Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate riluzole across diverse therapeutic areas, including neurodegenerative diseases such as amyotrophic lateral sclerosis and motor neuron disease, psychiatric disorders like major depressive disorder, treatment-resistant schizophrenia, and posttraumatic stress disorder, as well as spinal cord injury and paroxysmal atrial fibrillation. Exhibiting recruitment statuses ranging from active recruiting and completed to active not recruiting and terminated, these protocols are sponsored by government entities such as the National Institute of Mental Health, academic medical centers, health service trusts, and private biopharmaceutical companies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07174492 NOT_YET_RECRUITING
Amyotrophic Lateral Sclerosis (ALS)
AB Science
 2026-01-01 PHASE3
NCT07447050 RECRUITING
Breast Cancer; Sarcoma; Gastric (Stomach) Cancer; Lung Cancer; Head and Neck Cancer; Colorectal Cancer; Ovarian Cancer; Liver Cancer; Genitourinary Cancer; Gynecologic Cancer
University of California, Irvine
 2025-12-23 PHASE2
NCT03127267 RECRUITING
Amyotrophic Lateral Sclerosis
AB Science
 2021-02-02 PHASE3
NCT06580002 RECRUITING
Breast Cancer; Sarcoma; Gastric Cancer; Lung Cancer; Head and Neck Cancer; Colorectal Cancer; Ovarian Cancer; Liver Cancer; Genitourinary Cancer; Gynecologic Cancer; Urinary Bladder Cancer; Leukemia; Lymphoid Leukemia; Myeloma Multiple; Prostate Cancer; Pancreas Cancer; Non-hodgkin Lymphoma; Hodgkin Lymphoma; Brain Cancer; Melanoma; Mycosis Fungoides; Kidney Cancer
University of California, Irvine
 2024-12-02 PHASE2
NCT07142291 RECRUITING
Amyotrophic Lateral Sclerosis (ALS)
PhenoNet, Inc.
 2025-11-25 PHASE2
NCT07414212 RECRUITING
Amyotrophic Lateral Sclerosis
Biogipuzkoa Health Research Institute
 2025-11-25 PHASE1; PHASE2
NCT07618715 NOT_YET_RECRUITING
Healthy Male and Female Subjects
Neurodawn Pharmaceutical Co., Ltd.
 2026-06-30 PHASE1
NCT06552260 RECRUITING
Glioblastoma; Recurrent Glioblastoma; Brain Tumor
Ugonma Chukwueke
 2025-02-19 EARLY_PHASE1
NCT07093268 NOT_YET_RECRUITING
Amyotrophic Lateral Sclerosis; Motor Neuron Disease
Brain Trust Bio
 2025-08-15 PHASE1
NCT03660917 RECRUITING
SCA7
S. Andrea Hospital
 2021-06-01 PHASE2; PHASE3
NCT06935721 RECRUITING
Healthy Male and Female Subjects
Beijing Tiantan Hospital
 2025-03-28 PHASE1
NCT06270108 UNKNOWN
Treatment-resistant Schizophrenia; Treatment-responsive Schizophrenia; Healthy Controls
King's College London
 2022-11-14 EARLY_PHASE1
NCT05508074 COMPLETED
Amyotrophic Lateral Sclerosis; ALS
InFlectis BioScience
 2022-12-02 PHASE2
NCT05292209 RECRUITING
Atrial Fibrillation Paroxysmal
University of Utah
 2022-06-15 PHASE2
NCT04745299 COMPLETED
Amyotrophic Lateral Sclerosis
Corestemchemon, Inc.
 2021-02-24 PHASE3
NCT03722680 SUSPENDED
Oxaliplatin-induced Peripheral Neuropathy
UNICANCER
 2020-10-28 PHASE2
NCT06676423 COMPLETED
Amyotrophic Lateral Sclerosis
Corestemchemon, Inc.
 2022-11-09 PHASE1
NCT02859792 UNKNOWN
Spinal Cord Injury
Assistance Publique Hopitaux De Marseille
 2019-05-27 PHASE2
NCT04326283 TERMINATED
Amyotrophic Lateral Sclerosis
Genuv Inc.
 2020-04-02 PHASE1; PHASE2
NCT04761614 COMPLETED
Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8
Ning Jin
 2021-04-02 PHASE1
NCT06270108 Recruiting
Treatment-resistant Schizophrenia|Treatment-responsive Schizophrenia|Healthy Controls
King''s College London|South London and Maudsley NHS Foundation Trust
 2022-11-14 Early Phase 1
NCT05292209 Recruiting
Atrial Fibrillation Paroxysmal
University of Utah|Ohio State University
 2022-06-15 Phase 2
NCT04950933 UNKNOWN
Amyotrophic Lateral Sclerosis
Peking University Third Hospital
 2020-06-01 PHASE2; PHASE3
NCT03039673 COMPLETED
Amyotrophic Lateral Sclerosis
Centre Hospitalier Universitaire de Nīmes
 2017-06-19 PHASE2
NCT04819438 COMPLETED
Healthy Participants
Cross Research S.A.
