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. - CIN-E study

Phase 1

• Conditions: The medicial condition under investigation is chemotherapy-induced painful peripheral neuropathy (CIPPN). CIPPN is a complication of several classes of chemotherapy agents e.g taxanes (paclitaxel, docetaxel), platinum compounds (carboplatin, cisplatin and oxaliplatin) and vinca alkaloids (vincristine and vinblastine). These agents are standardly used in the treatment of several common cancers for example, ovarian, breast, lung and colon cancer making CIPPN a common problem.; MedDRA version: 9.1 Level: LLT Classification code 10036109 Term: Polyneuropathy due to drugs

• Registration Number: EUCTR2008-004499-38-GB
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2014-07-09
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Inclusion criteria

1.Age =18
2.Diagnosis of cancer.
3.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
4.Chemotherapy-induced painful peripheral neuropathy as diagnosed by a 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).
5.Duration of chemotherapy-induced painful peripheral neuropathy = 4 weeks. Participants may either have completed chemotherapy, or be receiving ongoing chemotherapy.
6.Able to attend research centre according to the required visit schedule.
7.Diet allows bovine gelatine (present in both ethosuximide and placebo capsules)
8.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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria

1.Renal impairment (serum creatinine >1.5x normal level)
2.Deranged liver function (AST>3x normal level).
3.Patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week.
4.Patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week.
5.Pregnancy.
6.Allergy to succinimides, ethosuximide, methsuximide, phensuximide.
7.Pre-existing painful peripheral neuropathy of any other cause.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: A randomised double-blind placebo-controlled trial of the safety and efficacy of ethosuximide for the management of chemotherapy-induced painful peripheral neuropathy.<br><br> Primary outcome measure will be the reduction in average pain intensity from baseline to end-point as measure on a 0-10 numerical rating scale.<br> ;<br> Secondary Objective: To assess the effect of ethosuximide on different neuropathic pain characteristics.<br><br> To assess the impact of ethosuximide on mood and quality of life<br><br> ;Primary end point(s): Primary outcome measure: reduction in pain intensity from baseline to end-point as measured by an 11-point Numerical Rating Scale (NRS) for the average pain felt in the hands and/or feet over the last 24hours, 0 = no pain and 10 = worse pain imaginable.