Study and Treatment of Post Lyme Disease (STOP-LD) (NCT00000937) | Clinical Trial Compass
CompletedPhase 3
Study and Treatment of Post Lyme Disease (STOP-LD)
United States55 participants
Plain-language 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 Lyme Disease. When fatigue does not improve after treatment, patients are considered to have Post Lyme Syndrome (PLS). The chronic fatigue seen in these patients appears to be related to the initial infection which causes Lyme Disease. It is believed, but not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in PLS patients.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000937
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)