 2021-01-15 PHASE1
NCT04819438 Completed
Bioequivalence
Cross Research S.A.|Zambon SpA
 2021-01-15 Phase 1
NCT03347344 COMPLETED
Spinocerebellar Ataxia Type 2
Assistance Publique - Hôpitaux de Paris
 2018-01-17 PHASE3
NCT01597518 TERMINATED
Spinal Cord Injury
AOSpine North America Research Network
 2013-10 PHASE2; PHASE3
NCT01703117 COMPLETED
Alzheimer's Disease
Icahn School of Medicine at Mount Sinai
 2013-11 PHASE2
NCT02019940 COMPLETED
PTSD
Yale University
 2014-01 PHASE1
NCT03017508 COMPLETED
Social Anxiety Disorder; Performance Anxiety
Yale University
 2017-01 PHASE2; PHASE3
NCT02796755 COMPLETED
Inflammation; Fatigue
Emory University
 2016-04 PHASE4
NCT04454840 COMPLETED
Amyotrophic Lateral Sclerosis
Peking University Third Hospital
 2016-05-01 EARLY_PHASE1
NCT02859792 Recruiting
Spinal Cord Injury
Assistance Publique Hopitaux De Marseille
 2019-05-27 Phase 2
NCT03272802 UNKNOWN
Neuromuscular Diseases
Isfahan University of Medical Sciences
 2017-03-16 PHASE2; PHASE3
NCT04630444 COMPLETED
Posttraumatic Stress Disorder
Mclean Hospital
 2017-03-16 EARLY_PHASE1
NCT03679975 TERMINATED
Amyotrophic Lateral Sclerosis
Aquestive Therapeutics
 2018-04-04 PHASE2
NCT01910259 COMPLETED
Secondary Progressive Multiple Sclerosis
University College, London
 2014-12-18 PHASE2
NCT01703039 TERMINATED
Major Depressive Disorder
Brigham and Women's Hospital
 2013-01 PHASE2
NCT03457753 WITHDRAWN
ALS
Aquestive Therapeutics
 2018-03-01 PHASE2
NCT01257828 COMPLETED
Cervical Spondylotic Myelopathy
AOSpine North America Research Network
 2012-03 PHASE3
NCT02155829 COMPLETED
PTSD
Uniformed Services University of the Health Sciences
 2013-07 PHASE1; PHASE2
NCT02238626 COMPLETED
Amyotrophic Lateral Sclerosis
MediciNova
 2014-09 PHASE2
NCT04630444 Completed
Posttraumatic Stress Disorder
Mclean Hospital|Brain & Behavior Research Foundation
 2017-03-16 Early Phase 1
NCT02588677 COMPLETED
Amyotrophic Lateral Sclerosis (ALS)
AB Science
 2013-04 PHASE2; PHASE3
NCT01879241 COMPLETED
Amyotrophic Lateral Sclerosis
University of Ulm
 2013-06 PHASE2
NCT01661855 COMPLETED
Autism Spectrum Disorders
Holland Bloorview Kids Rehabilitation Hospital
 2013-09 PHASE2
NCT00523718 COMPLETED
Obsessive-compulsive Disorder; Ocd
Yale University
 2006-09 PHASE2
NCT02645461 COMPLETED
Amyotrophic Lateral Sclerosis
University of Roma La Sapienza
 2014-01
NCT01204918 COMPLETED
Depression
Yale University
 2011-06 PHASE2
NCT02136823 UNKNOWN
Chronic Spinal Cord Injury
Shirley Ryan AbilityLab
 2009-06
NCT02081027 COMPLETED
Autism Spectrum Disorders
Children's Hospital Medical Center, Cincinnati
 2013-09-19 EARLY_PHASE1
NCT00054704 TERMINATED
Bipolar Disorder
National Institute of Mental Health (NIMH)
 2003-02 PHASE2
NCT01709149 COMPLETED
Amyotrophic Lateral Sclerosis
Cytokinetics
 2012-10 PHASE2
NCT01104649 COMPLETED
Cerebellar Ataxia
S. Andrea Hospital
 2010-04 PHASE2; PHASE3
NCT01018836 TERMINATED
Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Rutgers, The State University of New Jersey
 2009-11 PHASE1
NCT01018056 COMPLETED
Tourette Syndrome
Johns Hopkins University
 2009-11 PHASE4
NCT00866840 COMPLETED
Melanoma (Skin)
Rutgers, The State University of New Jersey
 2009-04 PHASE2
NCT00501943 COMPLETED
Multiple Sclerosis
University of California, San Francisco
 2006-07 PHASE2
NCT00876772 COMPLETED
Amyotrophic Lateral Sclerosis (ALS)
Charite University, Berlin, Germany
 2011-03 PHASE2; PHASE3
NCT00805493 TERMINATED
Bipolar Disorder; Anxiety Disorders; Bipolar Affective Disorder; Bipolar Depression
