Trial · NCT02996305

A Study in Adults and Adolescents With Angelman Syndrome (STARS)

NCT02996305, Phase 2, Completed, Healx AI; results first posted 2022-03-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study in Adults and Adolescents With Angelman Syndrome (STARS). Trials, record NCT02996305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02996305

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study in Adults and Adolescents With Angelman Syndrome (STARS)
NCT number: NCT02996305
Status: Completed
Phases: Phase 2
Enrollment: 88 participants, actual
Lead sponsor: Healx AI
Conditions: Angelman Syndrome
Interventions: OV101 Regimen 1, OV101 regimen 2, Placebo
First posted: 2016-12-19
Last updated: 2025-08-03
Results first posted: 2022-03-31

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Adverse Events in Placebo and Active Treatment Groups	Baseline and Week 12	Summary of Subjects Reporting at least one Treatment Emergent Adverse Event (TEAEs), Safety Set. The table below summarizes the subjects who experienced TEAEs in the study.
Primary	Incidence of Adverse Events in Placebo and Active Treatment Groups	Baseline and Week 12	The Treatment Emergent Adverse Event (TEAEs) Reported by ≥10% of Subjects in Any Treatment Group by Preferred Term, Safety Set.
Primary	Incidence of Adverse Events in Placebo and Active Treatment Groups	Baseline and Week 12	Treatment-related TEAEs (Treatment Emergent Adverse Event) in ≥ 2 Subjects in OV101 Combined, Safety Set. The incidence of TEAEs assessed as treatment-related (at least possibly related to study drug, by the Investigator). Preferred Term in the table below.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Incidence of Adverse Events in Placebo and Active Treatment Groups	Baseline and Week 12	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence of Adverse Events in Placebo and Active Treatment Groups	Baseline and Week 12	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence of Adverse Events in Placebo and Active Treatment Groups	Baseline and Week 12	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group123

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of Adverse Events in Placebo and Active Treatment Groups	Placebo	Any TEAE	25	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	OV101 QD	Any TEAE	27	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	OV101 BID	Any TEAE	25	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	Placebo	Any Mild TEAE	23	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	OV101 QD	Any Mild TEAE	23	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	OV101 BID	Any Mild TEAE	23	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	Placebo	Any Moderate TEAE	9	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	OV101 QD	Any Moderate TEAE	15	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	OV101 BID	Any Moderate TEAE	9	Participants
Incidence of Adverse Events in Placebo and Active Treatment Groups	Placebo	Any Severe TEAE	0	Participants

1 to 10 of 123Source ClinicalTrials.gov

See all 123 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	29
Overall Study	STARTED	OV101 QD	29
Overall Study	STARTED	OV101 BID	30
Overall Study	COMPLETED	Placebo	26
Overall Study	COMPLETED	OV101 QD	27
Overall Study	COMPLETED	OV101 BID	25
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	OV101 QD	2
Overall Study	NOT COMPLETED	OV101 BID	5

Source ClinicalTrials.gov

Adverse events51

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
other	Nausea	Gastrointestinal disorders	Placebo	2	29
other	Nausea	Gastrointestinal disorders	OV101 QD	0	29
other	Nausea	Gastrointestinal disorders	OV101 BID	2	29
other	General disorders and administration site conditions	Nervous system disorders	Placebo	5	29
other	General disorders and administration site conditions	Nervous system disorders	OV101 QD	3	29
other	General disorders and administration site conditions	Nervous system disorders	OV101 BID	2	29
other	Fatigue	General disorders	Placebo	2	29
other	Fatigue	General disorders	OV101 QD	1	29
other	Fatigue	General disorders	OV101 BID	2	29
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	2	29

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	29
Total, all-cause mortality	OV101 QD	0	29
Total, all-cause mortality	OV101 BID	0	29
Total, other adverse events	Placebo	13	29
Total, other adverse events	OV101 QD	18	29
Total, other adverse events	OV101 BID	19	29
Total, serious adverse events	Placebo	0	29
Total, serious adverse events	OV101 QD	1	29
Total, serious adverse events	OV101 BID	1	29

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33443117	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02996305

GET https://conductscience.org/api/trials/v1/NCT02996305/results?page=2

API reference For AI assistants