Diabetic NeuropathyPhase 1/2NCT04082000
Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy
A Phase 1/2 study testing BOL-DP-o-04 in people with Diabetic Neuropathy, run by Breath of Life International Pharma Ltd at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- BOL-DP-o-04
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Apr 2019to 4 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy
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
Read the 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
- Conditions
- Diabetic Neuropathy
- Being tested
- BOL-DP-o-04, Placebo
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOL-DP-o-04Drug
BOL-DP-o-04
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BOL-DP-o-04 | Experimental | Not described Receives: Drug: BOL-DP-o-04 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with >30% reduction in neuropathic pain
Assessed by the DN4 questionnaire
Measured: 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
Measured: First treatment upto 15 weeks
Secondary outcomes (6)
Improvement of QoL from baseline
Assessed by Diabetes Quality of Life Questionnaire (DQOL) questionnaire
Measured: Baseline to 15 weeks
Change in HbA1c
Assessed by HbA1c blood levels
Measured: Baseline to 15 weeks
Percentage of patients achieving HbA1c < 7%
Assessed by HbA1c blood levels
Measured: Baseline to 15 weeks
Change from baseline of blood pressure
blood pressure measurement
Measured: Baseline to 15 weeks
Change in weight
weight measured by Kg
Measured: Baseline to 15 weeks
Improvement in sleep disturbance
Assessed by the sleep disturbance (PSQI) questionnaire
Measured: Baseline to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start15 Apr 2019
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Why it stopped: study stopped due to company strategic prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breath of Life International Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082000
- Sponsor's protocol ID
- BOL-P-4
- Status last verified
- Mar 2021
- First submitted
- 31 Aug 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT04082000
- Acronym / sponsor ID
- BOL-P-4
- Conditions
- Diabetic Neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study stopped due to company strategic prioritization
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Breath of Life International Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind
| Arm | Type | Receives |
|---|---|---|
| BOL-DP-o-04 | Experimental | Drug: BOL-DP-o-04 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOL-DP-o-04BOL-DP-o-04 | Drug | BOL-DP-o-04 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage of patients with >30% reduction in neuropathic pain
Time frame: Baseline to week 15
Assessed by the DN4 questionnaire
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First treatment upto 15 weeks
All AEs will be recorded, whether considered minor or serious, drug-related or not
6 secondary outcomes
Improvement of QoL from baseline
Time frame: Baseline to 15 weeks
Change in HbA1c
Time frame: Baseline to 15 weeks
Percentage of patients achieving HbA1c < 7%
Time frame: Baseline to 15 weeks
Change from baseline of blood pressure
Time frame: Baseline to 15 weeks
Change in weight
Time frame: Baseline to 15 weeks
Improvement in sleep disturbance
Time frame: Baseline to 15 weeks
Results and safety
The study was stopped early (reason given: study stopped due to company strategic prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BOL-DP-o-04 in people with Diabetic Neuropathy, run by Breath of Life International Pharma Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: study stopped due to company strategic prioritization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with >30% reduction in neuropathic pain (time frame: Baseline to week 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.