ocalized neuropathic pain: topical treatment versus systemic treatment

Phase 1

• Conditions: Patients suffering from localized neuropathic pain (LNP); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-003617-17-BE
• Lead Sponsor: Antwerp University Hospital (UZA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-02
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 591

Inclusion Criteria

Patients eligible for inclusion in this study must fulfil all of the following criteria:

-Subjects should be capable of giving their informed consent with sufficient knowledge of the Dutch, French or German language;
-Males and females, 18 years and older;
-Be assessed as suffering from moderate to severe neuropathic pain across the screening process with pain intensity (numeric rating scale – NRS) = 4/10,
-At the time of screening pain symptoms have to be present for at least one (1) month, with a maximum of 24 months;
-Sensory disturbances present in the skin area of maximal pain;
-At the time of screening pain is clearly related to the presence of a localized neuropathic pain syndrome.
-Male or female patients of child producing potential must agree to use contraception or take measures to avoid pregnancy during the study and until after the final treatment;
-Women can only be included after negative pregnancy test;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 91

Exclusion Criteria

-Age < 18;
-Pregnant and breastfeeding women;

-Infection in the painful skin region;

-Poorly healed or non-healed wound or scar in the painful skin region as well as presence of cutaneous abnormalities (non-intact skin barrier) within the painful skin region related to dermatological conditions;
-Known and/or strong suspicion of allergy to the study medication, known skin disorder (resulting in disruption of the normal skin barrier);
-Previous treatment with any of the three medications included in the study protocol for the same painful area within the last 12 months at the time of screening;
-Risk of heart failure, renal failure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified