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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278004
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : May 26, 2016
Imperial College London
Information provided by (Responsible Party):
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'.

Condition or disease Intervention/treatment Phase
Cancer Peripheral Neuropathy Drug: Ethosuximide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Study Start Date : May 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo

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

Primary Outcome Measures :
  1. Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale. [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278004

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United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Imperial College London

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Responsible Party: Royal Marsden NHS Foundation Trust Identifier: NCT01278004     History of Changes
Other Study ID Numbers: CCR3116
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016

Keywords provided by Royal Marsden NHS Foundation Trust:
Adult cancer patients with chemotherapy-induced painful peripheral neuropathy

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases