PainPhase 3NCT06072001
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
A Phase 3 study testing Adezunap (AP707) in people with Pain and Pain Syndrome, run by Apurano Pharmaceuticals GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain Syndrome, Pain, Chronic
- What is being tested?
- Adezunap (AP707)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 558 participants
- Where
- 1 siteGermany
- Study dates
- 2 Nov 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Patients with chronic pain due to central neuropathy of any genesis since at least 3 months
- Female and male patients (> 18 years)
- Patients with more than 1 year life expectancy
- Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
- Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
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- Good command of German language, in order to understand questionnaires in German
- 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
- Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points
Who cannot join
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- Known intolerance to cannabinoids or cannabis products.
- Participation in another clinical trial within the last four weeks prior to inclusion.
- Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
- Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
- Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
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- Known use of medicinal cannabis products within the last 8 weeks
- Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
- Known history of severe liver or kidney diseases
- Known history of severe cardiovascular disease
- Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
- Known history of addictive disease (e.g., alcohol, medication, drug addiction)
- Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
- 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
- Laboratory renal value: Serum creatinine > 1.5 ULN
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Rechts der Isar (Zentrum für Interdisziplinäre Schmerztherapie)
Munich, Bavaria, 81675
Katharina Haas
About this study
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 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.
- Conditions
- Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Neuropathic Pain
- Being tested
- Adezunap (AP707), Placebo
- Keywords
- Adezunap, Pain Therapy, Pain, Pain Syndrome, Chronic Pain, Chronic Pain Syndrome, Central Nervous System, CNS, Neuropathic Pain, Central Neuropathic Pain, Paraplegia, Multiple Sclerosis, Stroke, Phantom Limb Syndrome with Pain, Phantom Pain, Traumatic Brain Injury, THC, Tetrahydrocannabinol, Delta-9-Tetrahydrocannabinol, Cannabis
- Medical subject headings
- Pain, Somatoform Disorders, Chronic Pain, Neuralgia, Paraplegia, Multiple Sclerosis, Stroke, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adezunap (AP707)Drug
Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.
PlaceboDrug
Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes. Receives: Drug: Adezunap (AP707) |
| Control group | Experimental | Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Once daily in week 4 and 14
Secondary outcomes (14)
Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 26 (end of second treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
Measured: Once daily in week 4 and 26
Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 52 (end of third treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
Measured: Once daily in week 4 and 52
Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline and at treatment week 14, treatment week 26 and treatment week 52 in comparison of study arm 1 (verum) and study arm 2 (placebo)
Measured: Once in week 1, 14, 26 and 52
Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5, 11, 18, 22, 30, 34, 43, 47 in comparison of study arm 1 (verum) and study arm 2 (placebo)
Measured: Several times weekly in week 4, 5, 11, 18, 22, 30, 34, 43 and 47
Responder analysis for endpoints 1), 2), 3) and 4) for treatment week 14, 26 and 52
- Proportion of patients who experienced > 30 % improvement in pain score (Numeric Rating Scale)
- Proportion of patients who experienced > 40 % improvement in pain score (Numeric Rating Scale)
- Proportion of patients who experienced > 50 % improvement in pain score (Numeric Rating Scale)
Measured: Week 14, 26 and 52
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
Measured: Week 14
Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14, 26, and 52
Measured: Week 1, 14, 26 and 52
Change of Patient Global Impression of Change (PGIC) from start to week 14, 26, and 52
Measured: Week 14, 26 and 52
Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14, 26, and 52
Measured: Week 1, 14, 26 and 52
Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14, 26, and 52
Measured: Week 1, 14, 26 and 52
Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14, 26, and 52
Measured: Week 1, 14, 26 and 52
Area under NRS-curve until treatment week 5, 11, 14, 18, 22, 26, 30, 34, 39, 43, 47, 52
Measured: Week 5, 12, 18, 22, 26, 30, 34, 39, 43, 47 and 52
Change in VR-12 components (physical component summary PCS, mental component summary MCS) from start to week 14, 26, and 52
Measured: Week 1, 14, 26 and 52
Number of patients with rescue medication over the course of the clinical trial and within periods: until treatment week ≤5, ≤11, ≤14, ≤18, ≤22, ≤26, ≤30, ≤34, ≤43, ≤47, ≤52
Measured: Week 5, 11, 14, 18, 22, 26, 30, 34, 43, 47 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start2 Nov 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apurano Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072001
- Sponsor's protocol ID
- DISCOVER__(ZNP)
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 31 Jan 2024
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
- ClinicalTrials.gov ID
- NCT06072001
- Acronym / sponsor ID
- DISCOVER__(ZNP)
- Conditions
- Pain, Pain Syndrome, Pain, Chronic, Chronic Pain, Chronic Pain Syndrome, Neuropathic Pain
- Keywords
- Adezunap, Pain Therapy, Pain, Pain Syndrome, Chronic Pain, Chronic Pain Syndrome, Central Nervous System, CNS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Apurano Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Adezunap (AP707)Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes. |
| Control group | Experimental | Drug: PlaceboSublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form
- Patients with chronic pain due to central neuropathy of any genesis since at least 3 months
- Female and male patients (> 18 years)
- Patients with more than 1 year life expectancy
- Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
Key exclusion criteria (15 listed)
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- Known intolerance to cannabinoids or cannabis products.
- Participation in another clinical trial within the last four weeks prior to inclusion.
- Pregnant or nursing women (as excluded by pregnancy testing at visit 1).
- Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
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 |
|---|---|---|
| Adezunap (AP707)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 | Treatment group |
| PlaceboSublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes. | Drug | Control group |
Primary outcome
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)
Time frame: Once daily in week 4 and 14
14 secondary outcomes
Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 26 (end of second treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Once daily in week 4 and 26
Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 52 (end of third treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Once daily in week 4 and 52
Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline and at treatment week 14, treatment week 26 and treatment week 52 in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Once in week 1, 14, 26 and 52
Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5, 11, 18, 22, 30, 34, 43, 47 in comparison of study arm 1 (verum) and study arm 2 (placebo)
Time frame: Several times weekly in week 4, 5, 11, 18, 22, 30, 34, 43 and 47
Responder analysis for endpoints 1), 2), 3) and 4) for treatment week 14, 26 and 52
Time frame: Week 14, 26 and 52
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
Time frame: Week 14
Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Change of Patient Global Impression of Change (PGIC) from start to week 14, 26, and 52
Time frame: Week 14, 26 and 52
Change in quality of life using the Veterans RAND (VR-12) questionnaire from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Change in sleep quality using the Regensburg Insomnia Scale (RIS) from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Area under NRS-curve until treatment week 5, 11, 14, 18, 22, 26, 30, 34, 39, 43, 47, 52
Time frame: Week 5, 12, 18, 22, 26, 30, 34, 39, 43, 47 and 52
Change in VR-12 components (physical component summary PCS, mental component summary MCS) from start to week 14, 26, and 52
Time frame: Week 1, 14, 26 and 52
Number of patients with rescue medication over the course of the clinical trial and within periods: until treatment week ≤5, ≤11, ≤14, ≤18, ≤22, ≤26, ≤30, ≤34, ≤43, ≤47, ≤52
Time frame: Week 5, 11, 14, 18, 22, 26, 30, 34, 43, 47 and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adezunap (AP707) in people with Pain and Pain Syndrome, run by Apurano Pharmaceuticals GmbH at 1 site in Germany.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marko Blisse (+49 8024 46869 28, marko.blisse@apurano.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Once daily in week 4 and 14). 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 31 Jan 2024.