- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278004
Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study) (CINE-E)
May 25, 2016 updated by: Royal Marsden NHS Foundation Trust
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
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'.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
-
-
Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Royal Marsden NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo capsule
|
Capsule
|
Experimental: Drug
|
Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
January 13, 2011
First Submitted That Met QC Criteria
January 14, 2011
First Posted (Estimate)
January 17, 2011
Study Record Updates
Last Update Posted (Estimate)
May 26, 2016
Last Update Submitted That Met QC Criteria
May 25, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR3116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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