NCT01278004: CINE-E

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

Completed Phase 2 Last updated 25 May 2016

What this trial tests

Phase 2 trial testing Ethosuximide in Cancer in 15 participants. Completed in 1 July 2014.

Timeline

1 May 2010

Primary endpoint
1 July 2014

1 July 2014

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	15
Start date	1 May 2010
Primary completion	1 July 2014
Estimated completion	1 July 2014
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Ethosuximide (Ethosuximide) — full drug profile →
• Placebo

Conditions studied

• Cancer — all drugs for Cancer →
• Peripheral Neuropathy — all drugs for Peripheral Neuropathy →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, any sex, with Cancer or Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.
  Time frame: 6 weeks

Sponsor's own description

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'.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacological Treatment of Chemotherapy-Induced Neuropathic Pain: PPARγ Agonists as a Promising Tool.
   Quintão NLM, Santin JR, Stoeberl LC, Corrêa TP, et al · · 2019 · cited 59× · PMID 31555078 · DOI 10.3389/fnins.2019.00907