Neuropathic PainPhase 4NCT07296354
Evaluation of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy
A Phase 4 study testing adenosine triphosphate and Vitamin B Complex in people with Neuropathic Pain, run by Egyptian International Pharmaceutical Industries Co.
Trial summary
Epinosine B Forte ampoule is an intramuscular injectable supplement containing adenosine triphosphate (ATP), Cocarboxylase (vitamin B1 derivative), vitamin B12, and nicotinamide (vitamin B3). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- adenosine triphosphate and Vitamin B Complex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 10 Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age at time of consent
- Able to provide informed consent for study participation.
- Diagnosed with either Type 1 or Type 2 diabetes mellitus, with glycated hemoglobin (HbA1c) ≤ 10%
- Diagnosed with diabetic polyneuropathy, defined as a Diabetic Neuropathy Symptom (DNS) score ≥ 2, with symptom duration of at least 3 months prior to providing informed consent.
- Willingness to comply with study procedures and attend scheduled study visits
- Patients should be on a stable antidiabetic medication regimen for 30 days prior to randomization.
Who cannot join
- Non-diabetic causes of neuropathy, e.g., alcohol abuse, vitamin B12 deficiency, renal failure, or chemotherapy-induced neuropathy other diseases that causes presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
- Current or recent (within 30 days from screening visit) use of Neuropathic pain treatments, including:
- 2.1 Gabapentinoids (gabapentin, pregabalin),
- 2.2Serotonin-norepinephrine reuptake inhibitors (duloxetine, venlafaxine, desvenlafaxine)
- 2.3 Tricyclic antidepressants (e.g., amitriptyline) 2.4 Topical capsaicin preparations 2.5 Carbamazepine, 2.6 Oxcarbazepine, 2.7 Lamotrigine 2.8 topiramate 2.9 other agents for neuropathic pain , Sedatives and anxiolytics (Benzodiazepines, Z-drugs (e.g., zolpidem), Barbiturates, Other B-complex or ATP-containing injectable supplements 2.10 Multivitamins or nutritional supplements 2.11 Pentoxifylline or Naftidrofuryl oxalate, Alpha-lipoic acid or other drug classes indicated for treatment of neuropathic pain.
- Severe comorbidities (e.g., malignancy, liver failure, end-stage renal disease, decompensated heart failure)
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- Pregnancy or breastfeeding
- Female patients of childbearing potential not using effective contraception (e.g., oral contraceptives, DMPA, IUD, double barrier, sterilization, or confirmed postmenopausal status)
- Known hypersensitivity to any component of the investigational product
- Participation in another clinical trial within the past 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized, Double-Blind Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy
Epinosine B Forte ampoule is an intramuscular injectable supplement containing adenosine triphosphate (ATP), Cocarboxylase (vitamin B1 derivative), vitamin B12, and nicotinamide (vitamin B3). It is used to support nerve function, treat B vitamin deficiencies, enhance cellular energy metabolism, and alleviate symptoms of fatigue, neuropathy, and general weakness. Commonly prescribed for conditions like peripheral neuritis and recovery from nerve-related disorders. Side effects are generally mild and may include local injection site reactions or allergic responses. Clinical evaluation of this investigational product may provide valuable evidence for its efficacy in treating diabetic neuropathy where impaired energy metabolism and micronutrient deficits often coexist. Establishing the efficacy and safety of Epinosine B Forte through a structured clinical trial is therefore essential. Demonstrating clinical benefit would not only inform and optimize current treatment protocols for DPN but also support the potential for broader clinical application which includes routine use in diabetic care, integration into treatment guidelines, and possible extension to other neuropathic conditions where metabolic support may play a therapeutic role
Read the detailed description
To evaluate the effectiveness of the IMP (Epinosine - B Forte Lyophilized Ampoules) compared to an active control (vitamin B complex only) in improving neuropathic symptoms in patients with symptomatic diabetic polyneuropathy based on a validated neurological symptom scoring system.
