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

This study has been completed.
Sponsor:
Collaborators:
ALS Association
Cephalon
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00035815
First received: May 6, 2002
Last updated: February 13, 2013
Last verified: February 2013
Results First Received: November 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Amyotrophic Lateral Sclerosis
Interventions: Drug: Insulin like growth factor, type 1
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from 20 medical centers from June 2003 to August 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized and initiated on treatment at the time of enrollment.

Reporting Groups
  Description
IGF-1 The insulin-like growth factor type 1 (IGF-1) arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
Placebo Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.

Participant Flow:   Overall Study
    IGF-1     Placebo  
STARTED     167 [1]   163 [1]
COMPLETED     150     152  
NOT COMPLETED     17     11  
Withdrawal by Subject                 17                 11  
[1] Enrollment began June 2003, accrual was for 2 years, follow-up period was 2 years.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IGF-1 The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
Placebo Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
Total Total of all reporting groups

Baseline Measures
    IGF-1     Placebo     Total  
Number of Participants  
[units: participants]
  167     163     330  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     135     129     264  
>=65 years     32     34     66  
Age  
[units: years]
Mean ± Standard Deviation
  53.9  ± 12.2     54.8  ± 11.2     54.4  ± 11.7  
Gender  
[units: participants]
     
Female     57     63     120  
Male     110     100     210  
Region of Enrollment  
[units: participants]
     
United States     167     163     330  



  Outcome Measures
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1.  Primary:   Rate of Change in Composite Manual Muscle Testing (MMT) Score   [ Time Frame: Baseline and 24 months ]

2.  Secondary:   Number of Participants Alive and Tracheostomy-free at 24 Months   [ Time Frame: baseline to 24 months ]

3.  Secondary:   Rate of Change in ALS Functional Rating Scale.   [ Time Frame: Baseline and 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eric J. Sorenson, MD
Organization: Mayo Clinic
phone: 507 538-1037
e-mail: sorenson.eric@mayo.edu


Publications of Results:
Other Publications:

Responsible Party: Eric Sorenson, M.D., Department of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00035815     History of Changes
Other Study ID Numbers: 1461-01, R01NS042759
Study First Received: May 6, 2002
Results First Received: November 17, 2009
Last Updated: February 13, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration