Clinical trial: Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis (NCT00355576)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment