Loading clinical trials...

UNKNOWNPHASE3

Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy

NCT06071975•Apurano Pharmaceuticals GmbH

Summary

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with pain disorders due to diabetic polyneuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to diabetic polyneuropathy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed and dated informed consent form
•2. Patients with chronic pain due to diabetic polyneuropathy since at least 3 months
•3. Female and male patients (\> 18 years)
•4. Patients with more than 1 year life expectancy
•5. Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
•6. Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
•7. Good command of German language, in order to understand questionnaires in German
•8. Current moderate to severe pain with pain intensity \> 5 on Numeric Rating Scale (NRS, 0 - 10) and thus an existing need for further pain therapy
•9. Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points

Exclusion Criteria

•1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
•2. Known intolerance to cannabinoids or cannabis products.
•3. Participation in another clinical trial within the last four weeks prior to inclusion.
•4. Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
•5. Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
•6. Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
•7. Known use of medicinal cannabis products within the last 8 weeks
•8. Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
•9. Known history of severe liver or kidney diseases
•10. Known history of severe cardiovascular disease
+5 more criteria

Locations (1)

Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie)

Munich, Bavaria, Germany

Key Dates

Start Date

November 2, 2023

Primary Completion Date

September 30, 2024

Completion Date

December 31, 2024

Last Updated

January 31, 2024

Enrollment

558

ESTIMATED participants

Conditions

PainPain SyndromePain, ChronicChronic PainChronic Pain SyndromeDiabetesDiabetic NeuropathiesDiabetic PolyneuropathyPeripheral NeuralgiaPeripheral NeuropathyPeripheral Neuropathy With Type 2 Diabetis

Interventions

Adezunap (AP707)

DRUG

Placebo

DRUG

Contacts

Marko Blisse

CONTACT

+49 8024 46869 28 marko.blisse@apurano.de

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

NCT06346132

Virtual RealityMedical Device+2 more

View study

RECRUITINGPHASE1

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy

Inclusion Criteria

Exclusion Criteria

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy

Intertransverse Process Block to Improve Quality of Recovery and Pain Management in Adult Cardiac Surgical Patients

Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination

Turkish Validity and Reliability of the Behavioral Indicators of Pain Scale(ESCID)