Clinical trial: Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial (NCT00035815)

Eligibility criteria:
Inclusion Criteria

        Patients entering this study:

          -  Are between the ages of 18-80 years old.

          -  Legal residents of the United States or Canada.

          -  Have a history of a chronic onset of a progressive motor weakness of less than 24
             months duration.

          -  Fulfill El Escorial criteria of probable or definite ALS.

          -  If female, are surgically sterile, two years postmenopausal, or if of child-bearing
             potential, must be using a medically acceptable method of birth control and agree to
             continue use of this method for the duration of the study. Acceptable methods include
             a barrier method with spermicide, oral contraceptives (normal doses are acceptable;
             low dose oral contraceptives or contraceptive implants must be used with a barrier
             method), intrauterine device (IUD), or abstinence. Have a negative pregnancy test.

          -  Are able to comply with protocol requirements.

          -  Can provide written informed consent.

          -  Have a manual muscle testing score of less than 8.

          -  Have a forced vital capacity by pulmonary function testing *60% predicted.

        Exclusion Criteria:

        Patients entering this study will not:

          -  Have any of the following conditions:renal disease (Creatine > 2.0) or other active
             systemic disease

          -  Have any clinically significant abnormalities on the prestudy laboratory evaluation,
             physical examination, ECG, chest x-ray or ophthalmologic exam.

          -  Have any clinically significant medical condition (e.g., within six months of
             baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure)
             that, in the opinion of the investigator, would compromise the safety of patient.

          -  Have Type I or Type II diabetes.

          -  Have a history of cancer including melanoma with the exception of localized skin
             cancers (with no evidence of metastasis, significant invasion, or re-occurrence within
             three years of baseline) and carcinoma in-situ of the cervix (women only).

          -  Have used an investigational drug within 30 days of baseline visit.

          -  Have had a tracheostomy.

          -  Have a Beck's Depression Inventory score * 12.

          -  Have legal residency outside of the United States or Canada.

          -  Be pregnant or breast-feeding.
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.
Subject must be at most 80 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