Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)

Phase 2

Completed

• Conditions: Cancer; Peripheral Neuropathy
• Interventions: Drug: Placebo; Drug: Ethosuximide

• Registration Number: NCT01278004
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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'.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule
Drug	Ethosuximide	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

The Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom