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CompletedNCT01278004CINE-EUpdated May 26, 2016

Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)

A Phase 2 interventional study of Ethosuximide and Placebo in Cancer and Peripheral Neuropathy, sponsored by Royal Marsden NHS Foundation Trust. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-26.

Sponsored by Royal Marsden NHS Foundation Trust · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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'.

02

Conditions studied

  • Cancer
  • Peripheral Neuropathy

Keywords

  • Adult cancer patients with chemotherapy-induced painful peripheral neuropathy
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 15 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo capsule

    Drug: Placebo

  • Experimental
    Drug

    Drug: Ethosuximide

Interventions

  • DrugEthosuximide

    Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.

  • DrugPlacebo

    Capsule

06

What researchers measure

Primary outcomes

  1. Reduction in pain intensity from baseline to endpoint as assessed on a Numerical Pain Rating scale.

    Time frame: 6 weeks

07

Study locations

2 sites
  • Royal Marsden NHS Foundation Trust
    Sutton, Surrey SM2 5PT, United Kingdom
  • The Royal Marsden NHS Foundation Trust
    London, SW3 6JJ, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01278004
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Imperial College London
Responsible party
Sponsor
First posted
Jan 17, 2011
Start date
May 2010
Primary completion
Jul 2014
Completion
Jul 2014
Last update
May 26, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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