Status:
COMPLETED
Study and Treatment of Post Lyme Disease (STOP-LD)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Lyme Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to see how well antibiotics work in reducing chronic fatigue symptoms, such as tiredness, in patients that were treated for Lyme Disease. Fatigue is a common symptom of Ly...
Detailed Description
You will be assigned randomly (like tossing a coin) to receive either antibiotics or a placebo (sugar pill). Neither you nor your doctor will know which you are receiving. You will learn to give yours...
Eligibility Criteria
Inclusion Criteria:
You may be eligible for this study if you:
- Are between 18 and 65 years of age.
- Are a resident of Long Island or greater NY metropolitan area.
- Are fluent in English.
- Have a history of Lyme Disease.
- Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study.
- Have severe fatigue.
- Are not pregnant or planning to be pregnant.
Exclusion Criteria:
You will not be eligible for this study if you:
- Have or have had major medical, neurologic, or psychiatric disorder.
- Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease.
- Have had Fibromyalgia Syndrome.
- Have a history of sleep apnea, narcolepsy, or other serious sleep disorder.
- Have a learning disability.
- Have had head trauma requiring hospitalization.
- Have symptomatic gallbladder disease.
- Are anemic.
- Abuse alcohol or illicit drugs.
- Have been treated with another antimicrobial agent for Lyme Disease within 6 months of study.
- Need to be receiving systemic steroid therapy during drug administration and follow-up.
- Have used benzodiazepines within 1 month of study entry.
- Are allergic to Beta lactams (a class of antibiotics).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00000937
End Date
November 1 2005
Last Update
August 27 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lauren Krupp
Stony Brook, New York, United States, 117948121