Peripheral Neuropathic PainPhase 2NCT05416931
ACD440 Gel in Peripheral Neuropathic Pain
A Phase 2 study testing ACD440 Gel 14mg/g in people with Peripheral Neuropathic Pain, run by AlzeCure Pharma at 1 site in Sweden.
Trial summary
This is a double-blind, randomized, placebo-controlled crossover outpatient study in patients with peripheral neuropathic pain with allodynia or hyperalgesia to cold, heat, brush and/ or pinprick stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Neuropathic Pain
- What is being tested?
- ACD440 Gel 14mg/g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jun 2022to 10 Mar 2023
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study related procedures.
- Male or female between 18 and 80 years of age, inclusive, at the screening visit.
- Diagnosed with painful peripheral polyneuropathy (PNP), including etiologies behind the PNP being but not limited to painful peripheral polyneuropathy, peripheral mononeuropathy, postherpetic neuralgia (PHN), chemotherapy induced neuropathic pain, nerve injury pain, chronic postoperative neuropathic pain with a history of 6 months to 7 years prior to the screening visit.
- Hypersensitivity to one or more of the following sensory stimuli: mechanical (brush or pinprick), thermal (cold).
- Pain intensity of 4-7 out of 10 on a numerical rating scale (NRS) to any of the sensory stimuli mentioned in inclusion criterion
- The area of sensory hypersensitivity can be up to a total of 600 cm2.
- Subjects with reproductive potential will need to use accepted and highly effective means of contraception from study entry until at least 6 weeks for females (women of childbearing potential, WOCP) and 3 months for males after IMP discontinuation (as per the Clinical Trials Facilitation and Coordination Group (CTFG) guidelines).
Who cannot join
- Participated in a clinical study and received active drug in such a study within 30 days or 5 study drug half-lives, whichever the longest, prior to screening visit.
- A body mass index (BMI) <18.5 kg/m2 or >35 kg/m2.
- Serum aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) levels >2 times the upper limit of normal (ULN) at the screening assessments.
- Evidence and/or history of any clinically significant neurological disease, other systemic diseases or conditions potentially interfering with study assessments, as judged by the investigator.
- Have another concomitant pain condition with an intensity of ≥4 out of 10, for which, as judged by the principal investigator, pain ratings may interfere with study assessments.
- Have a Hospital Anxiety and Depression Scale (HADS) score of 15 or above.
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- Active Human immunodeficiency virus (HIV) or ongoing hepatitis B and/or C.
- Ongoing infection with fever (i.e., body temperature >38.0 ˚C).
- Known history of hypersensitivity to components of the study drug or a history of anaphylactic reactions.
- Malignancy within the past 5 years. In situ basal cell carcinoma and in situ squamous cell carcinoma of the skin are exempt, unless localised to the area of neuropathic pain.
- History of dermatological diseases including rosacea, syphilitic and tuberculotic reactions.
- Open wounds, scars, as well as extended tattoos on intended treatment areas.
- Skin infections, acne, skin inflammation, eczema, or other dermatological disorders in the intended treatment area.
- Pregnant or breastfeeding female or female who is planning pregnancy during the study period.
- Could be negatively affected by participation in the study, as judged by the investigator.
- Diagnosed with any significant psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5® criteria, including drug abuse or dependency.
- Daily intake of opioids at a daily dose of more than 60 morphine equivalents.
- Use of Lidocaine patches within 7 days prior to randomisation until the follow-up visit.
- Use of Capsaicin patches within 4 months prior to randomisation until the follow-up visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Crossover Study to Explore the Effects of ACD440 in Patients With Peripheral Neuropathic Pain With Sensory Hypersensitivity.
This is a double-blind, randomized, placebo-controlled crossover outpatient study in patients with peripheral neuropathic pain with allodynia or hyperalgesia to cold, heat, brush and/ or pinprick stimulation. Patients will in random order receive ACD440 Gel or placebo treatment twice daily for 7 days, topically applied to the painful area. This is followed by a 2-week washout period, then receive the alternate treatment.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- ACD440 Gel 14mg/g, Placebo Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACD440 Gel 14mg/gDrug
Topical application to painful area
Placebo GelDrug
Topical application to painful area
| Study group | Role | What they receive |
|---|---|---|
| ACD440 Gel 14mg/g | Experimental | Topically applied to painful neuropathic area twice daily for 7 days Receives: Drug: ACD440 Gel 14mg/g |
| Placebo Gel | Placebo comparator | Topically applied to painful neuropathic area twice daily for 7 days Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulus evoked pain
Pain evoked by stimulus: brushing pain, pressure pain or cold pain, subitems 8-10 of the Neuropathic Pain Symptom Inventory (NPSI).
