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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04082000
Other study ID # BOL-P-4
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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