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

NCT00498615 | Completed Phase 3 Results

• 1 other identifier: NA_00002801
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Raynaud; Scleroderma

Keywords

scleroderma; Raynaud's phenomenon; Rho-kinase inhibitor

Outcome Measures

Primary Outcomes (2)

• The Time to Recover 50% of Fall in the Baseline Skin Temperature.

  The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.

  within 60 minutes

• Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.

  The time to recover 70% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.

  within 60 minutes

Secondary Outcomes (1)

• The Blood Flow by Laser Doppler Scans of the Fingers

  Blood flow prior to cold challenge 2 hours after taking study drug

Study Arms (3)

Fasudil 80 mg

EXPERIMENTAL

Subject is given a single dose of 80 mg of Fasudil ( blinded to participant and researcher) a cold challenge is given 2 hrs after the dose.

Drug: Fasudil

40 mg Fasudil

EXPERIMENTAL

Subject is given a single dose of 40 mg of Fasudil ( blinded to participant and researcher) a cold challenge is given 2 hrs after the dose.

Drug: Fasudil

placebo

PLACEBO COMPARATOR

Subject is given a single dose of placebo( blinded to participant and researcher) a cold challenge is given 2 hrs after the dose.

Drug: Fasudil

Interventions

Fasudil DRUG

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 sequences. 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 24 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session.

Also known as: No other name found

40 mg Fasudil; Fasudil 80 mg; placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of scleroderma
• definite Raynaud's

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Raynaud Disease

Interventions

fasudil

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular

Results Point of Contact

• Title: Gwen Leatherman, R.N.
• Organization: Johns Hopkins University

gleathe@jhmi.edu

410-550-8582

Study Officials

• Fredrick M Wigley, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 10, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 4, 2014
• Results First Posted: November 4, 2014

Record last verified: 2014-08

Locations

US (1)