A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy
Overview
- Phase
- Phase 1
- Intervention
- BOL-DP-o-04
- Conditions
- Diabetic Neuropathy
- Sponsor
- Breath of Life International Pharma Ltd
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Percentage of patients with >30% reduction in neuropathic pain
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects with Type 1 or Type 2 diabetes
- •Diabetes duration of at least 1 year
- •HbA1c 6%-12%
- •18 years of age or older
- •Diabetic neuropathy for at least 6 months
- •Failed or uncontrolled treatment of diabetic neuropathy following treatment with at least two drugs from the following drug list (Pregabalin / Dulexatine/ Amitriptyline / gabapentin /carbamazepine) for a duration of at least three months for each drug
- •Score equal or above 50% in DN4 questionnaire
Exclusion Criteria
- •Neuropathic pain other than diabetic
- •A score of less than 50% on DN4 questionnaire
- •History of substance abuse (alcohol / illegal drugs)
- •History of cannabis or cannabis product usage in the last three months
- •Any decompensated chronic disease
- •Pregnancy/lactation
- •Participant in other clinical trial during the last 30 days
- •A current of history of cancer during the last year
- •Any mental/psychiatric illness in first-degree relative in a young patient \<30 years old.
- •Any food allergy
Arms & Interventions
BOL-DP-o-04
Intervention: BOL-DP-o-04
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of patients with >30% reduction in neuropathic pain
Time Frame: Baseline to week 15
Assessed by the DN4 questionnaire
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: First treatment upto 15 weeks
All AEs will be recorded, whether considered minor or serious, drug-related or not
Secondary Outcomes
- Improvement of QoL from baseline(Baseline to 15 weeks)
- Change from baseline of blood pressure(Baseline to 15 weeks)
- Change in weight(Baseline to 15 weeks)
- Change in HbA1c(Baseline to 15 weeks)
- Percentage of patients achieving HbA1c < 7%(Baseline to 15 weeks)
- Improvement in sleep disturbance(Baseline to 15 weeks)