Clinical Trials for Lyme disease

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Lyme disease is grouped into the following categories:-

• View by trial name
• View by drugs used in Lyme disease clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Lyme disease:

• Evaluation of Lyme Disease: Clinical, Microbiological and Immunological Characteristics - This study is currently recruiting patients (Current: 23 Nov 2006)
• Evaluation, Treatment, and Follow-up of Patients With Lyme Disease - This study is currently recruiting patients (Current: 23 Nov 2006)
• Brain Imaging and Retreatment Study of Persistent Lyme Disease - This study has been completed (Current: 23 Nov 2006) - ceftriaxone
• Lyme Disease Prevention Program - This study has been completed (Current: 23 Nov 2006)
• Study and Treatment of Post Lyme Disease (STOP-LD) - This study has been completed (Current: 23 Nov 2006) - Antibiotics
• A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease - This study has been completed (Current: 23 Nov 2006) - ceftriaxone,doxycycline
• A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease - This study has been completed (Current: 23 Nov 2006) - ceftriaxone,doxycycline
• Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis - This study is currently recruiting patients (Current: 23 Nov 2006) - Ceftriaxone,Doxycycline
• Analysis of Lyme Disease Lesions - This study is currently recruiting patients (Current: 23 Nov 2006)

Drugs used in Clinical Trials for Lyme disease

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Lyme disease:

• Antibiotics - Study and Treatment of Post Lyme Disease (STOP-LD) - This study has been completed (Current: 23 Nov 2006)
• Ceftriaxone - A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease - This study has been completed (Current: 23 Nov 2006)
• Ceftriaxone - A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease - This study has been completed (Current: 23 Nov 2006)
• Ceftriaxone - Brain Imaging and Retreatment Study of Persistent Lyme Disease - This study has been completed (Current: 23 Nov 2006)
• Ceftriaxone - Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis - This study is currently recruiting patients (Current: 23 Nov 2006)
• Doxycycline - A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease - This study has been completed (Current: 23 Nov 2006)
• Doxycycline - A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease - This study has been completed (Current: 23 Nov 2006)
• Doxycycline - Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis - This study is currently recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov

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