E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The medicial condition under investigation is chemotherapy-induced painful peripheral neuropathy (CIPPN). CIPPN is a complication of several classes of chemotherapy agents e.g taxanes (paclitaxel, docetaxel), platinum compounds (carboplatin, cisplatin and oxaliplatin) and vinca alkaloids (vincristine and vinblastine). These agents are standardly used in the treatment of several common cancers for example, ovarian, breast, lung and colon cancer making CIPPN a common problem. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036109 |
E.1.2 | Term | Polyneuropathy due to drugs |
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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 |
A randomised double-blind placebo-controlled trial of the safety and efficacy of ethosuximide for the management of chemotherapy-induced painful peripheral neuropathy.
Primary outcome measure will be the reduction in average pain intensity from baseline to end-point as measure on a 0-10 numerical rating scale. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of ethosuximide on different neuropathic pain characteristics.
To assess the impact of ethosuximide on mood and quality of life
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria
1. Age ≥18 2. Diagnosis of cancer. 3. Willing and able to give informed consent to the CIN-E study and complete study questionnaires, this involves adequate understanding of written and spoken English 4. Chemotherapy-induced painful peripheral neuropathy as diagnosed by a score of ≥12 on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) with a pain intensity rating of ≥4, on a 11 point numeric rating scale (0 = no pain, 10 = worst possible pain). 5. Duration of chemotherapy-induced painful peripheral neuropathy ≥ 4 weeks. Participants may either have completed chemotherapy, or be receiving ongoing chemotherapy. 6. Able to attend research centre according to the required visit schedule. 7. Diet allows bovine gelatine (present in both ethosuximide and placebo capsules) 8. Women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence.
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E.4 | Principal exclusion criteria |
Exclusion Criteria
1. Renal impairment (serum creatinine >1.5x normal level) 2. Deranged liver function (AST>3x normal level). 3. Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week. 4. Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week. 5. Pregnancy. 6. Allergy to succinimides, ethosuximide, methsuximide, phensuximide. 7. Pre-existing painful peripheral neuropathy of any other cause.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome measure: reduction in pain intensity from baseline to end-point as measured by an 11-point Numerical Rating Scale (NRS) for the average pain felt in the hands and/or feet over the last 24hours, 0 = no pain and 10 = worse pain imaginable. |
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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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Yes |
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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The CIN-E study end date is defined as the last visit for the last patient in the CIN-E study. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |