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

NCT04082000 | Terminated Phase 1

• 1 other identifier: BOL-P-4
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with >30% reduction in neuropathic pain

  Assessed by the DN4 questionnaire

  Baseline to week 15

• 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 Outcomes (6)

• Improvement of QoL from baseline

  Baseline to 15 weeks

• Change in HbA1c

  Baseline to 15 weeks

• Percentage of patients achieving HbA1c < 7%

  Baseline to 15 weeks

• Change from baseline of blood pressure

  Baseline to 15 weeks

• Change in weight

  Baseline to 15 weeks

Study Arms (2)

BOL-DP-o-04

EXPERIMENTAL

Drug: BOL-DP-o-04

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BOL-DP-o-04 DRUG

BOL-DP-o-04

BOL-DP-o-04

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects with Type 1 or Type 2 diabetes
• Diabetes duration of at least 1 year
• HbA1c 6%-12%
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Breath of Life International Pharma Ltd: lead

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: September 9, 2019
• Study Start: April 15, 2019
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

IL (1)