Trial · NCT02036853
An Open-Label Trial of Triheptanoin in Patients With Glucose Transporter Type-1 Deficiency Syndrome
NCT02036853, Phase 2, Completed, Adrian Lacy; results first posted 2021-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label Trial of Triheptanoin in Patients With Glucose Transporter Type-1 Deficiency Syndrome. Trials, record NCT02036853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02036853
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Trial of Triheptanoin in Patients With Glucose Transporter Type-1 Deficiency Syndrome
- NCT number
- NCT02036853
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Adrian Lacy
- Conditions
- Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)
- Interventions
- Triheptanoin
- First posted
- 2014-01-15
- Last updated
- 2021-01-28
- Results first posted
- 2021-01-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reported Change in Seizures Frequency From Baseline at 13 Weeks | Baseline and 13 weeks | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. |
| Primary | Reported Change in Seizures Frequency From Baseline at 26 Weeks | Baseline and 26 weeks | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. The table below represents the change in seizure frequency from baseline for each time point. |
| Primary | Reported Change in Seizures Frequency From Baseline at 1 Year | Baseline and one yr | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. The table below represents the change in seizure frequency from baseline for each time point. |
| Primary | Reported Change in Seizures Frequency From Baseline at 18 Months | Baseline and 18 months | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. The table below represents the change in seizure frequency from baseline for each time point. |
| Primary | Reported Change in Seizures Frequency From Baseline at 2 Years | Baseline and two yrs | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. The table below represents the change in seizure frequency from baseline for each time point. |
| Primary | Reported Change in Seizures Frequency From Baseline at 3 Years | Baseline and three yrs | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. The table below represents the change in seizure frequency from baseline for each time point. |
| Primary | Reported Change in Seizure Frequency From Baseline at 4 Years | Baseline and four yrs | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. The table below represents the change in seizure frequency from baseline for each time point. |
| Primary | Reported Change in Seizure Frequency From Baseline at 5 Years | Baseline and five yrs | A seizure diary was used to track date, type, number, and unusual presentation of seizures. Subjects were given a seizure diary at screening to record daily seizure activity for incremental periods of time. Unless otherwise waived, subjects complete this form daily during the screening period and for two weeks prior to each subsequent study visit. The table below represents the change in seizure frequency from baseline for each time point. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reported Change in Seizures Frequency From Baseline at 13 Weeks | Baseline and 13 weeks | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | MEAN |
| PRIMARY | Reported Change in Seizures Frequency From Baseline at 26 Weeks | Baseline and 26 weeks | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | MEAN |
| PRIMARY | Reported Change in Seizures Frequency From Baseline at 1 Year | Baseline and one yr | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | MEAN |
| PRIMARY | Reported Change in Seizures Frequency From Baseline at 18 Months | Baseline and 18 months | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | MEAN |
| PRIMARY | Reported Change in Seizures Frequency From Baseline at 2 Years | Baseline and two yrs | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | MEAN |
| PRIMARY | Reported Change in Seizures Frequency From Baseline at 3 Years | Baseline and three yrs | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | MEAN |
| PRIMARY | Reported Change in Seizure Frequency From Baseline at 4 Years | Baseline and four yrs | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | MEAN |
| PRIMARY | Reported Change in Seizure Frequency From Baseline at 5 Years | Baseline and five yrs | The number analyzed over time reflects both subject drop out and subjects that failed to record seizure counts during the respective reporting period. | seizures/two weeks | 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 |
|---|---|---|---|---|---|
| Reported Change in Seizures Frequency From Baseline at 13 Weeks | Schedule A | 4.4 | Full Range -10 to 22 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 13 Weeks | Schedule B | 189.5 | Full Range -228 to 2420 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 26 Weeks | Schedule A | -5.6 | Full Range -25 to 8 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 26 Weeks | Schedule B | -78 | Full Range -265 to 0 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 1 Year | Schedule A | -6.5 | Full Range -15 to 0 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 1 Year | Schedule B | -110.5 | Full Range -331 to 0 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 18 Months | Schedule A | -5.8 | Full Range -20 to 2 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 18 Months | Schedule B | -112.7 | Full Range -340 to 3 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 2 Years | Schedule A | -6 | Full Range -39 to 5 | seizures/two weeks | |
| Reported Change in Seizures Frequency From Baseline at 2 Years | Schedule B | -61.25 | Full Range -245 to 0 | seizures/two weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Schedule A | 6 | |
| Overall Study | STARTED | Schedule B | 14 | |
| Overall Study | COMPLETED | Schedule A | 6 | |
| Overall Study | COMPLETED | Schedule B | 8 | |
| Overall Study | NOT COMPLETED | Schedule A | 0 | |
| Overall Study | NOT COMPLETED | Schedule B | 6 |
Source ClinicalTrials.gov
Adverse events172
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 | Otalgia | Ear and labyrinth disorders | Schedule A | 1 | 6 | 1 |
| other | Otalgia | Ear and labyrinth disorders | Schedule B | 1 | 14 | 1 |
| other | Hirsutism | Endocrine disorders | Schedule A | 1 | 6 | 1 |
| other | Hirsutism | Endocrine disorders | Schedule B | 0 | 14 | 0 |
| other | Conjuctivitis | Eye disorders | Schedule A | 0 | 6 | 0 |
| other | Conjuctivitis | Eye disorders | Schedule B | 1 | 14 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Schedule A | 1 | 6 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Schedule B | 8 | 14 | 8 |
| other | Abdominal Distention | Gastrointestinal disorders | Schedule A | 0 | 6 | 0 |
| other | Abdominal Distention | Gastrointestinal disorders | Schedule B | 1 | 14 | 1 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Schedule A | 0 | 6 |
| Total, all-cause mortality | Schedule B | 0 | 14 |
| Total, other adverse events | Schedule A | 6 | 6 |
| Total, other adverse events | Schedule B | 14 | 14 |
| Total, serious adverse events | Schedule A | 0 | 6 |
| Total, serious adverse events | Schedule B | 1 | 14 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Schedule A vs Schedule B: deaths from any cause | Trial comparisons |
| Schedule A vs Schedule B: serious adverse events | Trial comparisons |
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/NCT02036853
GET https://conductscience.org/api/trials/v1/NCT02036853/events?page=2