Trial · NCT02278328
MEG Study of Acute STX209 Effects in ASD
NCT02278328, Early phase 1, Completed, Timothy Roberts; results first posted 2019-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MEG Study of Acute STX209 Effects in ASD. Trials, record NCT02278328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02278328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MEG Study of Acute STX209 Effects in ASD
- NCT number
- NCT02278328
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 25 participants, actual
- Lead sponsor
- Timothy Roberts
- Conditions
- Autism Disorder
- Interventions
- STX209 (15mg), placebo, STX209 (30mg)
- First posted
- 2014-10-30
- Last updated
- 2019-10-21
- Results first posted
- 2019-10-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | M50 Latency (Left Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | The latency of the M50 auditory evoked response component arising from the left cerebral hemisphere |
| Primary | M50 Latency (Right Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | The latency of the M50 auditory evoked response component arising from the right cerebral hemisphere |
| Primary | Steady State Inter Trial Coherence (Left Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | The inter trial coherence (ITC) of auditory steady state response arising from the left cerebral hemisphere |
| Primary | Steady State Inter Trial Coherence (Right Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | The inter trial coherence (ITC) of auditory steady state response arising from the right cerebral hemisphere |
| Primary | GABA (Left Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | GABA/Cr ratio arising from a voxel in the left superior temporal gyrus |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | M50 Latency (Left Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | For placebo and 15mg dose, 1 case each was unavailable due to artifact. At 30mg dose, 2 cases were unevaluable due to artifact | ms | MEAN |
| PRIMARY | M50 Latency (Right Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | For placebo and 15mg dose, 1 case each was unavailable due to artifact. At 30mg dose, 4 cases were unevaluable due to artifact | ms | MEAN |
| PRIMARY | Steady State Inter Trial Coherence (Left Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | For placebo, 3 cases and for 15mg and 30mg doses, 1 case each was unevaluable due to artifact. | unitless | MEAN |
| PRIMARY | Steady State Inter Trial Coherence (Right Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | For placebo, 3 cases and for 15mg dose and 30mg doses, 1 case each was unevaluable due to artifact. | unitless | MEAN |
| PRIMARY | GABA (Left Hemisphere) | 1 hour per intervention followed by a 1 week washout for a total of three weeks | For placebo, 5 cases were unevaluable. For 15mg, 7 cases were unevaluable. For 30mg, 4 cases were unevaluable | ratio | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| M50 Latency (Left Hemisphere) | All Participants | Post placebo | 90.9 | Standard Deviation 13.8 | ms |
| M50 Latency (Left Hemisphere) | All Participants | Post-15mg dose | 87.4 | Standard Deviation 16.9 | ms |
| M50 Latency (Left Hemisphere) | All Participants | Post-30mg dose | 89.3 | Standard Deviation 13.5 | ms |
| M50 Latency (Right Hemisphere) | All Participants | Post-placebo | 95.1 | Standard Deviation 21.7 | ms |
| M50 Latency (Right Hemisphere) | All Participants | Post-15mg dose | 87.8 | Standard Deviation 8.6 | ms |
| M50 Latency (Right Hemisphere) | All Participants | Post-30mg dose | 93.8 | Standard Deviation 23.6 | ms |
| Steady State Inter Trial Coherence (Left Hemisphere) | All Participants | Post-placebo | .253 | Standard Deviation .134 | unitless |
| Steady State Inter Trial Coherence (Left Hemisphere) | All Participants | Post-15mg dose | .239 | Standard Deviation .111 | unitless |
| Steady State Inter Trial Coherence (Left Hemisphere) | All Participants | Post-30mg dose | .244 | Standard Deviation .116 | unitless |
| Steady State Inter Trial Coherence (Right Hemisphere) | All Participants | Post-placebo | .324 | Standard Deviation .178 | unitless |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow63
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Neuropsych Screening | STARTED | A. Placebo Then 15mg Then 30mg | 10 | |
| Neuropsych Screening | STARTED | B. 15mg Then Placebo Then 30mg | 7 | |
| Neuropsych Screening | STARTED | C. 15mg Then 30mg Then Placebo | 8 | |
| Neuropsych Screening | COMPLETED | A. Placebo Then 15mg Then 30mg | 9 | |
| Neuropsych Screening | COMPLETED | B. 15mg Then Placebo Then 30mg | 6 | |
| Neuropsych Screening | COMPLETED | C. 15mg Then 30mg Then Placebo | 6 | |
| Neuropsych Screening | NOT COMPLETED | A. Placebo Then 15mg Then 30mg | 1 | |
| Neuropsych Screening | NOT COMPLETED | B. 15mg Then Placebo Then 30mg | 1 | |
| Neuropsych Screening | NOT COMPLETED | C. 15mg Then 30mg Then Placebo | 2 | |
| First Intervention (1 Day) | STARTED | A. Placebo Then 15mg Then 30mg | 9 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events15
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 | cold symptoms / upper respiratory | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 23 | 0 |
| other | cold symptoms / upper respiratory | Respiratory, thoracic and mediastinal disorders | STX209 (15mg) | 4 | 23 | 4 |
| other | cold symptoms / upper respiratory | Respiratory, thoracic and mediastinal disorders | STX209 (30mg) | 1 | 23 | 1 |
| other | fatigue | General disorders | Placebo | 3 | 23 | 3 |
| other | fatigue | General disorders | STX209 (15mg) | 4 | 23 | 4 |
| other | fatigue | General disorders | STX209 (30mg) | 1 | 23 | 1 |
| other | increased appetite | General disorders | Placebo | 1 | 23 | 1 |
| other | increased appetite | General disorders | STX209 (15mg) | 2 | 23 | 2 |
| other | increased appetite | General disorders | STX209 (30mg) | 0 | 23 | 0 |
| other | overly energetic | General disorders | Placebo | 2 | 23 | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 23 |
| Total, all-cause mortality | STX209 (15mg) | 0 | 23 |
| Total, all-cause mortality | STX209 (30mg) | 0 | 23 |
| Total, other adverse events | Placebo | 7 | 23 |
| Total, other adverse events | STX209 (15mg) | 11 | 23 |
| Total, other adverse events | STX209 (30mg) | 4 | 23 |
| Total, serious adverse events | Placebo | 0 | 23 |
| Total, serious adverse events | STX209 (15mg) | 0 | 23 |
| Total, serious adverse events | STX209 (30mg) | 0 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02278328
GET https://conductscience.org/api/trials/v1/NCT02278328/flow?page=2