Clinical trial: Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (NCT00690118)

Eligibility criteria:
Inclusion Criteria:

          -  possible, probable (clinically or laboratory) or definite ALS according to the revised
             version of the El Escorial World Federation of Neurology criteria

          -  disease duration more than 6 months and less than 3 years

          -  best-sitting FVC between 50% and 95% of predicted normal

          -  continuously treated with 100 mg riluzole daily, for at least one month

          -  onset of progression weakness within 36 months prior to study

          -  women of childbearing age be non-lactating and surgically sterile or using a highly
             effective method of birth control and have a negative pregnancy test

          -  capable of thoroughly understanding all information given and giving full informed
             consent according to GCP

        Exclusion Criteria:

          -  previous participation in another clinical study within the preceding three months

          -  tracheotomy or assisted ventilation of any type during the preceding three months

          -  gastrostomy

          -  any medical condition known to have an association with motor neuron dysfunction which
             might confound or obscure the diagnosis of ALS

          -  presence of any concomitant life-threatening disease or impairment likely to interfere
             with functional assessment

          -  confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT more than
             1.5 upper limit of normal)

          -  renal insufficiency (serum creatinine more than 2.26 mg/dl)

          -  evidence of major psychiatric disorder or clinically evident dementia precluding
             evaluation of symptoms

          -  known hypersensitivity to any component of the study drugs

          -  likely to be not cooperative or comply with the trial requirements (as assessed by the
             investigator), or unable to be reached in the case of an emergency

          -  other antidiabetics

          -  heart failure or heart failure in the patients history (NYHA I to IV)

          -  history of macular oedema

          -  treatment with thiazolidinediones within 3 months prior to screening

          -  known or suspected history of alcohol and/or drug abuse

          -  treatment with gemfibrozil within 3 months prior to screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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