Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome

NCT02095899 | Withdrawn Phase 2 DMC

• 1 other identifier: 2013-253
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Nerve Injuries; Pain

Keywords

Thoracic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rufinamide

EXPERIMENTAL

\- oral Rufinamide administration as ad-on to Oxycodone

Drug: Rufinamide

Manitol

PLACEBO COMPARATOR

\- oral Placebo administration - as ad-on to Oxycodone

Drug: Rufinamide

Interventions

Rufinamide DRUG

2x200mg up to max 2x800mg a day Titration over 20days

Also known as: Inovelon

Manitol; Rufinamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Institut of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries; Pain

Interventions

rufinamide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Konrad Maurer, MD

  University Hospital Zurich, Institut of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

CH (1)