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)

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1

Lauren Krupp

Stony Brook, New York, United States, 117948121