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

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.

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
United Kingdom | |
Royal Marsden NHS Foundation Trust | |
Sutton, Surrey, United Kingdom, SM2 5PT | |
The Royal Marsden NHS Foundation Trust | |
London, United Kingdom, SW3 6JJ |
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 |