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

Purpose

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.

Condition	Intervention	Phase
Raynaud Scleroderma	Drug: Fasudil	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

Resource links provided by NLM:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Scleroderma

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

The time to recover 50% and 70% of fall in the baseline skin temperature. [ Time Frame: Within 60 minutes following cold challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The blood flow profile changes as determined by Laser Doppler scans of the fingers [ Time Frame: Within the time frame of the cold challenge recovery period ] [ Designated as safety issue: No ]

Enrollment:	17
Study Start Date:	April 2007
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498615

Locations

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Fredrick M Wigley, M.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Fredrick M. Wigley, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00498615 History of Changes
Other Study ID Numbers:	NA_00002801
Study First Received:	July 6, 2007
Last Updated:	March 29, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

scleroderma
Raynaud's phenomenon
Rho-kinase inhibitor

Additional relevant MeSH terms:

Scleroderma, Systemic
Scleroderma, Diffuse
Raynaud Disease
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Fasudil

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013