Trial · NCT00035815

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

NCT00035815, Phase 3, Completed, Mayo Clinic; results first posted 2013-02-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial. Trials, record NCT00035815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00035815

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
NCT number: NCT00035815
Status: Completed
Phases: Phase 3
Enrollment: 330 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Amyotrophic Lateral Sclerosis
Interventions: Insulin like growth factor, type 1, Placebo
First posted: 2002-05-07
Last updated: 2013-02-15
Results first posted: 2013-02-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rate of Change in Composite Manual Muscle Testing (MMT) Score	Baseline and 24 months	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).
Secondary	Number of Participants Alive and Tracheostomy-free at 24 Months	baseline to 24 months	Patients who elected to proceed to tracheostomy were assessed the month of their procedure. Subjects who continuously utilized non-invasive positive pressure ventilation for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous Non Invasive Positive Pressure Ventilation (NIPPV). All subjects were followed for the 24 month time period.
Secondary	Rate of Change in ALS Functional Rating Scale.	Baseline and 24 months	The final secondary outcome measure was the rate of change in the ALS Functional Rating Scale (ALSFRS-r) score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). This is a scale from 0 to 48 assessing functional impairment in 12 clinically relevant areas in ALS. Forty-eight is normal with full function and zero is total loss of function in all clinical functions. As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Rate of Change in Composite Manual Muscle Testing (MMT) Score	Baseline and 24 months	MMT units per month	MEAN
SECONDARY	Number of Participants Alive and Tracheostomy-free at 24 Months	baseline to 24 months	participants	NUMBER
SECONDARY	Rate of Change in ALS Functional Rating Scale.	Baseline and 24 months	Units on a scale per month	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Rate of Change in Composite Manual Muscle Testing (MMT) Score	IGF-1	0.44	Standard Deviation 0.57	MMT units per month
Rate of Change in Composite Manual Muscle Testing (MMT) Score	Placebo	0.39	Standard Deviation 0.39	MMT units per month
Number of Participants Alive and Tracheostomy-free at 24 Months	IGF-1	93	0.77 to 1.4	participants
Number of Participants Alive and Tracheostomy-free at 24 Months	Placebo	90	1 to 1	participants
Rate of Change in ALS Functional Rating Scale.	IGF-1	2.5	Standard Deviation 3.2	Units on a scale per month
Rate of Change in ALS Functional Rating Scale.	Placebo	2.2	Standard Deviation 2.1	Units on a scale per month

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IGF-1	167
Overall Study	STARTED	Placebo	163
Overall Study	COMPLETED	IGF-1	150
Overall Study	COMPLETED	Placebo	152
Overall Study	NOT COMPLETED	IGF-1	17
Overall Study	NOT COMPLETED	Placebo	11

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Site reactions	Skin and subcutaneous tissue disorders	IGF-1	88	167	88
other	Site reactions	Skin and subcutaneous tissue disorders	Placebo	92	163	92
other	Headache	Nervous system disorders	IGF-1	22	167	22
other	Headache	Nervous system disorders	Placebo	22	163	22
other	Hepatotoxicity	Hepatobiliary disorders	IGF-1	14	167	14
other	Hepatotoxicity	Hepatobiliary disorders	Placebo	8	163	8
other	Change in visual acuity	Eye disorders	IGF-1	23	167	23
other	Change in visual acuity	Eye disorders	Placebo	20	163	20
other	Abnormal blood chemistries (other than liver)	Metabolism and nutrition disorders	IGF-1	10	167	10
other	Abnormal blood chemistries (other than liver)	Metabolism and nutrition disorders	Placebo	13	163	13

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IGF-1
Total, all-cause mortality	Placebo
Total, other adverse events	IGF-1	103	167
Total, other adverse events	Placebo	92	163
Total, serious adverse events	IGF-1	18	167
Total, serious adverse events	Placebo	12	163

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19029516	RESULT	PubMed
19822878	BACKGROUND	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01NS042759	IGF-I/ALS Trial	SORENSON, ERIC	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2002 to 2007

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
IGF-1 vs Placebo: Number of Participants Alive and Tracheostomy-free at 24 Months	Trial comparisons
IGF-1 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00035815

GET https://conductscience.org/api/trials/v1/NCT00035815/registered

API reference For AI assistants