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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278004

Acronym

CINE-E

Enrollment

Registered

2011-01-17

Start date

2010-05-31

Completion date

2014-07-31

Last updated

2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Peripheral Neuropathy

Keywords

Adult cancer patients with chemotherapy-induced painful peripheral neuropathy

Brief summary

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'.

Interventions

DRUGEthosuximide

Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.

DRUGPlacebo

Capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.	6 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026