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Also known as OV101, Gaboxadol
OV101 (gaboxadol) · 3 trials · 4 indications
To evaluate the efficacy of OV101 versus placebo as assessed by the Clinical Global Impressions-Improvement-Angelman syndrome (CGI-I-AS) score at Week 12. CGIA-I-AS scores range from 1 (very much improved), to 4 (no change), to 7 (very much worse).
Number of Participants with Treatment Emergent Adverse Events
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Apparent volume of distribution during terminal phase (Vz)
| Arm | Type | Description |
|---|---|---|
| OV101 once daily (weight-based dosing) Other Name:Gaboxadol | EXPERIMENTAL | OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration |
| Placebo once daily | PLACEBO_COMPARATOR | Matching placebo,oral, provided once daily at bedtime for 12 week duration |
| OV101 (gaboxadol) Regimen 1 | EXPERIMENTAL | Once Daily |
| OV101 (gaboxadol) Regimen 2 | EXPERIMENTAL | Twice Daily |
| OV101 (gaboxadol) Regimen 3 | EXPERIMENTAL | Three Times Daily |
| Single-dose 5 mg OV101 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Gaboxadol | DRUG | OV101 versus placebo once daily at bedtime for 12 weeks |
| Placebo | DRUG | Matching placebo capsules to OV101 capsules. |
| OV101 (gaboxadol) | DRUG | OV101 (gaboxadol) |
| OV101 | DRUG | Single-dose 5 mg OV101 |
Inclusion Criteria: * Male or female and 2 to 12 years old (inclusive) at the time of informed consent * Confirmed molecular diagnosis of AS * Has a CGI-S-AS score of 3 or more at baseline. * Meets the following age-appropriate body weight criterion: 1. Subjects 2 to 3 years old must have a mini...
OV101, also known as gaboxadol, is an investigational small molecule developed by Ovid Therapeutics Inc. for rare neurodevelopmental disorders. It has been studied in Angelman Syndrome and Fragile X Syndrome. It is not approved and remains in clinical development.
OV101 has been studied as a treatment for Angelman Syndrome, a rare neurodevelopmental disorder. The primary condition studied is Angelman Syndrome, and OV101 has also been evaluated in Fragile X Syndrome. It is investigational and has not been approved for any indication.
Ovid Therapeutics Inc. (ticker: OVID) is the developer of OV101, also known as gaboxadol. The company has sponsored clinical studies of the drug in Angelman Syndrome and Fragile X Syndrome.
OV101 has been studied across Phase 1, Phase 2, and Phase 3 clinical trials. The Phase 3 study in Angelman Syndrome has completed, and the Phase 2 study in Fragile X Syndrome has completed. OV101 is investigational and has not been approved by the FDA.
OV101 has been evaluated in completed trials including NCT04106557, a Phase 3 study in Angelman Syndrome enrolling 104 participants across the United States, Australia, Germany, Israel, and the Netherlands; NCT03697161, a Phase 2 study in Fragile X Syndrome; and NCT03109756, a Phase 1 pharmacokinetic study.
Yes, OV101 is the same as gaboxadol. OV101 is the development name used by Ovid Therapeutics Inc. for gaboxadol, an investigational small molecule studied in Angelman Syndrome and Fragile X Syndrome.