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

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

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

Inclusion Criteria:

1. Male or female subjects with Type 1 or Type 2 diabetes
2. Diabetes duration of at least 1 year
3. HbA1c 6%-12%
4. 18 years of age or older
5. Diabetic neuropathy for at least 6 months
6. 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
7. Score equal or above 50% in DN4 questionnaire

Exclusion Criteria:

1. Neuropathic pain other than diabetic
2. A score of less than 50% on DN4 questionnaire
3. History of substance abuse (alcohol / illegal drugs)
4. History of cannabis or cannabis product usage in the last three months
5. Any decompensated chronic disease
6. Pregnancy/lactation
7. Participant in other clinical trial during the last 30 days
8. A current of history of cancer during the last year
9. Any mental/psychiatric illness in first-degree relative in a young patient <30 years old.
10. Any food allergy
11. History of amputation
12. Any disorder which in the investigator's opinion might jeopardize the subject's safety or compliance with the protocol
13. Patients with known allergy to one or more of the study drug components.
14. Patient with uncontrolled congestive heart failure
15. Subjects who get the following medications: opiates, Primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum
16. Patients with psychotic state in the past or anxiety disorder
17. Subject with a history of addiction or drug abuse.