Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis ALS progressive weakness insulin-like growth factor-1 IGF-I Myotrophin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 330
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Insulin like growth factor, type 1 will be given 0.05 mg per kg body weight subcutaneously twice daily arm 2: Placebo arm

Interventions: intervention 1: Insulin like growth factor, type 1 intervention 2: Placebo
Intervention descriptions: intervention 1: 0.05 mg per kg body weight given subcutaneously twice daily intervention 2: The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.

Protocol document: