Status:
COMPLETED
Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Columbia University
Collaborating Sponsors:
ALS Association
Pfizer
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-85 years
Phase:
PHASE2
Brief Summary
The objective of this study is to compare two combinations of drugs, minocycline and creatine or celecoxib and creatine, in a phase II trial designed to determine which combination is more effective f...
Detailed Description
Excess free radicals, energy mishandling, excitotoxicity, activation of cell death pathways and inflammation likely all contribute to neurodegeneration in ALS. Past trials may have been negative in pa...
Eligibility Criteria
Inclusion
- A clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS, according to modified EL Escorial criteria
- FVC greater or equal to 60% at the screening visit
- Symptom onset within 5 years
- 21 to 85 years of age
- If patients are taking riluzole, they must be on a stable dose for at least the past thirty days
- A woman of childbearing age, must be nonlactating and surgically sterile or using an effective method of birth control (barrier method) and have a negative pregnancy test
- Able to maintain adequate hydration levels defined as 6-8 cups (8ounces/cup) of water or a non-caffeinated beverage per day
- Willing and able to give signed informed consent that has been approved by an Institutional Review Board (IRB)
Exclusion
- Tracheotomy and mechanical ventilation
- Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, etc)
- Unstable medical illness (coronary artery disease, advanced cancer, active esophageal or gastroduodenal ulcers, etc) in the last one year
- Systemic Lupus Erythematosis
- FVC \< 60%
- Pregnancy or lactation
- Allergy to minocycline, tetracyclines, celecoxib, sulfonamides, NSAIDS, or creatine
- History of congestive heart failure
- Renal disease \[baseline Cr \> 1.5 (men) or 1.2 (women)\]
- History of significant hepatic disease (baseline AST/ALT or bilirubin \> 1.5x normal)
- Use of an investigational agent within thirty days of enrollment
- First degree relative with ALS or gene identified familial ALS
- Inability or unwillingness to maintain adequate daily hydration (defined above)
- Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
- History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00355576
Start Date
July 1 2006
End Date
May 1 2007
Last Update
February 1 2011
Active Locations (19)
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1
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85006
2
UCLA
Los Angeles, California, United States, 90095
3
University of California Irvine
Orange, California, United States, 92868
4
California Pacific Medical Center
San Francisco, California, United States, 94115