43 completed, 10 terminated, 8 recruiting, 5 unknown. 39 Phase 2, 17 Phase 3, 13 Phase 1, 6 Phase 4, 4 Early Phase 1.
Follow Riluzole: new trials by email Literature Review of Riluzole trials Research Report on Riluzole
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Cyclophosphamide in Amyotrophic Lateral Sclerosis Cyclophosphamide, Riluzole - Amyotrophic Lateral Sclerosis | Phase 2 | Not yet recruiting | Huashan Hospital | 60 | 2026-10-01 | 2026-09-22 |
| Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants Y-4 tablet, Pregabalin capsule, Riluzole tablet - Healthy Male and Female Subjects | Phase 1 | Not yet recruiting | Neurodawn Pharmaceutical Co., Ltd. | 11 | 2026-06-30 | 2026-06-01 |
| Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients Masitinib 4.5 mg/kg/day, Placebo, Riluzole (100 mg) - Amyotrophic Lateral Sclerosis (ALS) | Phase 3 | Not yet recruiting | AB Science | 412 | 2026-01-01 | 2025-10-03 |
| Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial Riluzole, Placebo - Breast Cancer, Sarcoma | Phase 2 | Recruiting | University of California, Irvine | 24 | 2025-12-23 | 2026-03-03 |
| PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS Cromolyn Sodium (34.2 mg BID), Cromolyn Sodium (17.1 mg BID), Placebo - Amyotrophic Lateral Sclerosis (ALS) | Phase 2 | Recruiting | PhenoNet, Inc. | 105 | 2025-11-25 | 2026-07-23 |
| Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS) Acetylcysteine, EH301, Riluzole - Amyotrophic Lateral Sclerosis | Phase 1 / Phase 2 | Recruiting | Biogipuzkoa Health Research Institute | 90 | 2025-11-25 | 2026-02-17 |
| Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject Y-4 tablet, Pregabalin capsule, Riluzole tablet - Healthy Male and Female Subjects | Phase 1 | Recruiting | Beijing Tiantan Hospital | 10 | 2025-03-28 | 2025-04-20 |
| Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial Riluzole, Placebo - Breast Cancer, Sarcoma | Phase 2 | Recruiting | University of California, Irvine | 75 | 2024-12-02 | 2026-07-14 |
| Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol) IFB-088 50mg/day, Placebo, Riluzole 100mg/day - Amyotrophic Lateral Sclerosis, ALS | Phase 2 | Completed | InFlectis BioScience | 51 | 2022-12-02 | 2025-10-10 |
| The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia Riluzole - Treatment-resistant Schizophrenia, Treatment-responsive Schizophrenia | Early Phase 1 | Unknown | King's College London | 288 | 2022-11-14 | 2024-03-05 |
| Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS Lenzumestrocel, Riluzole - Amyotrophic Lateral Sclerosis | Phase 1 | Completed | Corestemchemon, Inc. | 8 | 2022-11-09 | 2024-11-06 |
| RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring Riluzole 50 MG - Atrial Fibrillation Paroxysmal | Phase 2 | Recruiting | University of Utah | 78 | 2022-06-15 | 2023-11-24 |
| Riluzole in Patients With Spinocerebellar Ataxia Type 7 Riluzole, Placebo - SCA7 | Phase 2 / Phase 3 | Recruiting | S. Andrea Hospital | 34 | 2021-06-01 | 2024-12-02 |
| Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer Bevacizumab, Fluorouracil, Leucovorin Calcium - Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8 | Phase 1 | Completed | Ning Jin | 13 | 2021-04-02 | 2025-03-28 |
| Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS Lenzumestrocel, Riluzole, Placebo Comparator - Amyotrophic Lateral Sclerosis | Phase 3 | Completed | Corestemchemon, Inc. | 123 | 2021-02-24 | 2026-04-30 |
| Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients Masitinib (6.0), Riluzole, Placebo - Amyotrophic Lateral Sclerosis | Phase 3 | Recruiting | AB Science | 495 | 2021-02-02 | 2025-09-12 |
| Riluzole Orodispersible Film Replicate Bioavailability Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets - Healthy Participants | Phase 1 | Completed | Cross Research S.A. | 54 | 2021-01-15 | 2025-05-02 |
| Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy. Riluzole, Placebo Oral Tablet - Oxaliplatin-induced Peripheral Neuropathy | Phase 2 | Suspended | UNICANCER | 80 | 2020-10-28 | 2026-05-20 |
| The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules Huolingshengji Granules, Riluzole tablet - Amyotrophic Lateral Sclerosis | Phase 2 / Phase 3 | Unknown | Peking University Third Hospital | 144 | 2020-06-01 | 2021-07-08 |
| Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS) Trametinib (0.5 mg), Trametinib (1 mg), Riluzole (100 mg) - Amyotrophic Lateral Sclerosis | Phase 1 / Phase 2 | Terminated | Genuv Inc. | 23 | 2020-04-02 | 2023-05-09 |
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Amyotrophic Lateral Sclerosis (24) · Depression (5) · Bipolar Disorder (4) · Colorectal Neoplasms (4) · Depressive Disorder, Major (4) · Melanoma (4) · Spinal Cord Injuries (4) · Autism Spectrum Disorder (3) · Breast Neoplasms (3) · Motor Neuron Disease (3) · Stress Disorders, Post-Traumatic (3) · Brain Neoplasms (2) · Cerebellar Ataxia (2) · Head and Neck Neoplasms (2) · Liver Neoplasms (2)
National Institute of Mental Health (NIMH) (4) · Yale University (4) · AB Science (3) · Cytokinetics (3) · S. Andrea Hospital (3) · AOSpine North America Research Network (2) · Assistance Publique - Hôpitaux de Paris (2) · Corestemchemon, Inc. (2) · Johns Hopkins University (2) · King's College London (2) · Mclean Hospital (2) · Peking University Third Hospital (2) · Rutgers, The State University of New Jersey (2) · Sanofi (2) · University of California, Irvine (2)
United States (40) · France (9) · Canada (7) · Spain (6) · United Kingdom (6) · Italy (5) · Germany (4) · China (3) · South Korea (3) · Belgium (2) · Greece (2) · Poland (2) · Portugal (2) · Serbia (2) · Australia (1)
Jeremy Shefner, MD, PhD (3) · Alexandre Chan, PharmD, MPH (2) · James S. Goydos, MD (2) · Jinsy Andrews, MD (2) · Michael Fehlings, MD, PhD (2) · Seung Hyun Kim, MD, PhD (2) · Albert Ludolph, MD, PhD (1) · Ana Pereira, MD (1) · Andrew H Miller, MD (1) · Benjamin R Brooks, M.D. (1) · Bizhan Aarabi, MD (1) · Branko Kopjar, MD (1) · Branko Kopjar, MD, PhD (1) · Bruce G. Haffty, MD (1)
PMID 22985379, PMID 35092868, PMID 37130044, PMID 39446982, PMID 18315448, PMID 19029129, PMID 19288975, PMID 19545857, PMID 19771175, PMID 19956089, PMID 20363190, PMID 21059347, PMID 21386111, PMID 21829612, PMID 22985381, PMID 23295632, PMID 23952636, PMID 24356715, PMID 25271445, PMID 25929276, PMID 25939067, PMID 26214725, PMID 26321318, PMID 26394202, PMID 26714284, PMID 28148632, PMID 28338546, PMID 29453787, PMID 29644582, PMID 30166303, PMID 30814647, PMID 31182448, PMID 31981516, PMID 33113596, PMID 33357512, PMID 34145880, PMID 34433481, PMID 34457038, PMID 35063116, PMID 35585556, PMID 35945550, PMID 36048877, PMID 36662869, PMID 37036756, PMID 37279301, PMID 37794802, PMID 38011420, PMID 38197642, PMID 39262426, PMID 39955416
P30CA072720 (4), 2017 (2), 2015 (1), 2016 (1), M01RR000071 (1), P30CA022453 (1), R01CA149627 (1), R34MH083115 (1), R34MH085844 (1), U01CA132194 (1), U01NS049640 (1), UM1CA186716 (1)