Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
2 other identifiers
interventional
330
2 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2003
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2002
CompletedFirst Posted
Study publicly available on registry
May 7, 2002
CompletedStudy Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
February 15, 2013
CompletedFebruary 15, 2013
February 1, 2013
4.2 years
May 6, 2002
November 17, 2009
February 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Change in Composite Manual Muscle Testing (MMT) Score
The primary outcome measure was the rate of change in the MMT score. MMT involved the examination of 34 muscle groups with standard positioning. The final MMT score represented an average of the 34 muscles examined, and ranged from 10 to 0(10 normal strength, 0 paralyzed). The individual muscle score was based on the medical research council (MRC) grading scale (1-5) modified to a 10 point system corresponding to the MRC modifications of plus and minus (5, 5-,4+,4,4-,3+,3, 3-,2,1,0; with 5 being normal strength and 0 paralyzed).
Baseline and 24 months
Secondary Outcomes (2)
Number of Participants Alive and Tracheostomy-free at 24 Months
baseline to 24 months
Rate of Change in ALS Functional Rating Scale.
Baseline and 24 months
Study Arms (2)
IGF-1
ACTIVE COMPARATORInsulin like growth factor, type 1 will be given 0.05 mg per kg body weight subcutaneously twice daily
Placebo
PLACEBO COMPARATORPlacebo arm
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- ALS Associationcollaborator
- Cephaloncollaborator
Study Sites (20)
Mayo Clinic in Scottsdale
Scottsdale, Arizona, 85259, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Mayo Clinic in Jacksonville
Jacksonville, Florida, 32224, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55404, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
Beth Israel Medical Center
New York, New York, 10003, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania, Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Methodist Hospital
Houston, Texas, 77030, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Froedtert and Medical College Clinics
Milwaukee, Wisconsin, 53226, United States
University of Puerto Rico
San Juan, 00935, Puerto Rico
Related Publications (2)
Howe CL, Bergstrom RA, Horazdovsky BF. Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. Neurology. 2009 Oct 13;73(15):1247; author reply 1247-8. doi: 10.1212/WNL.0b013e3181b26ae6. No abstract available.
PMID: 19822878BACKGROUNDSorenson EJ, Windbank AJ, Mandrekar JN, Bamlet WR, Appel SH, Armon C, Barkhaus PE, Bosch P, Boylan K, David WS, Feldman E, Glass J, Gutmann L, Katz J, King W, Luciano CA, McCluskey LF, Nash S, Newman DS, Pascuzzi RM, Pioro E, Sams LJ, Scelsa S, Simpson EP, Subramony SH, Tiryaki E, Thornton CA. Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. Neurology. 2008 Nov 25;71(22):1770-5. doi: 10.1212/01.wnl.0000335970.78664.36.
PMID: 19029516RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eric J. Sorenson, MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Sorenson, M.D.
Department of Neurology, Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2002
First Posted
May 7, 2002
Study Start
June 1, 2003
Primary Completion
August 1, 2007
Study Completion
December 1, 2007
Last Updated
February 15, 2013
Results First Posted
February 15, 2013
Record last verified: 2013-02