Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03068754
Status:
TERMINATED
Last Update Posted:
2020-10-14
First Post:
2017-02-23
Brief Title:
Study of Acthar Gel Acthar for Amyotrophic Lateral Sclerosis ALS
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Multicenter Double Blind Placebo Controlled Study to Assess the Efficacy and Safety of HP Acthar Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
As recommended by the studys independent Data and Safety Monitoring Board DSMB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
About 213 people with ALS will participate in this study There will be locations in North and South America
During the first part participants will be randomly assigned to a group like by flipping a coin Out of every 3
2 will get the study drug
1 will get a look-alike with no drug in it placebo
During the second part everyone will get the study drug
Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo
During the first part participants will be randomly assigned to a group like by flipping a coin Out of every 3
2 will get the study drug
1 will get a look-alike with no drug in it placebo
During the second part everyone will get the study drug
Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo
Detailed Description:
This is a multicenter multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS Approximately 213 participants will be enrolled
Following a screening period of up to 28 days participants with ALS and symptom onset defined as first muscle weakness or dysarthria 2 years prior to the Screening Visit will be randomized on a 21 basis to receive subcutaneous SC Acthar 02 mL 16 Units U daily QD or SC matching placebo 02 mL QD for 36 weeks followed by a 3-week taper
Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 02 mL 16 U daily
Following a screening period of up to 28 days participants with ALS and symptom onset defined as first muscle weakness or dysarthria 2 years prior to the Screening Visit will be randomized on a 21 basis to receive subcutaneous SC Acthar 02 mL 16 Units U daily QD or SC matching placebo 02 mL QD for 36 weeks followed by a 3-week taper
Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 02 mL 16 U daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None