E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from localized neuropathic pain (LNP) |
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E.1.1.1 | Medical condition in easily understood language |
Patients suffering from localized neuropathic pain (LNP) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine if topical treatment with lidocaine 5% patch (daily administration) or capsaicin 8% patch (periodic administration – upon reoccurrence of pain symptoms) significantly improves health-related quality of life after 6 weeks of treatment compared to systemic (oral) treatment with pregabalin as standard of care in adult patients suffering from localized neuropathic pain across a wide variety of etiologies (LNP), with a duration between 1 and 12 months (subacute to chronic neuropathic pain).
We are interested in 3 comparisons, between on the one hand the systemic versus the topical treatment options (pregabalin versus capsaicin 8% patch, pregabalin versus lidocaine 5% patch), and on the other hand within the topical treatment options (capsaicin 8% patch versus lidocaine 5% patch - as they imply a considerable difference in cost).
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E.2.2 | Secondary objectives of the trial |
• To compare the quality of life profiles over the 24 weeks’ treatment period between the treatment arms.
• To compare the effectiveness in terms of pain relief between the treatment arms.
• To compare the effectiveness in different aspects of quality of life (sleep, mood) between the treatment arms.
• To compare the drug tolerance between systemic and topical treatment.
• To identify the difference between topical and systemic treatment in terms of functional status of the patient.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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; |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change in EQ-5D-5L between baseline and week 6.
EQ-5D-5L is a standardized instrument for use as a measure of health outcome, describing states of health in five dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression.
This endpoint is chosen to reflect efficacy (beneficial effect of the compared treatments).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at 6 weeks after treatment start |
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E.5.2 | Secondary end point(s) |
• Long term quality of life profile;
• Reduction in pain intensity (PI-NRS);
• Time to worsening of the pain and use of rescue medication for pain (MQS III-R);
• Global perceived effect (GPE);
• Effect on mood (Hospital Anxiety and Depression Scale);
• Quality of sleep (NRS and ISI);
• Percentage of patients without systemic drug related side effects (dizziness, fatigue, vertigo, somnolence, headache, blurred vision);
• Time to discontinuation of the study drug and proportion of patients stopping the drug;
• Participation in activities (Utrecht Work Engagement Scale-9);
• Impact of pain on functioning (interference – BPI);
• Work Productivity and Activity Impairment (WPAI: Neuropathic Pain, v2.2, Belgium);
• Neuropathic Pain Symptom Inventory (NPSI).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at 6 and 26 weeks after treatment start |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
A switch between treating arms is allowed in case of side effects (see protocol page 37 |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 21 |
E.8.9.1 | In the Member State concerned days | |