HEALEY ALS Platform Trial - Master Protocol

Status Active, not recruiting

Clinical Trial 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.

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. In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen. The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting. Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized in a 3:1 ratio to either study drug or placebo. The following regimens are active in the trial: Regimen A - Zilucoplan Regimen B - Verdiperstat Regimen C - CNM-Au8 Regimen D - Priodopidine Regimen E - SLS-005 Trehalose Regimen F - ABBV-CLS-7262 Regimen G - DNL343 New regimens will be continuously added as new investigational products become available. The HEALEY ALS Platform Trial will enroll additional participants as each new regimen is available. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04297683
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	July 14, 2020
Completion date	April 2026

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	`NCT05860244` - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients	Phase 2
Not yet recruiting	`NCT04220190` - RAPA-501 Therapy for ALS	Phase 2/Phase 3
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