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Study · Randomized controlled trial · n = 266 · 1997

5 results

Effect of recombinant human insulin-like growth factor-I on progression of ALS. A placebo-controlled study. The North America ALS/IGF-I Study Group.

Lai EC, Felice KJ, Festoff BW, Gawel MJ, Gelinas DF, Kratz R, Murphy MF, Natter HM, Norris FH, Rudnicki SA

Neurology1 Dec 1997Cited by 245 (Europe PMC)

PMID9409357 (opens in a new tab)DOI10.1212/wnl.49.6.1621 (opens in a new tab)PepBankPUB-09409357
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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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In ALS patients, high-dose rhIGF-I slowed functional impairment progression by 26% versus placebo.

    In plain wordsIn ALS patients, high-dose rhIGF-I slowed worsening of function by 26% compared with placebo.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    DecreaseFunctional impairment progression
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    0.10 mg/kg/day · 9 monthsAs given in this study (human).

    Measurements

    Slower progression of functional impairment versus placebo
    26%
    high-dose rhIGF-I 0.10 mg/kg/day versus placebo
    P value for functional impairment progression versus placebo
    0.01 unitless
    high-dose rhIGF-I 0.10 mg/kg/day versus placebo

    Source sentences

    Summary
    Progression of functional impairment in patients receiving high-dose (0.10 mg/kg/day) rhIGF-I was 26% slower than in patients receiving placebo (p = 0.01).
    2 context sentences
    Summary · context
    A double-blind, placebo-controlled, randomized study of 266 patients was conducted at eight centers in North America.
    Summary · context
    Placebo or rhIGF-I (0.05 mg/kg/day or 0.10 mg/kg/day) was administered for 9 months.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In ALS patients, high-dose rhIGF-I slowed quality-of-life decline versus placebo.

    In plain wordsIn ALS patients, high-dose rhIGF-I slowed quality-of-life decline compared with placebo.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    DecreaseQuality-of-life decline
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    0.10 mg/kg/day · 9 monthsAs given in this study (human).

    Source sentences

    Summary
    The high-dose treatment group was less likely to terminate the study due to protocol-defined markers of disease symptom progression, and members in this group exhibited a slower decline in quality of life, as assessed by the SIP.
    2 context sentences
    Summary · context
    A double-blind, placebo-controlled, randomized study of 266 patients was conducted at eight centers in North America.
    Summary · context
    Placebo or rhIGF-I (0.05 mg/kg/day or 0.10 mg/kg/day) was administered for 9 months.
  3. 03HumanRandomized controlled trialSafety outcome

    In ALS patients, clinically significant adverse experiences were comparable with low-dose rhIGF-I, high-dose rhIGF-I, and placebo.

    In plain wordsIn ALS patients, significant side effects were similar with low-dose rhIGF-I, high-dose rhIGF-I, and placebo.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeClinically significant adverse experiences
    Study

    n = 266

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.05 mg/kg/day and 0.10 mg/kg/day · 9 monthsAs given in this study (human).

    Source sentences

    Summary
    The incidence of clinically significant adverse experiences was comparable among the three treatment groups.
    2 context sentences
    Summary · context
    A double-blind, placebo-controlled, randomized study of 266 patients was conducted at eight centers in North America.
    Summary · context
    Placebo or rhIGF-I (0.05 mg/kg/day or 0.10 mg/kg/day) was administered for 9 months.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In ALS patients, high-dose rhIGF-I reduced the likelihood of study termination for disease progression versus placebo.

    In plain wordsIn ALS patients, high-dose rhIGF-I reduced study termination for worsening disease compared with placebo.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    DecreaseTermination for disease progression
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    0.10 mg/kg/day · 9 monthsAs given in this study (human).

    Source sentences

    Summary
    The high-dose treatment group was less likely to terminate the study due to protocol-defined markers of disease symptom progression, and members in this group exhibited a slower decline in quality of life, as assessed by the SIP.
    2 context sentences
    Summary · context
    A double-blind, placebo-controlled, randomized study of 266 patients was conducted at eight centers in North America.
    Summary · context
    Placebo or rhIGF-I (0.05 mg/kg/day or 0.10 mg/kg/day) was administered for 9 months.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In ALS patients, low-dose rhIGF-I showed trends similar to high-dose treatment, suggesting a dose-dependent response.

    In plain wordsIn ALS patients, low-dose rhIGF-I showed trends similar to high-dose treatment.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    Direction not reportedLow-dose treatment trends
    Study

    n: not reported in source

    Comparator
    High-dose rhIGF-I
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    0.05 mg/kg/day · 9 monthsAs given in this study (human).

    Source sentences

    Summary
    Patients receiving 0.05 mg/kg/day of rhIGF-I exhibited trends similar to those associated with high-dose treatment, suggesting a dose-dependent response.
    2 context sentences
    Summary · context
    A double-blind, placebo-controlled, randomized study of 266 patients was conducted at eight centers in North America.
    Summary · context
    Placebo or rhIGF-I (0.05 mg/kg/day or 0.10 mg/kg/day) was administered for 9 months.

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

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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