8 completed, 5 terminated, 1 suspended. 6 Phase 2, 4 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 3, Terminated 2, Suspended 1 |
| Phase 3 | 4 | Completed 2, Terminated 2 |
| Phase 1 | 2 | Completed 1, Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders STX209 (arbaclofen) - Autism Spectrum Disorders | Phase 3 | Terminated | Seaside Therapeutics, Inc. | 165 | 2011-11-01 | 2013-07-31 |
| 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 |
| A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome STX107 - Fragile X Syndrome | Phase 2 | Suspended | Seaside Therapeutics, Inc. | 16 | 2011-05-01 | 2012-12-20 |
| 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 Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107 STX107 - Fragile X Syndrome | Phase 1 | Completed | Seaside Therapeutics, Inc. | 40 | 2009-09-01 | 2010-02-08 |
| Biomarker and DNA Collection in Subjects Participating in Protocol 22003 STX209 - Fragile X Syndrome | Completed | Seaside Therapeutics, Inc. | 32 | 2009-05-01 | 2013-07-31 | |
| 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 |
| Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001 STX209 - Fragile X Syndrome | Completed | Seaside Therapeutics, Inc. | 2009-01-01 | 2013-07-31 | ||
| Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome STX209, Placebo - Fragile X Syndrome | Phase 2 | Completed | Seaside Therapeutics, Inc. | 63 | 2008-11-01 | 2013-05-06 |
Fragile X Syndrome (9) · Autism Spectrum Disorder (5) · Autistic Disorder (5) · Asperger Syndrome (1) · Mental Disorders (1)
United States (14)
Bryan King, MD, PhD (4) · Craig Erikson, MD (4) · James McCracken, MD (4) · Jeremy Veenstra-VanderWeele, MD (4) · Lawrence Ginsberg, MD (4) · Linmarie Sikich, MD (4) · Paul Wang, M.D. (4) · Raun Melmed, MD (4) · Elizabeth Berry-Kravis, MD, PhD (2) · Jonathan Picker, MBChB, PhD (2) · Lawrence Scahill, PhD (2) · Randi Hagerman, MD (2) · Shivkumar Hatti, MD (2) · Ted Brown, MD, PhD (2) · Alvaro Pascual-Leone, M.D. Ph. D. (1)