Status:
TERMINATED
Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy
Lead Sponsor:
Breath of Life International Pharma Ltd
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04082000
Start Date
April 15 2019
End Date
November 4 2020
Last Update
March 24 2021
Active Locations (1)
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1
Wolfson Medical Center
Holon, Israel, 58100