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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent prior to any study related procedures.
  2. Male or female between 18 and 80 years of age, inclusive, at the screening visit.
  3. 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.
  4. Hypersensitivity to one or more of the following sensory stimuli: mechanical (brush or pinprick), thermal (cold).
  5. Pain intensity of 4-7 out of 10 on a numerical rating scale (NRS) to any of the sensory stimuli mentioned in inclusion criterion
  6. The area of sensory hypersensitivity can be up to a total of 600 cm2.
  7. 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:

  1. 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.
  2. A body mass index (BMI) <18.5 kg/m2 or >35 kg/m2.
  3. Serum aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) levels >2 times the upper limit of normal (ULN) at the screening assessments.
  4. 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.
  5. 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.
  6. Have a Hospital Anxiety and Depression Scale (HADS) score of 15 or above.
  7. Active Human immunodeficiency virus (HIV) or ongoing hepatitis B and/or C.
  8. Ongoing infection with fever (i.e., body temperature >38.0 ˚C).
  9. Known history of hypersensitivity to components of the study drug or a history of anaphylactic reactions.
  10. 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.
  11. History of dermatological diseases including rosacea, syphilitic and tuberculotic reactions.
  12. Open wounds, scars, as well as extended tattoos on intended treatment areas.
  13. Skin infections, acne, skin inflammation, eczema, or other dermatological disorders in the intended treatment area.
  14. Pregnant or breastfeeding female or female who is planning pregnancy during the study period.
  15. Could be negatively affected by participation in the study, as judged by the investigator.
  16. Diagnosed with any significant psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5® criteria, including drug abuse or dependency.
  17. Daily intake of opioids at a daily dose of more than 60 morphine equivalents.
  18. Use of Lidocaine patches within 7 days prior to randomisation until the follow-up visit.
  19. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACD440 Gel 14mg/g
Topically applied to painful neuropathic area twice daily for 7 days
Drug: ACD440 Gel 14mg/g
Topical application to painful area
Placebo Comparator: Placebo Gel
Topically applied to painful neuropathic area twice daily for 7 days
Drug: Placebo Gel
Topical application to painful area

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AlzeCure Pharma

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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