Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial

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 24months duration.

• Fulfill El Escorial criteria of probable or definite ALS.

• If female, are surgically sterile, two years postmenopausal, or if of child-bearingpotential, must be using a medically acceptable method of birth control and agree tocontinue use of this method for the duration of the study. Acceptable methods includea barrier method with spermicide, oral contraceptives (normal doses are acceptable;low dose oral contraceptives or contraceptive implants must be used with a barriermethod), 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 activesystemic 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 ofbaseline, 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 skincancers (with no evidence of metastasis, significant invasion, or re-occurrence withinthree 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.