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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00035815 (opens ClinicalTrials.gov in a new tab)Other id1461-01Other idR01NS042759
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
330 participants (actual)
Sponsor
Mayo Clinic · Other
Design
Randomized · Quadruple masking
Countries
2 countries

United States, Puerto Rico

Start
Jun 2003
Primary completion
Aug 2007
Completion
Dec 2007
First posted
7 May 2002 (estimated)
Last update posted
15 Feb 2013 (estimated)
Conditions
Amyotrophic Lateral Sclerosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200320042005200620072008
  1. Ph 3

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

    NCT00035815

    Jun 2003 to Dec 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place at approximately 6-month intervals.

Interventions

  • Insulin like growth factor, type 1Drug
  • PlaceboDrug

Arms2

  • Active comparator

    IGF-1

    Insulin like growth factor, type 1 will be given 0.05 mg per kg body weight subcutaneously twice daily

  • Placebo comparator

    Placebo

    Placebo arm

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Rate of Change in Composite Manual Muscle Testing (MMT) Score

    Time frame · Baseline and 24 months

    Registry description

    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 outcomes(2)

  1. Number of Participants Alive and Tracheostomy-free at 24 Months

    Time frame · baseline to 24 months

    Registry description

    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.

  2. Rate of Change in ALS Functional Rating Scale.

    Time frame · Baseline and 24 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 24 months

Rate of Change in Composite Manual Muscle Testing (MMT) Score

GroupValue (MMT units per month)Spread
IGF-10.440.57
Placebo0.390.39
Secondary and other outcome results(2)
Secondary outcomeNumber· baseline to 24 months

Number of Participants Alive and Tracheostomy-free at 24 Months

GroupValue (participants)
IGF-193
Placebo90
Secondary outcomeMean· Baseline and 24 months

Rate of Change in ALS Functional Rating Scale.

GroupValue (Units on a scale per month)Spread
IGF-12.53.2
Placebo2.22.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IGF-1The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.–18 / 167103 / 167
PlaceboPlacebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.–12 / 16392 / 163

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

3 results

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

Sorenson et al. 2008Neurologycited by 188

PMID 19029516PMC2617770DOI 10.1212/01.wnl.0000335970.78664.36PUB-19029516

Rights unknown3 results
Source linkSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria Patients entering this study: * Are between the ages of 18-80 years old. * Legal residents of the United States or Canada. * Have a history of a chronic onset of a progressive motor weakness of less than 24 months duration. * Fulfill El Escorial criteria of probable or definite ALS. * If female, are surgically sterile, two years postmenopausal, or if of child-bearing potential, must be using a medically acceptable method of birth control and agree to continue use of this method for the duration of the study. Acceptable methods include a barrier method with spermicide, oral contraceptives (normal doses are acceptable; low dose oral contraceptives or contraceptive implants must be used with a barrier method), intrauterine device (IUD), or abstinence. Have a negative pregnancy test. * Are able to comply with protocol requirements. * Can provide written informed consent. * Have a manual muscle testing score of less than 8. * Have a forced vital capacity by pulmonary function testing \*60% predicted. Exclusion Criteria: Patients entering this study will not: * Have any of the following conditions:renal disease (Creatine \> 2.0) or other active systemic disease * Have any clinically significant abnormalities on the prestudy laboratory evaluation, physical examination, ECG, chest x-ray or ophthalmologic exam. * Have any clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient. * Have Type I or Type II diabetes. * Have a history of cancer including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline) and carcinoma in-situ of the cervix (women only). * Have used an investigational drug within 30 days of baseline visit. * Have had a tracheostomy. * Have a Beck's Depression Inventory score \* 12. * Have legal residency outside of the United States or Canada. * Be pregnant or breast-feeding.

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