Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615923
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2020-10-29
Brief Title:
HEALEY ALS Platform Trial - Regimen D Pridopidine
Sponsor:
Merit E Cudkowicz MD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
HEALEY ALS Platform Trial - Regimen D Pridopidine
Status:
COMPLETED
Status Verified Date:
2023-08
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 HEALEY ALS Platform Trial is a perpetual multi-center multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS
Regimen D will evaluate the safety and efficacy of a single study drug pridopidine in participants with ALS
Regimen D will evaluate the safety and efficacy of a single study drug pridopidine in participants with ALS
Detailed Description:
The HEALEY ALS Platform Trial is a perpetual multi-center multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS This trial is designed as a perpetual platform trial This means that there is a single Master Protocol dictating the conduct of the trial The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683
Once a participant enrolls into the Master Protocol and meets all eligibility criteria the participant will be eligible to be randomized into any currently enrolling regimen All participants will have an equal chance of being randomized to any currently enrolling regimen
If a participant is randomized to Regimen D Pridopidine the participant will complete a screening visit to assess additional Regimen D eligibility criteria Once Regimen D eligibility criteria are confirmed participants will complete a baseline assessment and be randomized in a 31 ratio to either active pridopidine or matching placebo
Regimen D will enroll by invitation as participants may not choose to enroll in Regimen D Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen D
For a list of enrolling sites please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683
Once a participant enrolls into the Master Protocol and meets all eligibility criteria the participant will be eligible to be randomized into any currently enrolling regimen All participants will have an equal chance of being randomized to any currently enrolling regimen
If a participant is randomized to Regimen D Pridopidine the participant will complete a screening visit to assess additional Regimen D eligibility criteria Once Regimen D eligibility criteria are confirmed participants will complete a baseline assessment and be randomized in a 31 ratio to either active pridopidine or matching placebo
Regimen D will enroll by invitation as participants may not choose to enroll in Regimen D Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen D
For a list of enrolling sites please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683
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