HEALEY ALS Platform Trial - Regimen A Zilucoplan

Status Completed

Clinical Trial Summary

Clinical Trial 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 A - Zilucoplan, the participant will complete a screening visit to assess additional Regimen A eligibility criteria. Once Regimen A eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active zilucoplan or matching placebo. Regimen A will enroll by invitation, as participants may not choose to enroll in Regimen A. 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 A. For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04436497
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	July 29, 2020
Completion date	May 4, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04428775` - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease	Phase 2
Recruiting	`NCT04998305` - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps	Phase 1/Phase 2
Recruiting	`NCT05951556` - Telehealth Implementation of Brain-Computer Interface	N/A
Terminated	`NCT04579666` - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)	Phase 2
Recruiting	`NCT04082832` - CuATSM Compared With Placebo for Treatment of ALS/MND	Phase 2/Phase 3
Completed	`NCT01925196` - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed	`NCT02496767` - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year	Phase 3
Recruiting	`NCT04816227` - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting	`NCT04494256` - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation	Phase 1/Phase 2
Completed	`NCT03706391` - Study of ALS Reversals 4: LifeTime Exposures
Recruiting	`NCT04882904` - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.	N/A
Completed	`NCT04557410` - Open Label Study: Treatment of ALS Fatigue With PolyMVA	Phase 1
Active, not recruiting	`NCT04948645` - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis	Phase 1
Not yet recruiting	`NCT04089696` - Validation of the "ExSpiron©" in Patients With ALS	N/A
Not yet recruiting	`NCT06450691` - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts	N/A
Not yet recruiting	`NCT04220190` - RAPA-501 Therapy for ALS	Phase 2/Phase 3
Not yet recruiting	`NCT05860244` - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients	Phase 2
Recruiting	`NCT02917681` - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis	Phase 1/Phase 2
Active, not recruiting	`NCT03067857` - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease	Phase 1/Phase 2
Recruiting	`NCT02874209` - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis	N/A