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

Completed · Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT00035815

Run by

Mayo Clinic

People needed

330

Starts

2003-06-01

Expected to finish

2007-12-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic in Scottsdale — Scottsdale, Arizona, United States
• California Pacific Medical Center — San Francisco, California, United States
• Mayo Clinic in Jacksonville — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Mississippi — Jackson, Mississippi, United States
• Beth Israel Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania, Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Methodist Hospital — Houston, Texas, United States
• West Virginia University — Morgantown, West Virginia, United States
• Froedtert and Medical College Clinics — Milwaukee, Wisconsin, United States
• University of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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