Clinical trial · Interventional
Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)
A Randomised Double-blind Placebo-controlled Trial of the Safety and Efficacy of Ethosuximide 250mg Capsules for the Management of Chemotherapy Induced Painful Peripheral Neuropathy
NCT01278004CI-TRIAL-00022383CINE-EcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. Ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethosuximide | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo capsule
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Drug
- interventionNames
- Drug: Ethosuximide
Primary outcomes (1)
- measure
- Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 * Diagnosis of cancer * 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 (translators will not be used) * Chemotherapy-induced painful peripheral neuropathy as diagnosed by 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). * Duration of chemotherapy-induced painful peripheral neuropathy \>4 weeks. Participant may either have completed chemotherapy, or be receiving ongoing chemotherapy. * Able to attend research centre according to the required visit schedule. * Diet allows bovine gelatine (present in both ethosuximide and placebo capsules) * 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. Exclusion Criteria: * Renal impairment (serum creatinine \>1.5x normal level) * Deranged liver function (AST\>3x normal level) * Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week. * Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week. * Pregnancy * Allergy to succinimides, ethosuximide, methsuximide, phensuximide. Pre-exisitng painful peripheral neuropathy of any other cause.
References
Publications (0)
Data not yet available
No reference posted for this study.