Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, 28 Day, Three-arm, Parallel Group Study of A0001 in the Treatment of Subjects With Friedreich's Ataxia
Brief Summary: This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001 given twice daily for 28 days. Potential subjects will be screened first to determine eligibility, after which they will be randomized to receive either a high dose of A0001, a low dose of A0001 or placebo for 28 days.

Eligible subjects will return within 21 days of screening for the baseline visit and randomization to one of three potential treatments. The subjects will be required to take 3 capsules of study medication in the morning with a morning meal and 3 capsules of study medication at night with an evening meal for 28 days. Additional visits to the clinic are planned for Day 14 and Day 28, at which time a number of clinical and biochemical assessments will be done.


Options:
A: Inclusion criteria:

* Documented diagnosis of Friedreich's Ataxia (FRDA) with confirmed FRDA mutations
* Patients 8 - 17 years of age at baseline
* Patients with a body weight greater than 25 kg/55 lbs at baseline
* Patients able to walk at least 10 meters without accompanying person (ICARS Walking Capacities score ≤6) at screening and baseline
* Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the study medication
* Negative urine pregnancy test at screening and baseline (female patients of childbearing potential)

Exclusion criteria:

* Treatment with idebenone, Coenzyme Q10 or vitamin E (if taken at a dose 5 times above the daily requirement) within the past month
* Patients with International Cooperative Ataxia Rating Scale (ICARS) score of greater than 54 or less than 10 at screening
* Pregnancy and/or breast-feeding
* Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of Aspartate Aminotransferase (AST; also known as GOT), Alanine Aminotransferase (ALT; also known as GPT) or creatinine
* History of abuse of drugs or alcohol
* Participation in the previous (Phase II) study of idebenone at the National Institutes of Health (NIH)
* Participation in a trial of another investigational drug within the last 3 months
B: * INCLUSION CRITERIA:

Diagnosis of FA with confirmed FRDA mutations.

Age from nine up to but not over eighteen years.

Weight between 30 to 80 kilograms.

Ambulatory (assistance devices permitted).

Willing to participate in all aspects of trial design and follow-up.

All subjects agree and commit to the use of 2 reliable methods of birth control for the duration of the study if sexually active.

Neurologically symptomatic.

No exposure to idebenone, coenzyme Q10, or other dietary supplements for a period of at least one month before enrollment in the study.

EXCLUSION CRITERIA:

History of a hypersensitivity reaction to idebenone or coenzyme Q10.

Pregnant or lactating women. All women of child-bearing potential must have negative serum pregnancy prior to the medication phase of the study. If a minor has a positive pregnancy test, we will inform her but not inform her parents unless we are asked to by the minor.

Platelet count, white blood cell count or hemoglobin below the lower limit of normal.

Alkaline phosphatase, SGOT, or SGPT greater than 1.5 times the upper limit of normal. Bilirubin greater than 1.5 g/dl.

Creatinine greater than 1.5 times the upper limit of normal based upon the pediatric reference range provided by the testing laboratory.

Clinically significant medical disease that, in the judgment of the investigators, would expose the patient to undue risk of harm or prevent the patient from completing the study.
C: Inclusion Criteria:

* Primary diagnosis of Major Depressive Disorder with symptoms of depression present at least 1 month
* Psychotropic medications currently not being taken

Exclusion Criteria:

* Failure to respond in past 5 years to antidepressant therapy of adequate duration and dosing
* Diagnoses of following conditions or disorders within past 6 months: generalized anxiety, obsessive compulsive, panic, post stress, anorexia, bulimia, alcohol or substance abuse or social anxiety disorder
* Diagnoses current or past of the following conditions or disorders: schizophrenia, psychotic disorder, delieium, dememtia, amnestic cognitive disorder, bipolar
D: Inclusion Criteria:

* Individuals with genetically confirmed Friedreich's Ataxia (GAA or point mutation)
* Impaired Glucose Tolerance, measured by Oral GTT

Exclusion Criteria:

* Overt Diabetes Mellitus
* Presence of clinically significant cardiovascular disease

Answer: D