Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS

Phase 4 Study of the Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With Chronic Fatigue Syndrome.

Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome
• Intervention / Treatment: Drug: Sildenafil (Viagra); Drug: Placebo

Detailed Description

Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90059
      • Charles Drew University of Medicine and Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients meeting the CDC definition of CFS.
• All races, ethnicities, socio-economic status (SES), and gender
• Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).
• Age less than 50. Because of concern of sildenafil exacerbating coronary artery disease, we will only enroll patients younger than 50.
• Able to provide informed consent.
• Willingness to be off all medicines and supplements for 3 weeks prior to the study.
• Patients with psychiatric disorders (see below) will be included, if they could be off their medications, and if their psychiatric diagnosis clearly occurred after their fatigue symptoms began.
• Patients with concurrent fibromyalgia will be allowed to participate if the meet diagnostic criteria for CFS.

Exclusion Criteria:

• Disabilities that would prevent them from participating in the study.
• Current use of prescription medicines (starting at 3 weeks prior to the study) and supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin. This includes herbal supplements and vitamins.
• Existing medical illnesses, such as heart disease, hypertension, cancer, rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure disorders, severe obesity (BMI > 32 kg/m2),
• Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and previous or current diagnosis of alcohol or substance abuse within the past year. Patients with depression of such severity as to warrant treatment with anti-depressants will be excluded.
• Current abuse of illicit drugs or heavy ethanol use.
• Pregnant women will be excluded because of radioactivity exposure from the SPECT scans.
• Abnormal EKG
• Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR tests.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; Placebo pills 3X/day for 6 weeks
Experimental: sidenafil	Drug: Sildenafil (Viagra); 25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue Impact Scale at 6 Weeks	change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated	6 weeks

Collaborators and Investigators

• Sponsor: Charles Drew University of Medicine and Science
• Collaborators: Pfizer
• Investigators: Principal Investigator: Ted C Friedman, M.D., Ph.D., Charles Drew University of Medicine and Science

Publications and helpful links

Helpful Links

• Clinical Trial Research site

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 31, 2005
• First Submitted That Met QC Criteria: January 21, 2008
• First Posted (Estimate): January 22, 2008

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: 02-04-378-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No