Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
arbaclofen · 2 trials · 1 indication
This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal
| Arm | Type | Description |
|---|---|---|
| STX209 5 mg BID | ACTIVE_COMPARATOR | - |
| STX209 10 mg BID | ACTIVE_COMPARATOR | - |
| STX209 10 mg TID | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arbaclofen | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| arbaclofen | DRUG | 5 mg bid |
| Placebo | DRUG | tid |
Inclusion Criteria: * Molecular documentation of the full FMR1 mutation * Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening. * Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been sei...
Arbaclofen is an investigational small molecule being developed for the treatment of Fragile X Syndrome, a rare genetic condition. It is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients.
Arbaclofen is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Fragile X Syndrome, though the drug remains investigational and is not yet approved.
Arbaclofen is in Phase 3 clinical development for Fragile X Syndrome. Two Phase 3 trials have been completed, with a total of 297 participants enrolled. The drug is still investigational and has not received FDA approval, as it remains under evaluation for safety and efficacy.
Arbaclofen has completed two Phase 3 clinical trials. NCT01282268 enrolled 125 adolescents and adults with Fragile X Syndrome, while NCT01325220 enrolled 172 children aged 5 years and older. Both trials were randomized, double-blind, and placebo-controlled, and both have been completed.
Yes, arbaclofen is also known as STX209. The clinical trials NCT01282268 and NCT01325220 both refer to the drug as STX209 (arbaclofen) in their titles, confirming that these names refer to the same investigational compound being studied for Fragile X Syndrome.
Arbaclofen is a small molecule being studied for Fragile X Syndrome. The specific molecular target or mechanism of action has not been disclosed in the available clinical trial information, so its precise mode of action remains under investigation as part of ongoing research.