This is a randomized, double-blind, placebo-controlled Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy
A Phase 2a, two-center, randomized, double-blind, placebo-controlled study in which subjects will be randomized to receive either BOL-DP-o-04 or placebo in addition to Standart of Care. The study evaluates the effect of BOL-DP-o-04 for Diabetic Neuropathy. The study includes a screening period up to three weeks followed by a 12-week treatment period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
BOL-DP-o-04
Placebo
Wolfson Medical Center
Holon, Israel
Percentage of patients with >30% reduction in neuropathic pain
Assessed by the DN4 questionnaire
Time frame: Baseline to week 15
Adverse Events (AEs) and Serious Adverse Events (SAEs)
All AEs will be recorded, whether considered minor or serious, drug-related or not
Time frame: First treatment upto 15 weeks
Improvement of QoL from baseline
Assessed by Diabetes Quality of Life Questionnaire (DQOL) questionnaire
Time frame: Baseline to 15 weeks
Change in HbA1c
Assessed by HbA1c blood levels
Time frame: Baseline to 15 weeks
Percentage of patients achieving HbA1c < 7%
Assessed by HbA1c blood levels
Time frame: Baseline to 15 weeks
Change from baseline of blood pressure
blood pressure measurement
Time frame: Baseline to 15 weeks
Change in weight
weight measured by Kg
Time frame: Baseline to 15 weeks
Improvement in sleep disturbance
Assessed by the sleep disturbance (PSQI) questionnaire
Time frame: Baseline to 15 weeks
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