- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05416931
ACD440 Gel in Peripheral Neuropathic Pain
March 22, 2023 updated by: AlzeCure Pharma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Uppsala, Sweden, 75185
- Akademiska Sjukhuset
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACD440 Gel 14mg/g
Topically applied to painful neuropathic area twice daily for 7 days
|
Topical application to painful area
|
Placebo Comparator: Placebo Gel
Topically applied to painful neuropathic area twice daily for 7 days
|
Topical application to painful area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Change from baseline to Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of neuropathic pain
Time Frame: Baseline and day 7 of the respective treatment period
|
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.
|
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
|
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.
|
Baseline and day 7 of the respective treatment period
|
Patient Global Impression of Change (PGIC)
Time Frame: Day 7 of the respective treatment period
|
Rating on a 7-step verbal scale: much worse - worse - a little worse - no difference - a little better - better - much better.
|
Day 7 of the respective treatment period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability
Time Frame: From enrollment through study completion on Day 42.
|
Incidence of Treatment-Emergent Adverse Events as assessed by spontaneous reporting and by laboratory measures and electrocardiogram (ECG)
|
From enrollment through study completion on Day 42.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2022
Primary Completion (Actual)
March 10, 2023
Study Completion (Actual)
March 10, 2023
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
June 13, 2022
First Posted (Actual)
June 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8000-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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