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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place at approximately 6-month intervals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: ALS Association; Cephalon; National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Insulin; Insulin, Globin Zinc; Mitogens

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.