Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS)
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.
The objective of this trial was to determine whether IGF-1 (MyotrophinTM) slows progression
of weakness in amyotrophic lateral sclerosis (ALS). Three hundred thirty patients with ALS
from 20 medical centers participated in this double blind, placebo-controlled two-year
study. Half the patients received IGF-1 and the other half received placebo. The drug will
be administered twice a day.
ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of
motor neurons. IGF-1 is a neurotrophic factor essential for normal development of the
nervous system and shows protection of motor neurons in animal models and cell culture
systems. It is thought to block cell death pathways and promote muscle re-innervation and
axonal growth and regeneration.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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