Intensity is scored on a scale from 0-10, where 0 means no pain and 10 means worst pain possible.
Measured: Change from baseline to Day 7
Secondary outcomes (3)
Symptoms of neuropathic pain
Intensity of symptoms of neuropathic pain assessed by the Neuropathic Pain Symptom Inventory (NPSI). The NPSI total score ranges from 0 to 50, where 0 depicts absence of pain and 50 is the worst score.
Measured: Baseline and day 7 of the respective treatment period
Intensity of spontaneous pain on a numerical rating scale (NRS)
Spontaneous pain intensity during the last 24-hours, rated on a Numerical Rating Scale (NRS), where score range from 0-10, where 0 means no pain and 10 means worst pain possible.
Measured: Baseline and day 7 of the respective treatment period
Patient Global Impression of Change (PGIC)
Rating on a 7-step verbal scale: much worse - worse - a little worse - no difference - a little better - better - much better.
Measured: Day 7 of the respective treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start20 Jun 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlzeCure Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416931
- Sponsor's protocol ID
- D8000-003
- Status last verified
- Mar 2023
- First submitted
- 24 May 2022
- Last updated
- 23 Mar 2023
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled Crossover Study to Explore the Effects of ACD440 in Patients With Peripheral Neuropathic Pain With Sensory Hypersensitivity.
- ClinicalTrials.gov ID
- NCT05416931
- Acronym / sponsor ID
- D8000-003
- Conditions
- Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AlzeCure PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 14 Jun 2022 (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.
This is a double-blind, randomized, placebo-controlled crossover outpatient study in patients with peripheral neuropathic pain with allodynia or hyperalgesia to cold, heat, brush and/ or pinprick stimulation. Patients will in random order receive ACD440 Gel or placebo treatment twice daily for 7 days, topically applied to the painful area. This is followed by a 2-week washout period, then receive the alternate treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACD440 Gel 14mg/g | Experimental | Drug: ACD440 Gel 14mg/gTopically applied to painful neuropathic area twice daily for 7 days |
| Placebo Gel | Placebo comparator | Drug: Placebo GelTopically applied to painful neuropathic area twice daily for 7 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent prior to any study related procedures.
- Male or female between 18 and 80 years of age, inclusive, at the screening visit.
- Diagnosed with painful peripheral polyneuropathy (PNP), including etiologies behind the PNP being but not limited to painful peripheral polyneuropathy, peripheral mononeuropathy, postherpetic neuralgia (PHN), chemotherapy induced neuropathic pain, nerve injury pain, chronic postoperative neuropathic pain with a history of 6 months to 7 years prior to the screening visit.
- Hypersensitivity to one or more of the following sensory stimuli: mechanical (brush or pinprick), thermal (cold).
- Pain intensity of 4-7 out of 10 on a numerical rating scale (NRS) to any of the sensory stimuli mentioned in inclusion criterion
Key exclusion criteria (19 listed)
- Participated in a clinical study and received active drug in such a study within 30 days or 5 study drug half-lives, whichever the longest, prior to screening visit.
- A body mass index (BMI) <18.5 kg/m2 or >35 kg/m2.
- Serum aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) levels >2 times the upper limit of normal (ULN) at the screening assessments.
- Evidence and/or history of any clinically significant neurological disease, other systemic diseases or conditions potentially interfering with study assessments, as judged by the investigator.
- Have another concomitant pain condition with an intensity of ≥4 out of 10, for which, as judged by the principal investigator, pain ratings may interfere with study assessments.
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 |
|---|---|---|
| ACD440 Gel 14mg/gTopical application to painful area | Drug | ACD440 Gel 14mg/g |
| Placebo GelTopical application to painful area | Drug | Placebo Gel |
Primary outcome
Stimulus evoked pain
Time frame: Change from baseline to Day 7
Pain evoked by stimulus: brushing pain, pressure pain or cold pain, subitems 8-10 of the Neuropathic Pain Symptom Inventory (NPSI). Intensity is scored on a scale from 0-10, where 0 means no pain and 10 means worst pain possible.
3 secondary outcomes
Symptoms of neuropathic pain
Time frame: Baseline and day 7 of the respective treatment period
Intensity of spontaneous pain on a numerical rating scale (NRS)
Time frame: Baseline and day 7 of the respective treatment period
Patient Global Impression of Change (PGIC)
Time frame: Day 7 of the respective treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACD440 Gel 14mg/g in people with Peripheral Neuropathic Pain, run by AlzeCure Pharma at 1 site in Sweden.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 23 Mar 2023. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulus evoked pain (time frame: Change from baseline to Day 7). 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 23 Mar 2023.