Clinical trials: ALS
ALS
Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS
The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period.
- Trial name
- NCT05568615
- Testing
- MT-1186
- Where
- 11 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Shionogi
ALS
Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to…
- Trial name
- NCT04569084
- Testing
- MT-1186
- Where
- 95 sites in United States, Canada and 5 more
- Volunteers
- 384 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral…
- Trial name
- NCT04577404
- Testing
- MT-1186
- Where
- 44 sites in United States, Canada and 4 more
- Volunteers
- 124 people
- Sponsor
- Shionogi
ALS
A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
- Trial name
- AURORA (NCT06453668)
- Testing
- TCD601
- Where
- 3 sites in Sweden
- Volunteers
- 7 people
- Sponsor
- ITB-Med LLC
Japanese Patients With ALS
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy
- Trial name
- NCT04254913
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Shionogi
Japanese Patients With ALS
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
- Trial name
- NCT04176224
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early-stage ALS (within 2 years of ALS symptoms onset).
- Trial name
- ASTRALS (NCT06643481)
- Testing
- VHB937
- Where
- 74 sites in United States, Australia and 15 more
- Volunteers
- 251 people
- Sponsor
- Novartis Pharmaceuticals
Amyotrophic Lateral Sclerosis, ALS
Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS.
- Trial name
- NCT04259255
- Testing
- Edaravone (Radicava®/Radicava ORS®)
- Where
- 20 sites in United States, Canada
- Volunteers
- 74 people
- Sponsor
- Shionogi
Neurologic Disorders, Nervous System Diseases
Neurologic Stem Cell Treatment Study
This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will…
- Conditions
- Neurologic Disorders, Nervous System Diseases, Neurodegenerative Diseases, Neurological Disorders
- Trial name
- NEST (NCT02795052)
- Testing
- Intravenous and Intranasal BMSC
- Where
- 3 sites in United States, United Arab Emirates
- Volunteers
- 500 people
- Sponsor
- MD Stem Cells
Neurologic Disorder, ALS
Functional Outcomes and Control Using Synchron BCI - Canada
Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)
- Conditions
- Neurologic Disorder, ALS, Motor Neuron Disease
- Trial name
- FOCUS-CAN (NCT07446114)
- Testing
- Stentrode
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Synchron, Inc.
ALS
AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis
This study is a placebo-controlled Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide (ASO) AMX0114 in adult participants with amyotrophic lateral sclerosis…
- Trial name
- LUMINA (NCT06665165)
- Testing
- AMX0114
- Where
- 14 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
ALS, Amyotrophic Lateral Sclerosis
Intermediate Expanded Access Protocol CNMAu8.EAP04
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
- Conditions
- ALS, Amyotrophic Lateral Sclerosis, PALS
- Trial name
- NCT06408727
- Testing
- CNM-Au8
- Where
- 8 sites in United States
- Sponsor
- Clene Nanomedicine
Amyotrophic Lateral Sclerosis, ALS
A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients
FIH, Phase 1/2, multi-centre, randomised, double-blind, placebo controlled study with an optional open-label dosing extension to assess the safety, tolerability, efficacy, and Pharmacodynamics (PD) of single or multiple (up to 48…
- Trial name
- NCT06513546
- Volunteers
- 153 people
- Sponsor
- PLL TX AUSTRALIA PTY LTD
ALS (Amyotrophic Lateral Sclerosis)
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
The purpose of this study is to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic amyotrophic lateral sclerosis (ALS).
- Trial name
- NCT07100119
- Testing
- LY4256984
- Where
- 12 sites in Belgium, Canada and 3 more
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
ALS (Amyotrophic Lateral Sclerosis)
Safety and Tolerability Study of CTx1000 In Participants With Amyotrophic Lateral Sclerosis
This clinical study is in participants with Amyotrophic Lateral Sclerosis and is designed to evaluate the safety and tolerability of the gene therapy CTx1000.
- Trial name
- KOANEWA (NCT07401121)
- Testing
- AAV9 Gene therapy
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Celosia Therapeutics Pty Ltd
ALS (Amyotrophic Lateral Sclerosis), ALS
Kamlanoflast In Amyotrophic Lateral Sclerosis
This is a study of Kamlanoflast in patients with ALS. Kamlanoflast is orally administered over 24 weeks. Its effects on inflammatory and functional parameters will be studied.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis), ALS, Neuro-Degenerative Disease, Neuro-Degenerative Diseases
- Trial name
- NCT07396818
- Testing
- Kamlanoflast
- Volunteers
- 40 people
- Sponsor
- Inflammasome Therapeutics
ALS (Amyotrophic Lateral Sclerosis)
This Study Evaluates the Safety, Target Engagement, and Preliminary Efficacy of Galunisertib (TGF-βR1/ALK5 Inhibitor)Combined With Nerandomilast (PDE4 Inhibitor) in GREM2-positive ALS, a Biomarker-defined Subgroup Hypothesized to Reflect Heightened TGF-β/SMAD-driven Astrocytic and Fibrotic Signaling
Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive neurodegenerative disorder characterized by loss of upper and lower motor neurons, leading to muscle weakness, respiratory decline, and eventual mortality.
- Trial name
- NCT07321860
- Testing
- Galunisertib + Nerandomilast Combination
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Gipfel Life Sciences GmbH
Amyotrophic Lateral Sclerosis (ALS)
Extension Study of Participants From SPG302-ALS-001
This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS)
- Trial name
- NCT06903286
- Testing
- SPG302
- Where
- 3 sites in Australia
- Volunteers
- 16 people
- Sponsor
- Spinogenix
Amyotrophic Lateral Sclerosis (ALS)
The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis
A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects with Amyotrophic Lateral Sclerosis
- Trial name
- NCT07118319
- Testing
- Human Allogeneic Induced Pluripotent Stem Cells (iPSCs) -Derived Motor Neuron Progenitor Cells (XS228CN)
- Where
- China
- Volunteers
- 12 people
- Sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Amyotrophic Lateral Sclerosis Als
Evaluate the Safety and Efficacy of Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis
The goal of the study aims to evaluate the safety and tolerability of a single intrathecal injection of RJK002 in subjects with amyotrophic lateral sclerosis (ALS), and to determine the recommended Phase II dose (RP2D).
- Trial name
- NCT06493279
- Testing
- RJK002 Intrathecal injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- RJK Biopharma Ltd