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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-07-31

Brief Summary

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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'.

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Detailed Description

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Conditions

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Cancer Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule

Drug

Group Type EXPERIMENTAL

Ethosuximide

Intervention Type DRUG

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

Interventions

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Ethosuximide

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

Intervention Type DRUG

Placebo

Capsule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No