E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peripheral neuropathic , i.e. painful polyneuropathy, postherpetic neuralgia and pain after nerve injury (traumatic or surgical). |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10077974 |
E.1.2 | Term | Peripheral neuropathic pain |
E.1.2 | System Organ Class | 100000004852 |
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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 |
The objective is to determine if bupropion relieves peripheral neuropathic pain |
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E.2.2 | Secondary objectives of the trial |
To determine if the potential effect of bupropion in peripheral neuropathic pain depends on function of conditioned pain modulation or sensory phenotype. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age over 18 years
- peripheral neuropathic pain for more than 3 months
- pain score at least 4 and not higher than 9 on a numeric rating scale 0-10 points
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E.4 | Principal exclusion criteria |
- other significant pain that cannot be distinguised from the peripheral neuropathic pain
- significantly reduced liver and kidney function
- epilepsy or recurrent seizures
- known lowered seizure threshold or significant risk factors for seizures
- major depressive episode within 6 months or other significant psychiatric diseases including alcohol or drug abuse
- Important drug interactions (e.g. treatment with levo-dopa, amantadin, MAO-inhibitors, flecainide, risperidine, thioridazine)
- pregnancy or lactation
- known allergy to bupropion or exipients
- concomittant pain treatment with TCAs, SNRIs, opioids, topical analgesics (lidocaine, capsaicin) and cannabinoids |
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E.5 End points |
E.5.1 | Primary end point(s) |
Week average of pain scored daily with numeric rating scale (NRS) 0 (no pain) to 10 (worst imaginable pain) points. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week average of NRS pain scores from the baseline periods and treatment periods week 1 to 6 are used in the general linear statistical model. |
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E.5.2 | Secondary end point(s) |
- Patient Global Impression of Change (PGIC, -3 to +3 points)
- Rating of pain relief as: complete, good, moderate, mild, none, worse
- Neuropathic pain symptom inventory (NPSI)
- Patient-Reported Outcome Measurement Information System (PROMIS)
- Columbia Suicide Severity Rating Scale (C-SSRS)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
PGIC and pain relief is evaluated at the end of the treatment periods (week 6).
NPSI, PROMIS and C-SSRS is evaluated in the baseline periods and at the end of the treatment periods (week 6). |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Subjects and observers are blinded to function of conditioned pain modulation and sensory phenotype |
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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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |