Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 for ALS.

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

Details

• Lead Sponsor: Columbia University
• Collaborators: ALS Association; Pfizer
• Treatments: Celecoxib; Minocycline

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.