ACD440 Gel in Peripheral Neuropathic Pain

NCT05416931 | Completed Phase 2

• 1 other identifier: D8000-003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to Day 7

Secondary Outcomes (3)

• Symptoms of neuropathic pain

  Baseline and day 7 of the respective treatment period

• Intensity of spontaneous pain on a numerical rating scale (NRS)

  Baseline and day 7 of the respective treatment period

• Patient Global Impression of Change (PGIC)

  Day 7 of the respective treatment period

Other Outcomes (1)

• Safety and Tolerability

  From enrollment through study completion on Day 42.

Study Arms (2)

ACD440 Gel 14mg/g

EXPERIMENTAL

Topically applied to painful neuropathic area twice daily for 7 days

Drug: ACD440 Gel 14mg/g

Placebo Gel

PLACEBO COMPARATOR

Topically applied to painful neuropathic area twice daily for 7 days

Drug: Placebo Gel

Interventions

ACD440 Gel 14mg/g DRUG

Topical application to painful area

ACD440 Gel 14mg/g

Placebo Gel DRUG

Topical application to painful area

Placebo Gel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AlzeCure Pharma: lead

Study Sites (1)

Akademiska sjukhuset

Uppsala, 75185, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 14, 2022
• Study Start: June 20, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)