Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00919555 |
Date of registration:
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08/06/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)
PNA |
Scientific title:
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Phase IIA Trial: Tretinoin and Pioglitazone HCL Combination Therapy in Amyotrophic Lateral Sclerosis |
Date of first enrolment:
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June 2008 |
Target sample size:
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28 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00919555 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Todd D Levine, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Neurological Associates, LTD |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Placebo
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Drug: Pioglitazone and Tretinoin
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Drug: Tretinoin and Pioglitazone HCL
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Primary Outcome(s)
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To evaluate the safety and efficacy of Tretinoin and Pioglitazone HCL in patients with ALS
[Time Frame: 3 years]
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Secondary Outcome(s)
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To determine if cerebrospinal fluid tau levels decline over the course of treatment and if the level of tau decline correlates with response in treatment measured by ALSFRS
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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