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Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study) (CINE-E)
This study has been completed.
Sponsor:
Royal Marsden NHS Foundation Trust
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: May 25, 2016
Last verified: May 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Cancer Peripheral Neuropathy | Drug: Ethosuximide Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
MedlinePlus related topics:
Peripheral Nerve Disorders
Drug Information available for:
Ethosuximide
U.S. FDA Resources
Further study details as provided by Royal Marsden NHS Foundation Trust:
Primary Outcome Measures:
- Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale. [ Time Frame: 6 weeks ]
| Enrollment: | 15 |
| Study Start Date: | May 2010 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278004
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01278004 History of Changes |
| Other Study ID Numbers: |
CCR3116 |
| Study First Received: | January 13, 2011 |
| Last Updated: | May 25, 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 |
ClinicalTrials.gov processed this record on July 21, 2017