Status:
COMPLETED
Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Phoenix Neurological Associates, LTD
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Physicians at Phoenix Neurological Associates (PNA) are looking for individuals diagnosed with ALS to participate in a double-blind, placebo controlled study of Tretinoin and Pioglitazone HCL, used in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00919555
Start Date
June 1 2008
End Date
March 1 2012
Last Update
November 30 2012
Active Locations (1)
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1
Phoenix Neurological Associates, LTD
Phoenix, Arizona, United States, 85018