- Conditions
- Neuropathic Pain
- Being tested
- adenosine triphosphate, Vitamin B Complex
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenosine triphosphateDrug
Each lyophilized ampoule contains:
Adenosine Triphosphate (ATP) - 10 mg Cocarboxylase (Vitamin B1 derivative) - 50 mg Nicotinamide (Vitamin B3) - 20 mg Vitamin B12 (Cyanocobalamin) - 500 mcg
Vitamin B ComplexDrug
Each ampoule contains:
Cocarboxylase 50 mg Vitamin B12 500 mcg Nicotinamide 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Epinosine - B Forte Lyophilized | Active comparator | The investigational medicinal product is Epinosine B Forte, a parenteral formulation administered by intramuscular injection Receives: Drug: adenosine triphosphate |
| vitamin B complex only | Placebo comparator | The active control is a vitamin B-complex injectable formulation that does not contain ATP; manufactured by the sponsor specifically for clinical trial use only Receives: Drug: Vitamin B Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the mean change in Diabetic Neuropathy symptoms Score (DNS) from baseline to week 12 between the two study arms
A simplified scoring system, the diabetic neuropathy symptom score (DNS) frequently used in clinical trials and medical practice , assessing pain, numbness, tingling and ataxia. The maximum score of DNS is four points, one point or more indicates neurological abnormalities . It was reported to be validated, fast and easy to perform, with a high predictive value when screening for diabetic polyneuropathy . DNS was found to be the most and modified NDS had equal specificity (100%). DNS had a better diagnostic efficacy (70 %) ]sensitive test (65.4%)
Measured: 12 weeks
Secondary outcomes (2)
Neuropathy- and foot ulcer-specific quality of life (Neuro-QoL)
Neuro-QoL (Quality of Life in Neurological Disorders) is a validated patient-reported outcome measurement system developed to assess the physical, mental, and social health-related quality of life (HRQoL) in individuals living with neurological conditions. It is applicable across various disorders, including diabetic polyneuropathy.
The version used in this study consists of 35 items, grouped into the following components:
- 27 items covering six life domains: o Pain (7 items)
- Loss or reduction of sensitivity (3 items)
- Diffuse sensory-motor symptoms (3 items)
- Limitations in daily activities (3 items)
- Interpersonal problems (4 items)
- Emotional distress (7 items)
- 6 global items, one appended to each domain (labeled A-F), assessing the overall perceived impact of that domain on HRQoL.
- 2 final items: o One assessing the overall impact of foot problems on HRQoL.
- One providing a general global rating of the participant's HRQoL.
Measured: 12 weeks
Vibration perception threshold
The VPT will be tested on the pulp of the large toe of either right or left foot. Average of three measurements will be taken to calculate the VPT value of the given patient. Values will be recorded in the CRF. The VPT values will be graded as 'normal' (<15v), 'mild' (15-20v), 'moderate' (20-25v) and >25 as 'severe' neuropathy ( Martin, C.L., et al.,, 2010).
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion10 Feb 2028 (estimated)
- Study completion10 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egyptian International Pharmaceutical Industries Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296354
- Sponsor's protocol ID
- ABOVE
- Other IDs
- ABOVE-2501
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT07296354
- Acronym / sponsor ID
- ABOVE
- Conditions
- Neuropathic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Egyptian International Pharmaceutical Industries CoIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Feb 2028 (estimated)
- Study completion
- 10 Jan 2029 (estimated)
- First posted
- 22 Dec 2025 (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.
Epinosine B Forte ampoule is an intramuscular injectable supplement containing adenosine triphosphate (ATP), Cocarboxylase (vitamin B1 derivative), vitamin B12, and nicotinamide (vitamin B3). It is used to support nerve function, treat B vitamin deficiencies, enhance cellular energy metabolism, and alleviate symptoms of fatigue, neuropathy, and general weakness. Commonly prescribed for conditions like peripheral neuritis and recovery from nerve-related disorders. Side effects are generally mild and may include local injection site reactions or allergic responses. Clinical evaluation of this investigational product may provide valuable evidence for its efficacy in treating diabetic neuropathy where impaired energy metabolism and micronutrient deficits often coexist. Establishing the efficacy and safety of Epinosine B Forte through a structured clinical trial is therefore essential. Demonstrating clinical benefit would not only inform and optimize current treatment protocols for DPN but also support the potential for broader clinical application which includes routine use in diabetic care, integration into treatment guidelines, and possible extension to other neuropathic conditions where metabolic support may play a therapeutic role
Detailed description
To evaluate the effectiveness of the IMP (Epinosine - B Forte Lyophilized Ampoules) compared to an active control (vitamin B complex only) in improving neuropathic symptoms in patients with symptomatic diabetic polyneuropathy based on a validated neurological symptom scoring system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinosine - B Forte Lyophilized | Active comparator | Drug: adenosine triphosphateThe investigational medicinal product is Epinosine B Forte, a parenteral formulation administered by intramuscular injection |
| vitamin B complex only | Placebo comparator | Drug: Vitamin B ComplexThe active control is a vitamin B-complex injectable formulation that does not contain ATP; manufactured by the sponsor specifically for clinical trial use only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years of age at time of consent
- Able to provide informed consent for study participation.
- Diagnosed with either Type 1 or Type 2 diabetes mellitus, with glycated hemoglobin (HbA1c) ≤ 10%
- Diagnosed with diabetic polyneuropathy, defined as a Diabetic Neuropathy Symptom (DNS) score ≥ 2, with symptom duration of at least 3 months prior to providing informed consent.
- Willingness to comply with study procedures and attend scheduled study visits
Key exclusion criteria (10 listed)
- Non-diabetic causes of neuropathy, e.g., alcohol abuse, vitamin B12 deficiency, renal failure, or chemotherapy-induced neuropathy other diseases that causes presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
- Current or recent (within 30 days from screening visit) use of Neuropathic pain treatments, including:
- 2.1 Gabapentinoids (gabapentin, pregabalin),
- 2.2Serotonin-norepinephrine reuptake inhibitors (duloxetine, venlafaxine, desvenlafaxine)
- 2.3 Tricyclic antidepressants (e.g., amitriptyline) 2.4 Topical capsaicin preparations 2.5 Carbamazepine, 2.6 Oxcarbazepine, 2.7 Lamotrigine 2.8 topiramate 2.9 other agents for neuropathic pain , Sedatives and anxiolytics (Benzodiazepines, Z-drugs (e.g., zolpidem), Barbiturates, Other B-complex or ATP-containing injectable supplements 2.10 Multivitamins or nutritional supplements 2.11 Pentoxifylline or Naftidrofuryl oxalate, Alpha-lipoic acid or other drug classes indicated for treatment of neuropathic pain.
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 |
|---|---|---|
| adenosine triphosphateEach lyophilized ampoule contains: Adenosine Triphosphate (ATP) - 10 mg Cocarboxylase (Vitamin B1 derivative) - 50 mg Nicotinamide (Vitamin B3) - 20 mg Vitamin B12 (Cyanocobalamin) - 500 mcg | Drug | Epinosine - B Forte Lyophilized |
| Vitamin B ComplexEach ampoule contains: Cocarboxylase 50 mg Vitamin B12 500 mcg Nicotinamide 20 mg | Drug | vitamin B complex only |
Primary outcome
To compare the mean change in Diabetic Neuropathy symptoms Score (DNS) from baseline to week 12 between the two study arms
Time frame: 12 weeks
A simplified scoring system, the diabetic neuropathy symptom score (DNS) frequently used in clinical trials and medical practice , assessing pain, numbness, tingling and ataxia. The maximum score of DNS is four points, one point or more indicates neurological abnormalities . It was reported to be validated, fast and easy to perform, with a high predictive value when screening for diabetic polyneuropathy . DNS was found to be the most and modified NDS had equal specificity (100%). DNS had a better diagnostic efficacy (70 %) ]sensitive test (65.4%)
2 secondary outcomes
Neuropathy- and foot ulcer-specific quality of life (Neuro-QoL)
Time frame: 12 weeks
Vibration perception threshold
Time frame: 12weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adenosine triphosphate and Vitamin B Complex in people with Neuropathic Pain, run by Egyptian International Pharmaceutical Industries Co.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Momtaz, pHD (00201008676724, mohamed.momtaz@eipico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the mean change in Diabetic Neuropathy symptoms Score (DNS) from baseline to week 12 between the two study arms (time frame: 12 weeks). 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 22 Dec 2025.