Evaluation of an ATP-Containing Parenteral Vitamin B Complex in Patients With Symptomatic Diabetic Polyneuropathy

NCT07296354 | Not Yet Recruiting Phase 4

• 2 other identifiers: ABOVEABOVE-2501
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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%)

  12 weeks

Secondary Outcomes (2)

• Neuropathy- and foot ulcer-specific quality of life (Neuro-QoL)

  12 weeks

• Vibration perception threshold

  12weeks

Study Arms (2)

Epinosine - B Forte Lyophilized

ACTIVE COMPARATOR

The investigational medicinal product is Epinosine B Forte, a parenteral formulation administered by intramuscular injection

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

Drug: Vitamin B Complex

Interventions

adenosine triphosphate DRUG

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

Epinosine - B Forte Lyophilized

Vitamin B Complex DRUG

Each ampoule contains: Cocarboxylase 50 mg Vitamin B12 500 mcg Nicotinamide 20 mg

vitamin B complex only

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Gabapentinoids (gabapentin, pregabalin),
• Serotonin-norepinephrine reuptake inhibitors (duloxetine, venlafaxine, desvenlafaxine)
• 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)
• 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

Sponsors & Collaborators

• Egyptian International Pharmaceutical Industries Co: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Adenosine Triphosphate; Vitamin B Complex

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Mohamed A Momtaz, pHD

CONTACT

00201008676724; mohamed.momtaz@eipico.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 22, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): February 10, 2028
• Study Completion (Estimated): January 10, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share