Flecainide in Treating Patients With Chronic Neuropathic Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002996
• Other study ID #: CDR0000065544
• Secondary ID: E1Z95
• Status: Completed
• Phase: Phase 2
• Start date: May 4, 1998

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Drug:
• flecainide acetate

Locations

Country	Name	City	State
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

von Gunten CF, Eappen S, Cleary JF, Taylor SG 4th, Moots P, Regevik N, Cleeland C, Cella D. Flecainide for the treatment of chronic neuropathic pain: a Phase II trial. Palliat Med. 2007 Dec;21(8):667-72. doi: 10.1177/0269216307083031. — View Citation