ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00035815
Recruitment Status : Completed
First Posted : May 7, 2002
Results First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
ALS Association
Cephalon
Information provided by:
Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Amyotrophic Lateral Sclerosis
Interventions: Drug: Insulin like growth factor, type 1
Drug: Placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2002
First Posted: May 7, 2002
Results First Submitted: November 17, 2009
Results First Posted: February 15, 2013
Last Update Posted: February 15, 2013