Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix Neurological Associates, LTD
• Treatments: Pioglitazone; Tretinoin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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