CLINICAL TRIAL

Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution for Peripheral Nervous System Diseases

Waitlist Available · 18+ · All Sexes · Norfolk, VA

This study is evaluating whether a drug may help improve pain for individuals with diabetes.

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About the trial for Peripheral Nervous System Diseases

Eligible Conditions
Pain · Diabetic Neuropathies · Diabetic Neuropathy, Painful; Diabetic Neuropathies · Peripheral Nervous System Diseases · Diabetes Mellitus

Treatment Groups

This trial involves 2 different treatments. Active: WST-057 4mL (146 Mg Pirenzepine Free Base Monohydrate) Topical Solution 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution
DRUG

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Men must use a contraceptive that is accepted by both of us, such as a condom with a diaphragm, a condom with a cervical cap, or a condom with spermicide. show original
Be able to report accurately and reliably symptoms, including treatment-emergent signs and symptoms. show original
The individual has had diabetic neuropathy for at least 12 months that has affected their lower extremities. show original
Please sign this form to indicate that you have read and understand the consent form, and that you agree to participate in the study. 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 study. 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.
Return for study visits on the required dates
The individual must be able to physically inspect calves, tops of ankles, and soles of feet for wounds, infections, or other anomalies show original
The patient had a pain score of over 30 mm on their lower extremities within the last 24 hours. show original
The diagnosis of T2DM is based on a patient's symptoms and medical history, as well as on the results of a physical examination show original
Patients aged between 30 and 75 years old (both male and female). show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 weeks.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution will improve 4 primary outcomes, 3 secondary outcomes, and 2 other outcomes in patients with Peripheral Nervous System Diseases. Measurement will happen over the course of 12 weeks.

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
12 WEEKS
Safety will be assessed by observing changes in patients' blood tests when compared to normal lab values/ranges after once daily dosing of 1 dose level of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAEv4.0 will be reported.
12 WEEKS
Norfolk Quality of Life for Diabetic Peripheral Neuropathy -Physical Large Fiber Function Subset Score
12 WEEKS
The Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) tool is a validated, 35-item, self-administered questionnaire that measures the relationship between symptoms of diabetic neuropathy and Quality of Life (QoL). It is subdivided in 5 domains that include measures of somatic nerve function (small and large fibers), symptoms, autonomic nerve function and activities of daily living (ADLs)
12 WEEKS
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).
12 WEEKS
Safety will be assessed by observing changes in patients' blood tests when compared to normal lab values/ranges after once daily dosing of 1 dose level of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAEv4.0 will be reported.
12 WEEKS
Incidence of Treatment Emergent Adverse Events as assessed by ECG (measuring p wave, QRS complex, QT interval)
12 WEEKS
Safety will be assessed by observing changes in patients' blood tests when compared to normal lab values/ranges after once daily dosing of 1 dose level of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAEv4.0 will be reported.
12 WEEKS
Intraepidermal Nerve Fiber Density (IENFD) of the dosing area
12 WEEKS
Skin Biopsies and quantification of IENF density (IENFD): This measurement will provide the other co-secondary outcome measures for the study so that effects on both patient function and nerve structure are assessed. IENFD is the gold standard for measuring small fiber neuropathy
12 WEEKS
Incidence of Treatment Emergent Adverse Events as assessed by hematology and clinical pathology blood tests
12 WEEKS
Safety will be assessed by observing changes in patients' blood tests when compared to normal lab values/ranges after once daily dosing of 1 dose level of WST-057 solution or placebo. The number of participants with treatment-related adverse events as assessed by CTCAEv4.0 will be reported.
12 WEEKS
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Patient Q & A Section

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

What are common treatments for peripheral nervous system diseases?

The treatment for PNSD was mainly conservative in nature. The mainstay of treatment for PNSD, in patients who present with lower limb weakness, is physiotherapy. In the case of muscle atrophy or limb loss, the mainstay of treatment was to place an immobilizer or an orthosis. Although no randomized trial was performed to assess the effectiveness and safety, evidence from many case series suggested that the combination therapy of botulinum toxin and oral rehabilitation is a viable option in treating spastic paraplegic patients suffering from spastic quadriplegia or spastic paraparesis. Elective surgery remained only as a second-line treatment option when the diagnosis was clear.

Anonymous Patient Answer

Can peripheral nervous system diseases be cured?

There is still poor knowledge of how peripheral nervous system diseases are created and how to prevent and treat them, and how to detect and diagnose diseases more easily. We can increase our knowledge and use more efficient treatments if we can use modern medical treatment as well as physical therapies to treat peripheral nervous system diseases. Thus, in order to cure peripheral nervous system diseases by using treatment, we should use different types and modes of treatments such as diet, pharmacological intervention or surgery.

