Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Drug: BOL-DP-o-04
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 History of amputation Any disorder which in the investigator's opinion might jeopardize the subject's safety or compliance with the protocol Patients with known allergy to one or more of the study drug components. Patient with uncontrolled congestive heart failure Subjects who get the following medications: opiates, Primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum Patients with psychotic state in the past or anxiety disorder Subject with a history of addiction or drug abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOL-DP-o-04<br> | Drug: BOL-DP-o-04<br>* BOL-DP-o-04<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with >30% reduction in neuropathic pain | Assessed by the DN4 questionnaire | 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 | First treatment upto 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of QoL from baseline | Assessed by Diabetes Quality of Life Questionnaire (DQOL) questionnaire | Baseline to 15 weeks | 
| Change in HbA1c | Assessed by HbA1c blood levels | Baseline to 15 weeks | 
| Percentage of patients achieving HbA1c < 7% | Assessed by HbA1c blood levels | Baseline to 15 weeks | 
| Change from baseline of blood pressure | blood pressure measurement | Baseline to 15 weeks | 
| Change in weight | weight measured by Kg | Baseline to 15 weeks | 
| Improvement in sleep disturbance | Assessed by the sleep disturbance (PSQI) questionnaire | Baseline to 15 weeks |