Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035815
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2002-05-06
Brief Title:
Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis ALS Trial
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis ALS
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS042759 | NIH | None | httpsreporternihgovquickSearchR01NS042759 |