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

Primary Purpose

Diabetic Neuropathy

Status

Terminated

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

BOL-DP-o-04

Placebo

About this trial

This is an interventional treatment trial for Diabetic Neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects with Type 1 or Type 2 diabetes
Diabetes duration of at least 1 year
HbA1c 6%-12%
18 years of age or older
Diabetic neuropathy for at least 6 months
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
Score equal or above 50% in DN4 questionnaire

Exclusion Criteria:

Neuropathic pain other than diabetic
A score of less than 50% on DN4 questionnaire
History of substance abuse (alcohol / illegal drugs)
History of cannabis or cannabis product usage in the last three months
Any decompensated chronic disease
Pregnancy/lactation
Participant in other clinical trial during the last 30 days
A current of history of cancer during the last year
Any mental/psychiatric illness in first-degree relative in a young patient <30 years old.
Any food allergy
History of amputation
Any disorder which in the investigator's opinion might jeopardize the subject's safety or compliance with the protocol
Patients with known allergy to one or more of the study drug components.
Patient with uncontrolled congestive heart failure
Subjects who get the following medications: opiates, Primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum
Patients with psychotic state in the past or anxiety disorder
Subject with a history of addiction or drug abuse.

Sites / Locations

Wolfson Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BOL-DP-o-04

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with >30% reduction in neuropathic pain

Assessed by the DN4 questionnaire

Adverse Events (AEs) and Serious Adverse Events (SAEs)

All AEs will be recorded, whether considered minor or serious, drug-related or not

Secondary Outcome Measures

Improvement of QoL from baseline

Assessed by Diabetes Quality of Life Questionnaire (DQOL) questionnaire

Change in HbA1c

Assessed by HbA1c blood levels

Percentage of patients achieving HbA1c < 7%

Assessed by HbA1c blood levels

Change from baseline of blood pressure

blood pressure measurement

Change in weight

weight measured by Kg

Improvement in sleep disturbance

Assessed by the sleep disturbance (PSQI) questionnaire

Full Information

NCT ID

NCT04082000

First Posted

August 31, 2019

Last Updated

March 22, 2021

Sponsor

Breath of Life International Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04082000

Brief Title

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

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

study stopped due to company strategic prioritization

Study Start Date

April 15, 2019 (Actual)

Primary Completion Date

November 4, 2020 (Actual)

Study Completion Date

November 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Breath of Life International Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Double-blind

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Triple (Participant, Investigator, Outcomes Assessor)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BOL-DP-o-04

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BOL-DP-o-04

Intervention Description

BOL-DP-o-04

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Percentage of patients with >30% reduction in neuropathic pain

Description

Assessed by the DN4 questionnaire

Time Frame

Baseline to week 15

Title

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

All AEs will be recorded, whether considered minor or serious, drug-related or not

Time Frame

First treatment upto 15 weeks

Secondary Outcome Measure Information:

Title

Improvement of QoL from baseline

Description

Assessed by Diabetes Quality of Life Questionnaire (DQOL) questionnaire

Time Frame

Baseline to 15 weeks

Title

Change in HbA1c

Description

Assessed by HbA1c blood levels

Time Frame

Baseline to 15 weeks

Title

Percentage of patients achieving HbA1c < 7%

Description

Assessed by HbA1c blood levels

Time Frame

Baseline to 15 weeks

Title

Change from baseline of blood pressure

Description

blood pressure measurement

Time Frame

Baseline to 15 weeks

Title

Change in weight

Description

weight measured by Kg

Time Frame

Baseline to 15 weeks

Title

Improvement in sleep disturbance

Description

Assessed by the sleep disturbance (PSQI) questionnaire

Time Frame

Baseline to 15 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects with Type 1 or Type 2 diabetes Diabetes duration of at least 1 year HbA1c 6%-12% 18 years of age or older Diabetic neuropathy for at least 6 months 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 Score equal or above 50% in DN4 questionnaire Exclusion Criteria: Neuropathic pain other than diabetic A score of less than 50% on DN4 questionnaire History of substance abuse (alcohol / illegal drugs) History of cannabis or cannabis product usage in the last three months Any decompensated chronic disease Pregnancy/lactation Participant in other clinical trial during the last 30 days A current of history of cancer during the last year Any mental/psychiatric illness in first-degree relative in a young patient <30 years old. Any food allergy History of amputation Any disorder which in the investigator's opinion might jeopardize the subject's safety or compliance with the protocol Patients with known allergy to one or more of the study drug components. Patient with uncontrolled congestive heart failure Subjects who get the following medications: opiates, Primidone, Phenobarbitol, carbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum Patients with psychotic state in the past or anxiety disorder Subject with a history of addiction or drug abuse.

Facility Information:

Facility Name

Wolfson Medical Center

City

H̱olon

ZIP/Postal Code

58100

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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