Anonymous Patient Answer

How many people get peripheral nervous system diseases a year in the United States?

For most of the common peripheral nervous system diseases, more than one person per year in the United States suffers the disorder. The percentage of cases of polyneuritis and mononeuritis seems to decline with age and to be more common in men than women. The overall percentage of polyneuritis cases seem to be influenced by geographic distribution as well as by age.

Anonymous Patient Answer

What causes peripheral nervous system diseases?

The causes of peripheral nervous system disorders are varied and can include hereditary conditions, injuries and poisonings while work is the leading cause of PNS disorder. PNS diseases can be divided into specific categories including neurological disorders, vascular, endocrine, hematological & infectious disorders (Fisher's syndrome). There is also an associated association between specific illnesses and PNS disorders, such as diabetes and multiple sclerosis. Clinicians should have a heightened vigilance for detecting PNS disorders and consider the clinical scenario for each patient.

Anonymous Patient Answer

What is peripheral nervous system diseases?

The nervous system forms a major part of the total organism and plays an important role in most biological processes. PNS can be injured through disease and disease-causing agents. PNS disease is often a disease with a poor prognosis. A better understanding of the pathogenesis of PNS diseases is critical for developing appropriate therapy and optimizing the outcome.

Anonymous Patient Answer

What are the signs of peripheral nervous system diseases?

The most common signs of peripheral nervous system diseases are sensory and sensoromotor neuropathy signs. They are pain of radicular nature and numbness, weakness, and other sensory complaints. Muscle atrophy, wasting, and fasciculation may mimic the symptoms of the peripheral neuropathy, or muscle abnormalities may mimic the signs of a neuromuscular disease. In addition to the above-mentioned symptoms, some autonomic neuropathies may cause a generalized sympathetic symptomatology related to the sympathetic trunk or autonomic nerves. Muscle weakness, wasting, and fasciculation may be similar to that of peripheral neuropathy. However, the wasting, fasciculation, and wasting signs are caused by autonomic neuropathies.

Anonymous Patient Answer

What is the latest research for peripheral nervous system diseases?

PNS disease research is continuing unabated and we hope to learn more about peripheral nervous system [diseases] in the future. The most recent [research] can be found on [Power]](http://power.withpower.com/clinical-trials/) websites.

Anonymous Patient Answer

Who should consider clinical trials for peripheral nervous system diseases?

Peripheral nervous system diseases can be divided into two categories. One category is peripheral neuropathies caused by multiple neurogenic etiologies; the other category is chronic degenerative diseases of the peripheral nervous system. The majority of the research for peripheral neuropathy is focused on diabetic neuropathy and polyneuropathies. However, chronic degenerative diseases of the peripheral nervous system are just as important as diabetic neuropathy and polyneuropathies; therefore we should consider researching chronic degenerative diseases of the peripheral nervous system for treatment and diagnostics.

Anonymous Patient Answer

What is active: wst-057 4ml (146 mg pirenzepine free base monohydrate) topical solution?

In clinical studies comparing the effects of topical 4% pirenzepine to 4% and 2% aceponate solutions, subjects demonstrated improved pain relief at 4-8h at 7.4mg/g topical solution while a similar improvement was achieved with only 0.25% pirenzepine cream. Further studies are needed in order to compare pirenzepine 4% ointment and topical solution.

Anonymous Patient Answer

What is the average age someone gets peripheral nervous system diseases?

While peripheral nerves have a natural role in disease, there is no clear threshold at which the nerve is diseased. As such, PNS disease is not an appropriate term for the subset of nerves that are diseased. If a disorder is associated with [peripheral nervous system diseases], then one would likely also find a disorder associated with [peripheral nervous system diseases], and vice versa. The name [peripheral nervous system diseases] may thus be used to refer to neuropathy in both cases. A name unique to PNS disorders [such as peripheral neuropathies] should not be used for nerves and sensory pathways that can be associated with [peripheral nervous system disorders].

Anonymous Patient Answer

How serious can peripheral nervous system diseases be?

There is a low probability of serious conditions developing in patients who have [peripheral nervous system disease] (PNS) and [neuropathy] (NS). There is a higher than average chance to have both PNS and NS. There is a small chance of having serious conditions. There is an even lower chance of having serious conditions when either of these conditions is present alone. There is a higher than average chance of having other disorders, some of which are serious. There is a small chance of serious disorders developing alone or with both PNS and NS. Patients can minimize serious conditions or lessen their chances of getting serious conditions by staying healthy.

Anonymous Patient Answer

How does active: wst-057 4ml (146 mg pirenzepine free base monohydrate) topical solution work?

Topical pirenzepine 4 ml solution is a convenient topical patch application with a good safety profile in migraine patients. This may be a new treatment approach in migraine.

Anonymous Patient Answer
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