E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic peripheral neuropathic pain caused by polyneuropathy, postherpetic neuralgia and traumatic/surgical nerve injury. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
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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 oxcarbazepine is more efficacious for relief of periperal neuropathic pain in patients with irritable nociceptor pain phenotype than in patients without this phenotype. |
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E.2.2 | Secondary objectives of the trial |
- to test effect of oxcarbazepine on different pain phenomena in peripheral neuropathic pain - to test if the effect of oxcarbazepine depends on presence of pain paraxysms - to test if the effect of oxcarbazepine depends on pain characteristics as determined by Neuropathic Pain Symptom Inventory - to test if the effect of oxcarbazepine depends sensory profile (quantitaive sensory testing) - to influence of patient expectations on effect of oxcarbazepine and placebo
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
125 patients aged 18 or more with peripheral neuropathic pain for at least 3 month with a pain intensity of at least 4 (0-10) due to polyneuropathy, postherpetic neuralgia or peripheral nerve injury (e.g. postsurgical). At baseline, patients undergo a quantitative sensory testing (QST) (defined in WP 4.3) and patients will be phenotyped with respect to quantitative sensory testing and subdivided into one group with pain suggested to be caused by irritable nociceptors (Nin), defined as preserved cold or warm sensation (detections thresholds within the 95% CI of the reference material and no relative abnormality) and hypersensitivity to touch, pinprick or thermal stimuli), the remainder without this phenotype. Thus, using the nomenclature from the German network, the Nin includes: L0G1, L0G1, L0G2, L0G3, L2G1, L2G2, L2G3 and Nnin all combinations with L1 and L3 and L0G0 and L2G0 (Maier et al. 2010).
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E.4 | Principal exclusion criteria |
Exclusion criteria include pregnancy or lactation, allergy to oxcarbazepine, past history of hypersensitivity to carbamazepine or oxcarbazepine, renal or severe hepatic impairment epilepsy, depression and psychiatric disorders. Concomitant medication for neuropathic pain is not allowed but previous treatments for neuropathic pain are not a contraindication. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary effect variable will be the change in pain intensity (0-10 NRS) from the baseline week to the last week of treatment (as recorded in diary). A responder is defined as a 50% reduction in pain score (from baseline week to last week of treatment) and response on active drug at least 2 times the reduction observed on placebo. Secondary effect variable will be 1) pain relief (complete, good, moderate, slight, none, or worse), 2) overall period preference, and 3) effect on brush evoked allodynia, cold allodynia, and pinprick hyperalgesia, 4) escape medication (paracetamol) The primary analysis of the study will be the difference in number of responders between Nin and Nnin and the median change in pain score in the total population and each of the two subgroups compared to placebo.
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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 | No |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | 2 |
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 | Information not present in EudraCT |
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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Trial will end when 100 patients have completed and at least 25 of these are patients with irritable nociceptor phenotype |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |