Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due t

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

Status unknownPhase 3MS (type not specified)NCT06071949

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Adezunap

Placebo

  • Placebo

What it measured

Main measures

  • Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 14 (end of first treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)

    Once daily in week 4 and 14

    Pain

Other measures (12)

  • Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline and at treatment week 14 in comparison of study arm 1 (verum) and study arm 2 (placebo)

    Week 1 and 14

    Pain

  • Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5 and 11 in comparison of study arm 1 (verum) and study arm 2 (placebo)

    Several times weekly in week 4, 5 and 11

    Pain

  • Responder analysis for endpoints 1) for treatment week 14

    Week 14

    Pain

  • Change in sCPT (percentage of change in dosage and percentage of change in combination of analgesic measures) in both study arms from start to week 14

    Week 14

  • Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14

    Week 1 and 14

    Mood and sleep

  • Change of Patient Global Impression of Change (PGIC) from start to week 14

    Week 14

  • Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14

    Week 1 and 14

    Quality of life (reported by participants)

  • Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14

    Week 1 and 14

    Mood and sleep

  • Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14

    Week 1 and 14

    Pain

  • Area under NRS-curve until treatment week 5, 11 and 14

    Week 5, 11 and 14

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Nov 2023

      2. Main results due

        Sept 2024

      3. Finished

        Dec 2024

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