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

• Status: Terminated
• Trial end date: 2020-11-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Breath of Life International Pharma Ltd

Criteria

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.