Clinical trial NCT04082000: Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy
Official title: A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diabetic Neuropathy
Lead sponsor: Breath of Life International Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Percentage of patients with >30% reduction in neuropathic pain
timeFrame: Baseline to week 15
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: First treatment upto 15 weeks
Secondary outcomes:
measure: Improvement of QoL from baseline
timeFrame: Baseline to 15 weeks
measure: Change in HbA1c
timeFrame: Baseline to 15 weeks
measure: Percentage of patients achieving HbA1c < 7%
timeFrame: Baseline to 15 weeks
measure: Change from baseline of blood pressure
timeFrame: Baseline to 15 weeks
measure: Change in weight
timeFrame: Baseline to 15 weeks
measure: Improvement in sleep disturbance
timeFrame: Baseline to 15 weeks
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Wolfson Medical Center
Study officials:
References: