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Amyotropic Lateral Sclerosis (ALS) clinical trials at UC Irvine

10 in progress, 5 open to eligible people

Showing trials for
  • An Efficacy and Safety Study of Ravulizumab in ALS Participants

    open to eligible people ages 18 years and up

    The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

    Orange, California and other locations

  • Deep Phenotyping in Patients With ALS

    open to eligible people ages 18-75

    This study aims to establish a biorepository and phenotyping database to investigate longitudinal changes in ALS subjects. Blood, including DNA and RNA, cerebrospinal fluid (CSF) and electrophysiologic measures will be collected every 6 months over 1 and a half years. The database and specimen repository will be made available to ALS researchers on a merit basis.

    Orange, California and other locations

  • Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS

    open to eligible people ages 18-80

    A Phase 2b/3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.

    Orange, California and other locations

  • Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

    open to eligible people ages 18 years and up

    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. Epigenetic and protein biomarkers will also be investigated.

    Orange, California and other locations

  • Therapy in Amyotrophic Lateral Sclerosis (TAME)

    open to eligible people ages 18-85

    The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction with riluzole, can slow down the disease progression of patients with ALS including potentially improving their neuropsychiatric changes, as well as determine if serum biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS. Funding Source: FDA-OPD

    Irvine, California and other locations

  • Arimoclomol in Amyotropic Lateral Sclerosis

    Sorry, in progress, not accepting new patients

    A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

    Orange, California and other locations

  • Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

    Sorry, accepting new patients by invitation only

    A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS)who have completed the ORARIALS-01 trial.

    Orange, California and other locations

  • Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

    Sorry, in progress, not accepting new patients

    This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

    Orange, California and other locations

  • HEALEY ALS Platform Trial - Master Protocol

    Sorry, not currently recruiting here

    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

  • Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients

    Sorry, in progress, not accepting new 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 enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete Neurotrophic factors (NTFs). The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells

    Irvine, California and other locations

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