Clinical trials: Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)
The objective of this trial was to assess the efficacy, safety, and PK/PD effects of CNM-Au8 as a disease-modifying agent for the treatment of ALS by utilizing electrophysiological measures to detect preservation of motor neuron…
- Trial name
- RESCUE-ALS (NCT04098406)
- Testing
- CNM-Au8
- Where
- 2 sites in Australia
- Volunteers
- 45 people
- Sponsor
- Clene Nanomedicine
Amyotrophic Lateral Sclerosis, Renal Insufficiency
Dexpramipexole Renal PK Study
This is a multicenter, open-label, single-dose, PK and safety study in subjects with various stages of renal impairment.
- Trial name
- NCT01424176
- Testing
- Dexpramipexole (dose 1), Dexpramipexole (dose 2)
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Knopp Biosciences
Amyotrophic Lateral Sclerosis
Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis
ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects…
- Trial name
- NCT05981040
- Testing
- ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg
- Where
- 7 sites in India
- Volunteers
- 24 people
- Sponsor
- Zydus Lifesciences Limited
Amyotrophic Lateral Sclerosis
A Study of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
The primary objective of this study is to demonstrate a pharmacodynamic effect of CK 2017357 on measures of skeletal muscle function or fatigability in patients with ALS.
- Trial name
- NCT01089010
- Testing
- 250 mg CK-2017357, 500 mg CK-2017357
- Where
- 15 sites in United States
- Volunteers
- 67 people
- Sponsor
- Cytokinetics
Amyotrophic Lateral Sclerosis (ALS)
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are…
- Trial name
- NCT03280056
- Testing
- NurOwn® (MSC-NTF cells), Bone Marrow aspiration
- Where
- 6 sites in United States
- Volunteers
- 196 people
- Sponsor
- Brainstorm-Cell Therapeutics
Amyotrophic Lateral Sclerosis
Extension Study Evaluating The Safety And Tolerability of AMX0035
The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).
- Trial name
- NCT05619783
- Testing
- AMX0035
- Where
- 46 sites in Belgium, France and 9 more
- Volunteers
- 352 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Amyotrophic Lateral Sclerosis (ALS)
A Phase Ⅰ/Ⅱa Study of SNUG01 in Adult Subjects With ALS
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy of SNUG01 in in adult subjects with Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- NCT07169175
- Testing
- SNUG01
- Where
- 4 sites in United States, China
- Volunteers
- 21 people
- Sponsor
- SineuGene Therapeutics Co., Ltd.
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
Tetraplegia/Tetraparesis, Quadriplegia
UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
The UAE-PRIME Study is a feasibility study designed to assess the initial clinical safety and functionality of the Neuralink N1 Implant and R1 Robot.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury
- Trial name
- UAE-PRIME (NCT06992596)
- Testing
- N1 Implant, R1 Robot
- Where
- United Arab Emirates
- Volunteers
- 10 people
- Sponsor
- Neuralink Corp
Amyotrophic Lateral Sclerosis
Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS
ALSUMMIT is a double-blind, randomized, placebo-controlled, multi-center, parallel, phase III clinical trial to evaluate and confirm the efficacy and long-term safety of repeated Lenzumestrocel (Neuronata-R® inj.) treatment.
- Trial name
- ALSummit (NCT04745299)
- Testing
- Lenzumestrocel, Riluzole
- Where
- 5 sites in South Korea
- Volunteers
- 123 people
- Sponsor
- Corestemchemon, Inc.
Amyotrophic Lateral Sclerosis
An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)
The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of tofersen in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation.
- Trial name
- VALOR (Part C) (NCT02623699)
- Testing
- Tofersen
- Where
- 40 sites in United States, Australia and 10 more
- Volunteers
- 176 people
- Sponsor
- Biogen
Amyotrophic Lateral Sclerosis
FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS
The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomized, double-blind, placebo-controlled Phase 1/2 trial to evaluate the safety and tolerability of TRCN-1023 in adults living with ALS.
- Trial name
- FUNCtion ALS (NCT07674667)
- Testing
- TRCN-1023
- Where
- 6 sites in Germany, Netherlands and 1 more
- Volunteers
- 30 people
- Sponsor
- Trace Neuroscience, Inc.
Amyotrophic Lateral Sclerosis (ALS)
Safety Study of XT-150 in Participants With ALS
This is a Phase 1, open-label, multi-center safety study of XT-150 in adult participants with Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- NCT06704347
- Testing
- XT-150
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Xalud Therapeutics, Inc.
Amyotrophic Lateral Sclerosis
ALS Phase II Study of NX210c
This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS).
- Trial name
- SEALS (NCT06365216)
- Testing
- NX210c
- Where
- 16 sites in France
- Volunteers
- 80 people
- Sponsor
- Axoltis Pharma
Amyotrophic Lateral Sclerosis, Fasciculation
Study to Evaluate the Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With ALS
The FLX-787-106 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- NCT03338114
- Testing
- FLX-787-ODT (orally disintigrating tablet)
- Where
- United States
- Sponsor
- Flex Pharma, Inc.
Amyotrophic Lateral Sclerosis, Motor Neuron Disease
IC14 for Treatment of Amyotrophic Lateral Sclerosis
Fifty patients with amyotrophic lateral sclerosis that is progressing rapidly will be randomized to receive either the monoclonal antibody IC14 or placebo to be given intravenously over two hours twice weekly for 12 weeks.
- Trial name
- NCT03508453
- Testing
- IC14
- Where
- Australia
- Sponsor
- Implicit Bioscience
Amyotrophic Lateral Sclerosis
A Study to Evaluate, Safety, Tolerability, and PK of AP-101 in Participants With ALS
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
- Trial name
- NCT05039099
- Testing
- AP-101
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 73 people
- Sponsor
- AL-S Pharma
Amyotrophic Lateral Sclerosis
An Intermediate Size Expanded Access Protocol of AMX0035 for ALS
The Expanded Access Program will provide access and assess the safety of AMX0035 for the treatment of people living with ALS.
- Trial name
- NCT05286372
- Testing
- AMX0035
- Where
- 21 sites in United States, Puerto Rico
- Sponsor
- Amylyx Pharmaceuticals Inc.
Amyotrophic Lateral Sclerosis
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
The purpose of this study is to evaluate the long-term safety of intramuscular administration of Engensis in Participants with Amyotrophic Lateral Sclerosis who were previously randomized, received treatment, and completed the…
- Trial name
- REViVALS-1B (NCT05176093)
- Testing
- Engensis
- Where
- 2 sites in United States, South Korea
- Volunteers
- 8 people
- Sponsor
- Helixmith Co., Ltd.
Amyotrophic Lateral Sclerosis
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)
In this study, researchers will learn more about the safety of tofersen, also known as Qalsody®. This is a drug available for doctors to prescribe for participant with a certain type of amyotrophic lateral sclerosis, also known…
- Trial name
- NCT07259980
- Testing
- Tofersen
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Biogen