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

Phase 1

Terminated

• Conditions: Diabetic Neuropathy
• Interventions: Drug: Placebo; Drug: BOL-DP-o-04

• Registration Number: NCT04082000
• Lead Sponsor: Breath of Life International Pharma Ltd

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

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2019-08-31
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BOL-DP-o-04	BOL-DP-o-04	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change in weight	Baseline to 15 weeks	weight measured by Kg
Change in HbA1c	Baseline to 15 weeks	Assessed by HbA1c blood levels
Percentage of patients achieving HbA1c < 7%	Baseline to 15 weeks	Assessed by HbA1c blood levels
Improvement in sleep disturbance	Baseline to 15 weeks	Assessed by the sleep disturbance (PSQI) questionnaire

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 H̱olon, Israel