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

Chronic Fatigue Syndrome Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00598585
• Other study ID #: 02-04-378-07
• Status: Recruiting
• Phase: Phase 4
• First received: August 31, 2005
• Last updated: February 23, 2009
• Start date: July 2002
• Est. completion date: December 2010

Study information

• Verified date: February 2009
• Source: Charles Drew University of Medicine and Science
• Contact: Erik Zuckerbraun, M.D.
• Phone: 310.668.8754
• Email: erikzuckerbraun[@]cdrewu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Drug:
• Sildenafil (Viagra)
25 mg tid of either Sildenafil(Viagra) or Placebo for first week. 50 mg tid of either Sildenafil (Viagra)or Placebo for second week. 100 mg tid of either Sildenafil (Viagra)or Placebo for 3rd,4th, 5th and 6th week of study participation.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Charles Drew University of Medicine and Science	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The principal aim of this study is to determine whether chronic fatigue syndrome (CFS) is due to inadequate blood flow to the brain and to test a medication, Viagra, which should help increase blood flow to the brain and improve the symptoms of CFS.		6 weeks	Yes

External Links

•   Clinical Trial Research site