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Motor Neuron Disease clinical trials

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NCT ID: NCT05866926 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

ADOREXT
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis

NCT ID: NCT05683860 Terminated - ALS Clinical Trials

Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)

Start date: December 14, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is an OLE study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of WVE-004 in adult patients with ALS, FTD, or mixed ALS/FTD phenotype with a documented mutation in the C9orf72 gene. To participate in the study, patients must have successfully completed Phase 1b/2a WVE-004-001 study.

NCT ID: NCT05442775 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

COURAGE OLE
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)

NCT ID: NCT05237284 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)

HIMALAYA
Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

This is a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy, safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in male and female participants, 18 to 80 years of age with ALS followed by an open-label, long-term extension period. Study ACT16970 consists of 2 parts (A and B) as follows: Part A is a 24-week, double blind, placebo-controlled part, preceded by a screening period of up to 4 weeks before Day 1. On Day 1 of Part A, participants will be randomized in a 2:1 ratio to the SAR443820 treatment arm or matching placebo arm as listed below: - Treatment arm: SAR443820, BID - Placebo arm: Placebo, BID Randomization will be stratified by the geographic region of the study site, region of ALS onset (bulbar vs other areas), use of riluzole (yes vs no), use of edaravone (yes vs no) and use of the combination of sodium phenylbutyrate and taurursodiol (named Relyvrio in the United States of America [USA] and Albrioza in Canada) (yes vs no). Participants will attend in-clinic study assessments at baseline (Day 1), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 16, Week 20, Week 21, Week 22, Week 23, and Week 24. All ongoing participants at Week 24 will rollover to open-label extension Part B. The Week 24 Visit is the end of Part A and the beginning of Part B. Part B is an open-label, long-term extension period that starts from Week 24 and continues up to Week 106. The objectives of Part B are to provide extended access to SAR443820 participants in Part A and to further evaluate the safety and efficacy of long-term SAR443820 treatment. The treatment assignment of participants at randomization in Part A will remain blinded to Investigators, participants, and site personnel until the end of Part B. Every participant, except those who discontinue Investigational Medicinal Product (IMP) treatment permanently in Part A, will receive BID oral tablets of SAR443820 in Part B.

NCT ID: NCT05053035 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS

Start date: September 2, 2021
Phase: Phase 2
Study type: Interventional

A phase 2 double-blind, placebo-controlled study of AL001 in participants with C9orf72-associated ALS.

NCT ID: NCT04944784 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

COURAGE-ALS
Start date: August 16, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

NCT ID: NCT04931862 Terminated - ALS Clinical Trials

Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)

FOCUS-C9
Start date: June 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of intrathecal (IT) WVE-004 in adult patients with C9orf72-associated ALS or FTD. To participate in the study, patients must have a documented mutation (GGGGCC [G4C2] repeat expansion) in the first intronic region of the C9orf72 gene and be diagnosed with ALS or FTD.

NCT ID: NCT04749433 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Study of [11C]CPPC to Assess the Safety and Tolerability in Patients With ALS

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

The goal of this study is to evaluate the safety of using the [5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide] ([11C]CPPC) radiotracer in positron emission tomography (PET) imaging of people with amyotrophic lateral sclerosis (ALS). The investigators are also interested to see whether use of this radiotracer reveals imaging differences between patients with ALS and healthy patients.

NCT ID: NCT04579666 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Start date: September 30, 2020
Phase: Phase 2
Study type: Interventional

This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

NCT ID: NCT04428775 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease

Start date: September 8, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, randomized, open-label, multi-center, multi-dose study for subjects with mild to moderate ALS. The protocol is designed to determine whether ALZT-OP1a treatment will positively impact neuro-inflammatory biomarkers and slow down or arrest functional decline in subjects with mild to moderate ALS.