Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Celecoxib, Creatine, Minocycline, Combination, Selection, ALS, Motor Neuron Disease
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Phoenix Neurological Associates
- UCLA
- University of California Irvine
- California Pacific Medical Center
- Mayo Clinic Florida
- Medical College of Georgia
- University of Illinois
- University of Kansas
- Mayo Clinic Rochester
- Washington University
- UMDNJ
- University of New Mexico
- Beth Israel
- Columbia University
- Duke University
- Oregon Health and Science University
- University of Pennsylvania
- UT Southwestern Medical Center
- University of Vermont
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Minocycline + Creatine
Celecoxib + Creatine
Minocycline 100 mg BID and Creatine 10 g BID
Celecoxib 400 mg BID and Creatine 10 g BID