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Study · Randomized controlled trial · n = 330 · 2008

3 results

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

Sorenson EJ, Windbank AJ, Mandrekar JN, Bamlet WR, Appel SH, Armon C, Barkhaus PE, Bosch P, Boylan K, David WS, Feldman E, Glass J and 15 more

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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

Neurology1 Nov 2008Cited by 188 (Europe PMC)

PMID19029516 (opens in a new tab)PMCIDPMC2617770 (opens in a new tab)DOI10.1212/01.wnl.0000335970.78664.36 (opens in a new tab)PepBankPUB-19029516
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with ALS, IGF‑1 did not differ from placebo in manual muscle testing score change.

    In plain wordsIn patients with ALS, IGF‑1 did not change muscle testing scores more than placebo.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeManual muscle testing score
    Study

    n = 330

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    0.05 mg/kg twice daily · subcutaneous · 2 yearsAs given in this study (human).

    Source sentences

    Summary
    There was no difference between treatment groups in the primary or secondary outcome measures after the 2-year treatment period.
    2 context sentences
    Summary · context
    The primary outcome measure was change in their manual muscle testing score.
    Summary · context
    A 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.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with ALS, tracheostomy-free survival did not differ between IGF‑1 and placebo.

    In plain wordsIn patients with ALS, survival without tracheostomy did not differ between IGF‑1 and placebo.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeTracheostomy-free survival
    Study

    n = 330

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Mortality · Nervous system and cognition
    Studied dose
    0.05 mg/kg twice daily · subcutaneous · 2 yearsAs given in this study (human).

    Source sentences

    Summary
    There was no difference between treatment groups in the primary or secondary outcome measures after the 2-year treatment period.
    2 context sentences
    Summary · context
    Secondary outcome measures included tracheostomy-free survival and rate of change in the revised ALS functional rating scale.
    Summary · context
    A 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.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with ALS, revised ALS functional rating scale change did not differ between IGF‑1 and placebo.

    In plain wordsIn patients with ALS, functional score changes did not differ between IGF‑1 and placebo.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeRevised ALS functional rating scale change
    Study

    n = 330

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    0.05 mg/kg twice daily · subcutaneous · 2 yearsAs given in this study (human).

    Source sentences

    Summary
    There was no difference between treatment groups in the primary or secondary outcome measures after the 2-year treatment period.
    2 context sentences
    Summary · context
    Secondary outcome measures included tracheostomy-free survival and rate of change in the revised ALS functional rating scale.
    Summary · context
    A 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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00035815

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

Mayo Clinicn = 330Jun 2003 to Dec 2007

Amyotrophic Lateral Sclerosis

Trial pageClinicalTrials.govUpdated 15 Feb 2013

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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