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

This study is currently recruiting participants.

Verified December 2011 by Royal Marsden NHS Foundation Trust

Sponsor:

Collaborator:

Imperial College London

Information provided by (Responsible Party):

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01278004

First received: January 13, 2011

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 13, 2011

Last Updated Date

December 7, 2011

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01278004 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Cancer
Peripheral Neuropathy

Intervention ^ICMJE

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

Study Arm (s)

Placebo Comparator: Placebo
Placebo capsule

Intervention: Drug: Placebo
Experimental: Drug
Intervention: Drug: Ethosuximide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Julia Riley

0207 80802761

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01278004

Other Study ID Numbers ^ICMJE

CCR3116

Has Data Monitoring Committee

Yes

Responsible Party

Royal Marsden NHS Foundation Trust

Study Sponsor ^ICMJE

Royal Marsden NHS Foundation Trust

Collaborators ^ICMJE

Imperial College London

Investigators ^ICMJE

Not Provided

Information Provided By

Royal Marsden NHS Foundation Trust

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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