Trial · NCT03697161
A Study of OV101 in Individuals With Fragile X Syndrome
NCT03697161, Phase 2, Completed, Ovid Therapeutics Inc.; results first posted 2024-01-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of OV101 in Individuals With Fragile X Syndrome. Trials, record NCT03697161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03697161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of OV101 in Individuals With Fragile X Syndrome
- NCT number
- NCT03697161
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Ovid Therapeutics Inc.
- Conditions
- Fragile X Syndrome (FXS)
- Interventions
- OV101 (gaboxadol)
- First posted
- 2018-10-05
- Last updated
- 2024-01-23
- Results first posted
- 2024-01-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Week 12 | Number of Participants with Treatment Emergent Adverse Events |
| Other | Clinical Global Impressions- Improvement (CGI-I) | Week 12 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Week 12 | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Clinical Global Impressions- Improvement (CGI-I) | Week 12 |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg QD) | Any serious TEAE | 0 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg BID) | Any serious TEAE | 0 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg TID) | Any serious TEAE | 0 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg QD) | Any study medication-related TEAE | 1 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg BID) | Any study medication-related TEAE | 5 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg TID) | Any study medication-related TEAE | 2 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg QD) | Any study medication-related serious TEAE | 0 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg BID) | Any study medication-related serious TEAE | 0 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg TID) | Any study medication-related serious TEAE | 0 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | OV101 (Gaboxadol) (5 mg QD) | Severity of TEAE Mild | 1 | participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OV101 (Gaboxadol) Regimen 1 | 7 | |
| Overall Study | STARTED | OV101 (Gaboxadol) Regimen 2 | 8 | |
| Overall Study | STARTED | OV101 (Gaboxadol) Regimen 3 | 8 | |
| Overall Study | COMPLETED | OV101 (Gaboxadol) Regimen 1 | 6 | |
| Overall Study | COMPLETED | OV101 (Gaboxadol) Regimen 2 | 7 | |
| Overall Study | COMPLETED | OV101 (Gaboxadol) Regimen 3 | 7 | |
| Overall Study | NOT COMPLETED | OV101 (Gaboxadol) Regimen 1 | 1 | |
| Overall Study | NOT COMPLETED | OV101 (Gaboxadol) Regimen 2 | 1 | |
| Overall Study | NOT COMPLETED | OV101 (Gaboxadol) Regimen 3 | 1 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NASOPHARYNGITIS | Infections and infestations | OV101 (5 mg QD) | 0 | 7 | 0 |
| other | NASOPHARYNGITIS | Infections and infestations | OV101 (5 mg BID) | 1 | 8 | 4 |
| other | NASOPHARYNGITIS | Infections and infestations | OV101 (5 mg TID) | 1 | 8 | 6 |
| other | IRRITABILITY | Psychiatric disorders | OV101 (5 mg QD) | 0 | 7 | 0 |
| other | IRRITABILITY | Psychiatric disorders | OV101 (5 mg BID) | 1 | 8 | 1 |
| other | IRRITABILITY | Psychiatric disorders | OV101 (5 mg TID) | 1 | 8 | 1 |
| other | DIARRHOEA | Gastrointestinal disorders | OV101 (5 mg QD) | 0 | 7 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | OV101 (5 mg BID) | 0 | 8 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | OV101 (5 mg TID) | 2 | 8 | 2 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | OV101 (5 mg QD) | 0 | 7 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OV101 (5 mg QD) | 0 | 7 |
| Total, all-cause mortality | OV101 (5 mg BID) | 0 | 8 |
| Total, all-cause mortality | OV101 (5 mg TID) | 0 | 8 |
| Total, other adverse events | OV101 (5 mg QD) | 1 | 7 |
| Total, other adverse events | OV101 (5 mg BID) | 8 | 8 |
| Total, other adverse events | OV101 (5 mg TID) | 8 | 8 |
| Total, serious adverse events | OV101 (5 mg QD) | 0 | 7 |
| Total, serious adverse events | OV101 (5 mg BID) | 0 | 8 |
| Total, serious adverse events | OV101 (5 mg TID) | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34690787 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03697161
GET https://conductscience.org/api/trials/v1/NCT03697161/results?page=2