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

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ClinicalTrials.gov Identifier: NCT01278004
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : May 26, 2016
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Study Description
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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

Study Design
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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

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule
 Drug: Placebo
Capsule
Experimental: Drug Drug: Ethosuximide
Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.


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

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

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01278004


Locations
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov 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:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Ethosuximide
Anticonvulsants