Clinical trial: Minocycline to Treat Amyotrophic Lateral Sclerosis (NCT00047723)

Eligibility criteria:
To be eligible for enrollment in this study, subjects must meet the following eligibility
        criteria within fourteen days prior to randomization:

        Inclusion criteria:

          -  A clinical diagnosis of laboratory-supported probable, probable or definite ALS,
             according to modified EL Escorial criteria.

          -  FVC greater or equal to 75% of predicted.

          -  Onset of weakness within 3 years prior to enrollment.

          -  If patients are receiving riluzole they must be on a stable dose for at least the past
             thirty days.

          -  Women of childbearing age must be non-lactating and surgically sterile or using an
             effective method of birth control and have a negative pregnancy test (adequate birth
             control includes use of intra-uterine device or oral contraceptives plus a barrier
             method, e.g. condom, diaphragm).

          -  Willing and able to give signed informed consent that has been approved by your
             Institutional Review Board (IRB).

        Exclusion criteria:

          -  Requirement for tracheotomy ventilation (or non-invasive ventilation > 23 hours/day).

          -  Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's
             disease, etc).

          -  FVC < 75% of predicted.

          -  A clinically significant history of unstable medical illness (unstable angina,
             advanced cancer, etc) over the last 30 days.

          -  History of renal disease (screening creatinine greater than 1.5).

          -  History of liver disease (screening alanine aminotransferase greater than 3 times the
             upper limit of normal).

          -  History of hematologic disease (screening white blood cell count less than 3,800/mm3).

          -  History of system lupus erythematosis (or screening ANA of 1:160 or greater).

          -  Treatment with any medications that may cause lupus-like symptoms within 4 weeks of
             baseline visit (e.g. procainamide, hydralazine).

          -  History of vestibular disease (excluding benign position vertigo).

          -  Pregnancy or lactation.

          -  Allergy to tetracycline antibiotics.

          -  Use of minocycline within thirty days of enrollment (baseline visit).

          -  Use of anti-epileptic medications other than gabapentin.

          -  Limited mental capacity rendering the subject unable to provide written informed
             consent or comply with evaluation procedures.

          -  History of recent alcohol or drug abuse or noncompliance with treatment or other
             experimental protocols.

          -  Use of any investigational drug within the past 30 days (Creatine, Vioxx, Celebrex,
             Topiramate).

          -  Women with the potential to become pregnant who are not practicing effective birth
             control.
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