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

Cancer Clinical Trial

— CINE-E  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278004
• Other study ID #: CCR3116
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2011
• Last updated: May 25, 2016
• Start date: May 2010
• Est. completion date: July 2014

Study information

• Verified date: May 2016
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cancer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.		6 weeks	No