Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of the study is to determine the safety and the efficacy of Tretinoin and Pioglitazone HCL in patients with ALS who are currently on Riluzole.

Key facts

Study ID

NCT00919555

Run by

Phoenix Neurological Associates, LTD

People needed

28

Starts

2008-06-01

Expected to finish

2012-03-01

Last updated by the study team

2012-11-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• El Escorial Classification of laboratory supported probable, probable, or definite ALS
• Age 18 - 85 years
• Male or female
• FVC greater than or equal to 70% predicted

You may not qualify if…

• Patients with FVC below 1.5 L or below 70% predicted
• History of liver disease
• Severe renal failure (CrCl<30)
• History of coronary artery disease requiring placement of stents, bypass surgery or previous myocardial infarction
• EKG at baseline with evidence for previous myocardial infarction, cardiomyopathy, or arrhythmia
• History of intolerance to Riluzole, Tretinoin, or Pioglitazone HCL
• History of diabetes
• Any other comorbid condition which would make completion of trial unlikely

Where it is running

• Phoenix Neurological Associates, LTD — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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