Peripheral Neuropathy Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 24-Week, Phase 2a Study of Topical Pirenzepine (WST-057) or Placebo in Type 2 Diabetic Patients With Peripheral Neuropathy
This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the safety, tolerability, and exploratory efficacy of topically administered WST-057 (4% pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral neuropathy.
This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the safety, tolerability, and exploratory efficacy of topically administered WST-057 (4% pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral neuropathy. Subjects will attend visits at screening (day -45 to -28); day 1 (baseline); weeks 2, 4, 8, 12, 16, 20, 24; and follow-up (week 26). Approximately 60 subjects with T2DM with peripheral neuropathy will be randomized to 1 of 4 treatment groups in a 1:1:4:4 ratio: placebo control 2 mL (n = 6 subjects), placebo control 4 mL (n = 6 subjects); low dose (2 mL) WST-057 (73 mg pirenzepine free base monohydrate) (n = 24 subjects); and high dose (4 mL) WST-057 (146 mg pirenzepine free base monohydrate) (n = 24 subjects), with the assumption that a total of 50 subjects will complete the study. This study is designed with 4 periods: screening, baseline/day 1, outpatient treatment, and safety follow-up. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05152368 -
Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy
|
Phase 1 | |
Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
Completed |
NCT02549534 -
Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
|
N/A | |
Active, not recruiting |
NCT02701075 -
MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
|
N/A | |
Completed |
NCT01196442 -
Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer
|
N/A | |
Completed |
NCT00763087 -
Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet
|
N/A | |
Completed |
NCT00079807 -
Painful HIV Neuropathy and Alpha-Lipoic Acid
|
Phase 1/Phase 2 | |
Completed |
NCT03292328 -
Yoga for Symptoms of Nerve Damage Caused by Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05379140 -
Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV
|
N/A | |
Recruiting |
NCT05673746 -
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
|
N/A | |
Completed |
NCT05189535 -
"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
|
Phase 2/Phase 3 | |
Recruiting |
NCT06219590 -
Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy
|
N/A | |
Enrolling by invitation |
NCT05595109 -
Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients
|
Phase 2/Phase 3 | |
Completed |
NCT05916118 -
Exercise and Oxaliplatin-induced Peripheral Neuropathy
|
N/A | |
Withdrawn |
NCT03881748 -
Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
|
N/A | |
Not yet recruiting |
NCT03112057 -
Visualize Nociceptor Changes in Neuropathic Human
|
N/A | |
Completed |
NCT02936843 -
Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy
|
Phase 2/Phase 3 | |
Terminated |
NCT01458015 -
Tapentadol Versus Oxycodon - a Mechanism-based Treatment Approach in Neuropathic Pain
|
Phase 4 | |
Completed |
NCT01006408 -
Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy
|
N/A | |
Completed |
NCT00471445 -
Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients
|
Phase 3 |