16 completed, 4 terminated, 1 not yet recruiting, 1 recruiting. 12 Phase 2, 10 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 9, Terminated 2, Unknown 1 |
| Phase 3 | 10 | Completed 7, Not yet recruiting 1, Recruiting 1, Terminated 1 |
| Phase 1 | 1 | Terminated 1 |
Follow arbaclofen placarbil: new trials by email Literature Review of arbaclofen placarbil trials Research Report on arbaclofen placarbil
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 |
|---|---|---|---|---|---|---|
| A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis Arbaclofen, Placebo - Spasticity | Phase 3 | Not yet recruiting | RVL Pharmaceuticals, Inc. | 442 | 2027-01-01 | 2025-12-03 |
| Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th Arbaclofen, Placebo - Autism Spectrum Disorders | Phase 3 | Recruiting | Hospital General Universitario Gregorio Marañon | 103 | 2025-11-20 | 2026-06-17 |
| Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion Arbaclofen, Placebo oral tablet - 16P11.2 Deletion Syndrome | Phase 2 | Unknown | Clinical Research Associates, LLC | 60 | 2022-09-01 | 2024-05-30 |
| Arbaclofen in Children and Adolescents With ASD Arbaclofen, Placebo - Autism Spectrum Disorder | Phase 2 | Completed | Celso Arango, MD, PhD | 124 | 2019-09-19 | 2023-02-08 |
| Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA) Arbaclofen, Placebo - Autism Spectrum Disorder | Phase 2 | Completed | Holland Bloorview Kids Rehabilitation Hospital | 90 | 2019-03-18 | 2025-07-16 |
| A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS Arbaclofen - Multiple Sclerosis, Spasticity, Muscle | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 323 | 2018-04-03 | 2022-08-09 |
| A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS Arbaclofen, Placebo - Multiple Sclerosis, Spasticity, Muscle | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 536 | 2018-01-28 | 2022-07-15 |
| A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder Arbaclofen Placarbil, Placebo - Alcohol Use Disorder | Phase 2 | Completed | Indivior Inc. | 18 | 2015-09-01 | 2017-01-23 |
| One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity arbaclofen - Multiple Sclerosis, Spasticity | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 150 | 2013-04-01 | 2022-04-25 |
| Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis arbaclofen, baclofen, Placebo - Spasticity, Multiple Sclerosis | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 353 | 2012-11-01 | 2022-04-25 |
| An Open Label Extension Study in Subjects With Fragile X Syndrome arbaclofen - Fragile X Syndrome | Phase 3 | Terminated | Seaside Therapeutics, Inc. | 357 | 2011-11-01 | 2013-07-31 |
| Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome arbaclofen, Placebo - Fragile X Syndrome | Phase 3 | Completed | Seaside Therapeutics, Inc. | 172 | 2011-06-01 | 2013-07-31 |
| Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders Arbaclofen - Autism Spectrum Disorders | Phase 2 | Completed | Seaside Therapeutics, Inc. | 150 | 2011-05-01 | 2013-07-31 |
| Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome arbaclofen, placebo - Fragile X Syndrome | Phase 3 | Completed | Seaside Therapeutics, Inc. | 125 | 2011-05-01 | 2013-07-31 |
| Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis Arbaclofen placarbil 15 mg BID, Placebo, Arbaclofen placarbil 30 mg BID - Multiple Sclerosis | Phase 3 | Completed | XenoPort, Inc. | 228 | 2011-05-01 | 2021-02-21 |
| TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers R-baclofen - Autism | Phase 1 | Terminated | Gonzalez-Heydrich, Joseph, M.D. | 6 | 2010-10-01 | 2015-08-21 |
| An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders arbaclofen - Autism Spectrum Disorders | Phase 2 | Terminated | Seaside Therapeutics, Inc. | 32 | 2010-02-01 | 2012-12-20 |
| An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome Arbaclofen - Fragile X Syndrome | Phase 2 | Terminated | Seaside Therapeutics, Inc. | 45 | 2009-11-01 | 2012-12-20 |
| A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) arbaclofen placarbil-Cohort 1, Placebo-Cohort 5, arbaclofen placarbil-Cohort 2 - Gastroesophageal Reflux Disease | Phase 2 | Completed | XenoPort, Inc. | 460 | 2009-09-01 | 2021-02-21 |
| Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders Arbaclofen - Autism Spectrum Disorders | Phase 2 | Completed | Seaside Therapeutics, Inc. | 32 | 2009-02-01 | 2013-06-14 |
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Autism Spectrum Disorder (7) · Autistic Disorder (5) · Fragile X Syndrome (5) · Multiple Sclerosis (5) · Muscle Spasticity (5) · Gastroesophageal Reflux (2) · 16p11.2 Deletion Syndrome (1) · Alcohol-Induced Disorders (1) · Alcoholic Intoxication (1) · Alcoholism (1) · Asperger Syndrome (1) · Back Pain (1) · Mental Disorders (1) · Social Adjustment (1)
Seaside Therapeutics, Inc. (8) · RVL Pharmaceuticals, Inc. (5) · XenoPort, Inc. (4) · Celso Arango, MD, PhD (1) · Clinical Research Associates, LLC (1) · Gonzalez-Heydrich, Joseph, M.D. (1) · Holland Bloorview Kids Rehabilitation Hospital (1) · Hospital General Universitario Gregorio Marañon (1) · Indivior Inc. (1)
United States (18) · Canada (2) · France (2) · Russia (2) · Spain (2) · Ukraine (2) · Belarus (1) · Bosnia and Herzegovina (1) · Bulgaria (1) · Croatia (1) · Moldova (1) · Poland (1) · Serbia (1) · United Kingdom (1)
Paul Wang, M.D. (3) · Bryan King, MD, PhD (2) · Craig Erikson, MD (2) · David Jacobs, MD (2) · James McCracken, MD (2) · Jeremy Veenstra-VanderWeele, MD (2) · Lawrence Ginsberg, MD (2) · Linmarie Sikich, MD (2) · Raun Melmed, MD (2) · Alvaro Pascual-Leone, M.D. Ph. D. (1) · Andre Strydom, Prof. (1) · Celso Arango, Prof. (1) · Elizabeth Berry-Kravis, MD, PhD (1) · Evdokia Anagnostou, M.D (1)
PMID 23721547, PMID 34504446, PMID 36861013, PMID 37811711, PMID 41631164, PMID 42080302
2018 (1), 2023 (1)