Evidence map›Paper›PMID 19029516›Full record

Trial reportNeurology2008

Subcutaneous IGF-1 is not beneficial in 2-year ALS trial.

E J Sorenson, A J Windbank, J N Mandrekar, W R Bamlet, S H Appel, C Armon, P E Barkhaus, P Bosch, K Boylan, W S David and 17 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00035815 (Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis), which is not on this map. Cited by 105 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
105citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00035815 phase3completednot on this map

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

TypeinterventionalSponsorMayo ClinicRan2003 to 2007Enrolled330ConditionsAmyotrophic Lateral SclerosisArmsInsulin like growth factor, type 1, Placebo
3 · Its place in the literature

Who cites it

105 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Treatment for cramps in amyotrophic lateral sclerosis/motor neuron disease.The Cochrane database of systematic reviews · 2012
    Pooled it
  4. Treatment for familial amyotrophic lateral sclerosis/motor neuron disease.The Cochrane database of systematic reviews · 2009
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Type 2 diabetes mellitus, antidiabetics, and the risk of amyotrophic lateral sclerosis.Amyotrophic lateral sclerosis & frontotemporal degeneration · 2025
    Article
  13. Review
  14. GHRH and its analogues in central nervous system diseases.Reviews in endocrine & metabolic disorders · 2025
    Review
  15. Article
  16. Observational
  17. Review
  18. Review
  19. Review
  20. Therapeutic targeting of ALS pathways: Refocusing an incomplete picture.Annals of clinical and translational neurology · 2023
    Review

45 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

E J SorensonDepartment of Neurology, Mayo Clinic, 200 1st St. SW, Rochester, MN 55905, USA. sorenson.eric@mayo.edu
A J Windbank
J N Mandrekar
W R Bamlet
S H Appel
C Armon
P E Barkhaus
P Bosch
K Boylan
W S David
E Feldman
J Glass
L Gutmann
J Katz
W King
C A Luciano
L F McCluskey
S Nash
D S Newman
R M Pascuzzi
E Pioro
L J Sams
S Scelsa
E P Simpson
S H Subramony
E Tiryaki
C A Thornton

Funding

IGF-I/ALS TrialR01NS042759 · NINDS · MAYO CLINIC ROCHESTER · PI SORENSON, ERIC · 2002 to 2007
$7.7M
NINDS NIH HHS R01 NS042759NINDS NIH HHS R01 NS 42759
6 · The paper itself

Abstract

backgroundPrevious human clinical trials of insulin-like growth factor type I (IGF-1) in amyotrophic lateral sclerosis (ALS) have been inconsistent. This phase III, randomized, double-blind, placebo-controlled study was undertaken to address whether IGF-1 benefited patients with ALS.

methodsA total of 330 patients from 20 medical centers were randomized to receive 0.05 mg/kg body weight of human recombinant IGF-1 given subcutaneously twice daily or placebo for 2 years. The primary outcome measure was change in their manual muscle testing score. Secondary outcome measures included tracheostomy-free survival and rate of change in the revised ALS functional rating scale. Intention to treat analysis was used.

resultsThere was no difference between treatment groups in the primary or secondary outcome measures after the 2-year treatment period.

conclusionsInsulin-like growth factor type I does not provide benefit for patients with amyotrophic lateral sclerosis.

Indexed as

Amyotrophic Lateral SclerosisCentral Nervous System AgentsDeglutitionDouble-Blind MethodFemaleHand StrengthHumansInjections, SubcutaneousInsulin-Like Growth Factor IKaplan-Meier EstimateMaleMiddle AgedResearch DesignThromboembolismTime FactorsTracheostomyCentral Nervous System AgentsInsulin-Like Growth Factor I

Identifiers

PMID19029516
PMCPMC2617770

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.