 and is actively in search of participants. A total of 60 people are being recruited from 3 separate sites."

Answered by AI

How many individuals are presently participating in this clinical experiment?

"Confirmed. According to the information posted on clinicaltrials.gov, this research endeavour, first announced in February of 2022 and recently updated in November, is actively recruiting participants from 3 medical facilities for a total of 60 patients."

Answered by AI

What criteria must individuals meet in order to enroll in this trial?

"This clinical trial seeks 60 participants aged between 18 and 80 who are suffering from polyneuropathy. Eligible persons must be male or female, with females of childbearing age requiring either no access to contraception (due to menopause) or a highly effective medically acceptable method such as hormonal contraceptives, intrauterine devices/systems, vasectomy (in the partner), or an approved combination of barrier methods like condoms. Additionally all subjects need to attend the required study visits on schedule."

Answered by AI

What specific goals is this inquiry attempting to accomplish?

"This clinical trial will be assessing the incidence of Treatment Emergent Adverse Events over a 16-week period as judged by vital signs such as blood pressure, heart rate, and respiratory rate. Secondary outcomes include Patient's Global Impression of Change (PGIC), Medical Outcomes Study HIV Health Survey (MOS-HIV) and Neuropathy Total Symptom Score-6 (NTSS-6). PGIC is evaluated with a 7 point scale measuring "much improved" to "much worse," whereas MOS-HIV encompasses 35 items related to health perceptions, pain management etc., scored on a 0 - 100 scale;"

Answered by AI

Is there a minimum age requirement to participate in this experiment?

"According to the eligibility requirements of this clinical trial, prospective participants must be between 18 and 80 years old."

Answered by AI

Has WST-057 received regulatory authorization from the FDA?

"The therapeutic agent WST-057 was rated a 2 on our safety index, as it is currently in phase 2 trials and there is only preliminary evidence indicating its safety."

Answered by AI

Who else is applying?

What state do they live in?
Vermont
How old are they?
18 - 65
What site did they apply to?
HNRP - Theodore Gildred Facility
Palmtree Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Most responsive sites:
  1. HNRP - Theodore Gildred Facility: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
~5 spots leftby Apr 2025