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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer, Peripheral Neuropathy

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

6 weeks

Safety Issue:

No

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CCR3116

NCT ID:

NCT01278004

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Cancer
  • Peripheral Neuropathy
  • Adult cancer patients with chemotherapy-induced painful peripheral neuropathy
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

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