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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00035815 |
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Date of registration:
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06/05/2002 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
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Scientific title:
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Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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330 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00035815 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Puerto Rico
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United States
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Contacts
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Name:
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Eric Sorenson, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Mayo Clinic |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Placebo
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Drug: Insulin like growth factor, type 1
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Primary Outcome(s)
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Rate of Change in Composite Manual Muscle Testing (MMT) Score
[Time Frame: Baseline and 24 months]
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Secondary Outcome(s)
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Rate of Change in ALS Functional Rating Scale.
[Time Frame: Baseline and 24 months]
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Number of Participants Alive and Tracheostomy-free at 24 Months
[Time Frame: baseline to 24 months]
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Secondary ID(s)
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R01NS042759
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1461-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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