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Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis

Study Purpose

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 efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to central neuropathy of any genesis. 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 central neuropathy of any genesis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed and dated informed consent form. 2. Patients with chronic pain due to central neuropathy of any genesis 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. 11. Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder. 12. Known history of addictive disease (e.g., alcohol, medication, drug addiction) 13. Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry. 14. Laboratory liver values: Alanine aminotransferase (ALT, GPT) > 3 x ULN (Upper Limit of Normal range), Aspartate aminotransferase (AST, GOT) > 3 x ULN, Alkaline phosphatase (AP) > 2.5 x ULN, and for bilirubin > 1.5 x ULN. 15. Laboratory renal value: Serum creatinine > 1.5 ULN

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06071949
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Apurano Pharmaceuticals GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Neuropathic Pain, Central Neuropathic Pain, Paraplegia, Multiple Sclerosis, Stroke, Phantom Limb Syndrome With Pain, Phantom Pain, Traumatic Brain Injury

Arms & Interventions

Arms

Experimental: Treatment group

Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.

Experimental: Control group

Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.

Interventions

Drug: - Adezunap

Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.

Drug: - Placebo

Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Munich, Bavaria, Germany

Status

Recruiting

Address

Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie)

Munich, Bavaria, 81675

Site Contact

Katharina Haas

[email protected]

+49 8024 46869 28

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