National Institute of Mental Health (NIMH)
 2008-11 PHASE2
NCT01303341 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Recurrent Melanoma; Refractory Malignant Solid Neoplasm; Stage III Cutaneous Melanoma AJCC v7; Stage IIIA Cutaneous Melanoma AJCC v7; Stage IIIB Cutaneous Melanoma AJCC v7; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7
National Cancer Institute (NCI)
 2011-02-18 PHASE1
NCT01486849 COMPLETED
Amyotrophic Lateral Sclerosis
Cytokinetics
 2011-11 PHASE2
NCT01378676 COMPLETED
Amyotrophic Lateral Sclerosis
Cytokinetics
 2011-06 PHASE2
NCT01285583 COMPLETED
Amyotrophic Lateral Sclerosis
Hoffmann-La Roche
 2010-10 PHASE2; PHASE3
NCT00251303 COMPLETED
Obsessive-Compulsive Disorder; Autism Spectrum Disorder; Autism; Asperger Disorder; Developmental Disorder
National Institute of Mental Health (NIMH)
 2005-08 PHASE2
NCT00868166 COMPLETED
Amyotrophic Lateral Sclerosis
Hoffmann-La Roche
 2009-04-30 PHASE3
NCT00774423 COMPLETED
SMA
Assistance Publique - Hôpitaux de Paris
 2006-01 PHASE2; PHASE3
NCT00903214 WITHDRAWN
Breast Cancer
Barbara Ann Karmanos Cancer Institute
 2009-05 PHASE1
NCT00895752 COMPLETED
Fragile X Syndrome
Indiana University
 2009-04 PHASE4
NCT00690118 TERMINATED
Amyotrophic Lateral Sclerosis
University of Ulm
 2008-05 PHASE2
NCT00376220 COMPLETED
Bipolar Disorder
Johns Hopkins University
 2004-05 PHASE2
NCT00818389 TERMINATED
Amyotrophic Lateral Sclerosis
Massachusetts General Hospital
 2009-01 PHASE2; PHASE3
NCT01020331 COMPLETED
Amyotrophic Lateral Sclerosis
Phoenix Neurological Associates, LTD
 2005-06 PHASE2
NCT00635960 COMPLETED
Amyotrophic Lateral Sclerosis
Federico II University
 2007-03 PHASE2
NCT00544544 COMPLETED
Bipolar Depression
Mclean Hospital
 2007-06
NCT00403104 COMPLETED
Amyotrophic Lateral Sclerosis (ALS)
Ono Pharmaceutical Co., Ltd.
 2006-11 PHASE2
NCT00667901 TERMINATED
Melanoma (Skin)
University of Medicine and Dentistry of New Jersey
 2007-02 PHASE1
NCT00419003 COMPLETED
Major Depression
Baylor College of Medicine
 2006-12 PHASE4
NCT00202397 COMPLETED
Hereditary Ataxia; Multiple Sclerosis; Cerebellar Ataxia
S. Andrea Hospital
 2005-06 PHASE2
NCT00353665 COMPLETED
Amyotrophic Lateral Sclerosis
University of Lisbon
 2005-07 PHASE2; PHASE3
NCT00283309 TERMINATED
Mood; Memory Deficit
University of Texas Southwestern Medical Center
 2005-11 PHASE4
NCT00375050 COMPLETED
Schizophrenia; Schizoaffective
Yale University
 2002-05
NCT00277602 COMPLETED
Huntington Disease
Sanofi
 1999-11 PHASE3
NCT00231140 TERMINATED
Amyotrophic Lateral Sclerosis (ALS)
Charite University, Berlin, Germany
 2005-12 PHASE2
NCT00211224 TERMINATED
Multiple System Atrophy; Progressive Supranuclear Palsy
King's College London
 2000-04 PHASE3
NCT00026052 COMPLETED
Depression
National Institute of Mental Health (NIMH)
 2001-11 PHASE2
NCT00542412 COMPLETED
Amyotrophic Lateral Sclerosis
Sanofi
 2001-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-10-03)

Check the Riluzole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Riluzole acts by inactivating voltage-dependent sodium channels and inhibiting presynaptic glutamate release, thereby blocking downstream excitatory neurotransmission and intracellular excitotoxic signaling cascades. This attenuation of neuronal hyper-excitability promotes neuroprotection, providing therapeutic relevance in clinical trials for amyotrophic lateral sclerosis, spinal cord injury, and major depressive disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.