A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or toes. Patients often continue to experience problems despite current available treatment. The investigators' study will investigate the use of a new vasodilator called Fasudil, a Rho-kinase inhibitor. The investigators' hypothesis is that Fasudil will prevent vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold exposure and will therefore improve digital blood flow and skin temperature recovery time following cold challenge. These data will provide the rationale for a more elaborate clinical trials in real life situations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: 1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine; Fasudil

Criteria

Inclusion Criteria:

• diagnosis of scleroderma

• definite Raynaud's

Exclusion Criteria:

• symptomatic orthostatic hypotension

• evidence of current malignancy

• active ischemic digital ulcer and/or tissue gangrene

• history of sympathectomy at any time

• upper extremity deep vein thrombosis or lymphedema within 3 months of the study

• recent surgical procedure requiring general anesthesia

• current alcohol or illicit drug use

• use of any investigational drug within 30 days of the study sessions

• pregnancy or current breast feeding

• subjects felt by the investigators to active disease that would affect their ability to safely participate in the study.