Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Insulin like growth factor, type 1; Placebo
Intervention description: 0.05 mg per kg body weight given subcutaneously twice daily; The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.
Intervention MeSH terms: Mitogens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: amyotrophic lateral sclerosis; ALS; progressive weakness; insulin-like growth factor-1; IGF-I; Myotrophin

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.
    

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.