Skip to main content
OpenTrials
Completed

NCT Number: NCT00002996

Flecainide in Treating Patients With Chronic Neuropathic Pain

RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.

PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

Loading trial locations.

About this study

OBJECTIVES:

  • Investigate the effectiveness of flecainide in the management of neuropathic pain.

OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon enrollment in the study. Following a 7 day stabilization period, flecainide is administered. One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are completed on days 8, 15 and 22 to assess neuropathic pain.

PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Chronic neuropathic pain with diagnosis of cancer or AIDS

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • SGOT no greater than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 2 times ULN

Cardiovascular:

  • No clinical history of infarction or angina
  • No advanced heart failure
  • No sick sinus syndrome, intraventricular conduction disease, second or third degree AV block or arrhythmias requiring treatment (exception may be granted by cardiac consult)
  • No focal wall motion abnormalities
  • Ejection fraction at least 40%
  • Systolic blood pressure at least 90 mm Hg

Other:

  • Must be able to take oral medication
  • No known allergy or adverse reaction to flecainide, mexilitene or any other type I antiarrhythmic drug
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 2 weeks since prior chemotherapy that may cause neuropathy

Endocrine therapy:

  • At least 2 weeks since prior corticosteroids

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No tricyclic antidepressant treatment within past 2 weeks
  • No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug

Treatment and study plan

flecainide acetate

Drug

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial

Important dates

Study start
1998
Primary completion
2006
First posted
Jan 27, 2003
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.