Clinical Trials for Mitochondrial diseases

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 Mitochondrial diseases is grouped into the following categories:-

• View by trial name
• View by drugs used in Mitochondrial diseases 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 Mitochondrial diseases:

• RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease - This study has been terminated (Current: 23 Nov 2006) - RG2133 (2',3',5'-tri-O-acetyluridine)
• Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006) - Dichloroacetate
• Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia - This study is currently recruiting patients (Current: 23 Nov 2006)
• Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy - This study has been completed (Current: 23 Nov 2006) - thioctic acid
• Safety Study of Idebenone to Treat Friedreich's Ataxia - This study has been completed (Current: 23 Nov 2006) - Idebenone
• Transitional Life Events in Patients With Friedreich's Ataxia: Implications for Genetic Counseling - This study has been completed (Current: 23 Nov 2006)
• Phase 1 Trial of Idebenone to Treat Patients With Friedreich's Ataxia - This study has been completed (Current: 23 Nov 2006) - Idebenone
• Iron-Chelating Therapy and Friedreich Ataxia - This study is currently recruiting patients (Current: 23 Nov 2006) - Iron chelating intervention
• Idebenone to Treat Friedreich's Ataxia - This study is no longer recruiting patients (Current: 23 Nov 2006) - Idebenone
• Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia - This study is currently recruiting patients (Current: 23 Nov 2006)
• Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy - This study has been completed (Current: 23 Nov 2006) - thioctic acid
• Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006) - Dichloroacetate

Drugs used in Clinical Trials for Mitochondrial diseases

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 Mitochondrial diseases:

• Dichloroacetate - Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Idebenone - Idebenone to Treat Friedreich's Ataxia - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Idebenone - Phase 1 Trial of Idebenone to Treat Patients With Friedreich's Ataxia - This study has been completed (Current: 23 Nov 2006)
• Idebenone - Safety Study of Idebenone to Treat Friedreich's Ataxia - This study has been completed (Current: 23 Nov 2006)
• Iron chelating intervention - Iron-Chelating Therapy and Friedreich Ataxia - This study is currently recruiting patients (Current: 23 Nov 2006)
• RG2133 (2',3',5'-tri-O-acetyluridine) - RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease - This study has been terminated (Current: 23 Nov 2006)
• Thioctic Acid - Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy - This study has been completed (Current: 23 Nov 2006)
• Dichloroacetate - Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Thioctic Acid - Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy - This study has been completed (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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