A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pai

Phase 2

Recruiting

• Conditions: europathic Pain; Neuropathic Pain; Neurological - Other neurological disorders

• Registration Number: ACTRN12617000206325
• Lead Sponsor: RR MedSciences Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-08
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1, Male/female patient aged 18 years or older, with moderate to severe neuropathic pain present for at least 3 months.
2. Affected area is appropriate for topical treatment.
3. Skin is intact over the area to be treated.
4. Pain must be due to neuropathic pain that, in the opinion of the Investigator, is of an appropriate severity for treatment.
5. Patient must have appropriate NPRS average pain over the last 24 hours for at least 3 of the 7 days prior to the Baseline Visit.
6. Prior pain medications expected to be continued at current level for the duration of the study.

Exclusion Criteria

1. Significant pain due to causes other than neuropathic pain.
2. Any history of a dermatological condition or recurrent generalized skin disorder in the area to be treated within last 5 years, inclduing psoriasis, eczema or any other skin condition that might interfere with study assessments.
3. Change in dose of long acting opioids or adjuvant analgesic medications within 7 days of the screening visit, during the screening period prior to baseline assessment of pain and/or during the study.
4. Current or recent use of any topically applied non-opioid pain medications on the painful areas within 3 days prior to Baseline assessment of pain and during the study.
5. Known allergy to copper.
6. Known diagnosis of WIlson's Disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Neuropathic Pain Intensity as assessed by Numeric Pain Rating Scale (NPRS)[Baseline, Day 1, Day 3, Day 8 (End of Washout), Day 9, Day 11]

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of topical RM191A spray by careful monitoring of following safety parameters: 1. Skin irritation 2. Adverse events 3. Evaluation of any medically significant changes, based on neurological and physical examination findings 4. Clinical laboratory testing with abnormal results[Baseline, Day 3, Day 5, Day 9, Day 11, Day 13, Day 17 (End of Study Visit)]