Diabetic Neuropathy
Conditions
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
Interventions
DRUGBOL-DP-o-04
BOL-DP-o-04
DRUGPlacebo
Placebo
Sponsors
Breath of Life International Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple (Participant, Investigator, Outcomes Assessor)
Intervention model description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with >30% reduction in neuropathic pain | Baseline to week 15 | Assessed by the DN4 questionnaire |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | First treatment upto 15 weeks | All AEs will be recorded, whether considered minor or serious, drug-related or not |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in sleep disturbance | Baseline to 15 weeks | Assessed by the sleep disturbance (PSQI) questionnaire |
| Improvement of QoL from baseline | Baseline to 15 weeks | Assessed by Diabetes Quality of Life Questionnaire (DQOL) questionnaire |
| Change from baseline of blood pressure | Baseline to 15 weeks | blood pressure measurement |
| Percentage of patients achieving HbA1c < 7% | Baseline to 15 weeks | Assessed by HbA1c blood levels |
| Change in HbA1c | Baseline to 15 weeks | Assessed by HbA1c blood levels |
| Change in weight | Baseline to 15 weeks | weight measured by Kg |
Countries
Israel
Outcome results
None listed