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

This study has been completed.

Sponsor:

Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS)

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

History of Changes

Results First Received: November 17, 2009

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

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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.
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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

Sorenson 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.

Other Publications:

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.

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 )
Study First Received:	May 6, 2002
Results First Received:	November 17, 2009
Last Updated:	February 13, 2013

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