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

Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04082000
• Other study ID #: BOL-P-4
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 15, 2019
• Est. completion date: November 4, 2020

Study information

• Verified date: March 2021
• Source: Breath of Life International Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Drug:
• BOL-DP-o-04
BOL-DP-o-04
• Placebo
Placebo

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	H_olon

Sponsors (1)

Lead Sponsor	Collaborator
Breath of Life International Pharma Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with >30% reduction in neuropathic pain	Assessed by the DN4 questionnaire	Baseline to week 15
Primary	Adverse Events (AEs) and Serious Adverse Events (SAEs)	All AEs will be recorded, whether considered minor or serious, drug-related or not	First treatment upto 15 weeks
Secondary	Improvement of QoL from baseline	Assessed by Diabetes Quality of Life Questionnaire (DQOL) questionnaire	Baseline to 15 weeks
Secondary	Change in HbA1c	Assessed by HbA1c blood levels	Baseline to 15 weeks
Secondary	Percentage of patients achieving HbA1c < 7%	Assessed by HbA1c blood levels	Baseline to 15 weeks
Secondary	Change from baseline of blood pressure	blood pressure measurement	Baseline to 15 weeks
Secondary	Change in weight	weight measured by Kg	Baseline to 15 weeks
Secondary	Improvement in sleep disturbance	Assessed by the sleep disturbance (PSQI) questionnaire	Baseline to 15 weeks