Amyotropic Lateral Sclerosis (ALS) clinical trials at UC Irvine
11 in progress, 2 open to eligible people
Intrathecally Administered Gene Therapy AMT-162 in Adult Participants with SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS)
open to eligible people ages 18 years and up
This is the study of AMT-162 in Participants with SOD1-ALS and is designed to evaluate the safety, tolerability, and exploratory efficacy of intrathecally administered gene therapy AMT-162. AMT-162-001 is a Phase 1/2, multi-center, single ascending dose study.
Irvine, California and other locations
Clinical Procedures to Support Research in ALS
open to eligible people ages 18 years and up
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders.
Irvine, California and other locations
Pridopidine in Amyotrophic Lateral Sclerosis (EAP 2)
Sorry, not accepting new patients
This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials. Pridopidine will be given at a dose of 45 mg twice daily p.o. (or via feeding tube). Each patient will be followed for 2 years with regularly scheduled visits. The screening and baseline visits will be performed in person; subsequent visits may occur in person or remotely. Recommended in-person visits will occur at Weeks 12, 52, 78, and end of treatment (Week 104 or early termination). If the patient is unable to complete the visits in person, these visits may also be completed remotely.
Orange, California and other locations
RAPA-501 Therapy for ALS Expanded Access Protocol
Sorry, not accepting new patients
RAPA-501-ALS is an Intermediate-Size Expanded Access Trial of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).
Irvine, California and other locations
Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS
Sorry, not accepting new patients
The primary objective of the intermediate expanded access protocol is to provide access to the investigational product, CNM-Au8, to up to 300 people living with ALS (pALS). No formal clinical hypotheses are being evaluated with concurrent controls. Secondary objectives include assessment of the safety of CNM-Au8 treatment in pALS. Safety will be assessed through the frequency of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) assessed as 'severe', discontinuations due to TEAEs, and laboratory abnormalities assessed as clinically significant during routine clinical monitoring (as applicable).
Orange, California and other locations
Fosigotifator in Patients With Amyotrophic Lateral Sclerosis
Sorry, in progress, not accepting new patients
Fosigotifator is an investigational drug being researched for the treatment of Amyotrophic Lateral Sclerosis. This is an up to 156-week, 2-part study. Part 1 will be a 4-week, randomized, double-blind, placebo-controlled study; Part 2 will be up to a 152-week active treatment extension (ATE) during which all subjects will receive Fosigotifator.
Irvine, California and other locations
TPN-101 in Patients With C9ORF72 ALS/FTD
Sorry, in progress, not accepting new patients
This is a Phase 2a study to assess the the safety and tolerability of TPN-101 in patients with Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated with Hexanucleotide Repeat Expansion in the C9orf72 gene (C9ORF72 ALS/FTD).
Orange, California and other locations
HEALEY ALS Platform Trial - Master Protocol
Sorry, in progress, not accepting new patients
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.
Orange, California and other locations
AMX0035 for Amyotrophic Lateral Sclerosis Treatment
Sorry, in progress, not accepting new patients
The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS
Orange, California and other locations
PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALS
Sorry, in progress, not accepting new patients
This study will assess the efficacy and safety of PTC857 treatment in participants diagnosed with ALS.
Orange, California and other locations
Intermuscular Coherence as a Biomarker for ALS
Sorry, not currently recruiting here
The specific aims of this study are to: 1. Determine if a painless and quick measurement of muscle activity using surface electrodes can help with the diagnosis of ALS. Specifically, we ask if a measure of intermuscular coherence (IMC-βγ), when added to current diagnostic criteria (Awaji criteria), can differentiate ALS from mimic diseases more accurately and earlier than currently possible. 2. Characterize IMC-βγ in neurotypical subjects by age, sex, race, and ethnicity. 3. Follow a cohort of ALS patients longitudinally to determine if IMC-βγ changes with ALS disease progression and whether such changes correlate with functional and clinical scores, or survival.
Irvine, California and other locations
Our lead scientists for Amyotropic Lateral Sclerosis (ALS) research studies include Namita Goyal, MD.
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