Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome (RUFPTPS)

Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.

The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Peripheral Nerve Injuries
• Intervention / Treatment: Drug: Rufinamide

Detailed Description

Patients with chronic neuropathic pain after thoracic surgery will be evaluated and treated with oxycodone. Patients with a stable analgesic regimen, not reaching a good pain relief will be randomized to receive Rufinamide (Inovelon)vs. Placebo as an ad-on treatment to oxycodone. Neurophysiological and clinical data will be monitored.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Institut of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria, Run-In Phase:

• Age: 18-75 years
• Weight: 50 - 100kg
• Height: 155 - 195cm
• Sufficient command of German language
• Patient after thoracotomy
• Pain duration of more than 6 month.
• Diagnosis of Neuropathic Pain (DN4 questionnaire)
• Average baseline mean last week pain intensity =5 on NRS (numerical rating scale)
• Signed and dated informed consent

Inclusion criteria, Treatment Phase:

• Stable analgesic regimen for at least 7 days prior to randomisation
• Patients not reaching a NRS = 3 (numeric rating scale) with the baseline individually dose adjusted treatment (oxycodone).

Exclusion criteria:

• Contraindications to the class of drugs under study, e.g. (rufinamide, oxycodone) known hypersensitivity or allergy this class of drugs
• Hypersensitivity to triazole derivates - antifungal drugs including: fluconazole (e.g. Diflucan®), posaconazole (Noxafil®), itraconazole (Sporanox®), voriconazole (Vfend®)
• Lactose intolerance, galactosemia or galactokinase deficiency, glucose-galactose malabsorption
• Use of topical analgesics, or nerve block of the affected or adjacent dermatomes (less than to 2 weeks prior to the therapy onset visit or during the study period)
• Women who are pregnant or breast feeding; intention to become pregnant during the course of the study, lack of safe contraception, defined as: female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not willing or able to use any other second (additional) considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, severe cardiovascular disease, etc)
• Creatinine clearance = 30 ml/min (estimated from serum creatinine using the Cockcroft - Gault formula) were excluded
• Known drug (opiate or other) or alcohol abuse
• Contraindication to the use of oxycodone
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
• Participation in another study with investigational drugs within the 30 days preceding and during the present study
• Enrollment of the investigators, his/her family members, employees and other dependent persons
• Known neurological disease with peripheral manifestations including neuropathy associated with disease such as diabetes
• Known sensory changes from other medical conditions (e.g. infections affecting the investigation areas, post-herpetic neuralgia)
• Epilepsy
• Abnormal electrocardiogram (especially Familial Short QT syndrome)
• Patient having another pain condition with greater pain intensity
• Repeated thoracic surgeries
• Pneumonectomy or chest wall resection
• Bilateral thoracic surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rufinamide; - oral Rufinamide administration as ad-on to Oxycodone	Drug: Rufinamide; 2x200mg up to max 2x800mg a day Titration over 20days; Other Names: Inovelon
Placebo Comparator: Manitol; - oral Placebo administration - as ad-on to Oxycodone	Drug: Rufinamide; 2x200mg up to max 2x800mg a day Titration over 20days; Other Names: Inovelon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area of punctuate hyperalgesia immediately after topical capsaicin.	The primary variable to test is the area of punctuate hyperalgesia after topical capsaicin application in patients treated with rufinamide versus placebo.	2h after capsaicin removal

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Konrad Maurer, MD, University Hospital Zurich, Institut of Anaesthesiology

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Thoracic Surgical Procedures
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Rufinamide
• Other Study ID Numbers: 2013-253