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

NCT01278004 | Completed Phase 2 DMC

• 1 other identifier: CCR3116
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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'.

Conditions

Cancer; Peripheral Neuropathy

Keywords

Adult cancer patients with chemotherapy-induced painful peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo

Drug

EXPERIMENTAL

Drug: Ethosuximide

Interventions

Ethosuximide DRUG

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

Drug

Placebo DRUG

Capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Imperial College London: collaborator

Study Sites (2)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Peripheral Nervous System Diseases

Interventions

Ethosuximide

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Succinimides; Imides; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: May 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 26, 2016

Record last verified: 2016-05

Locations

GB (2)