Trial · NCT00004418
Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
NCT00004418, Phase 2, Terminated, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.; results first posted 2020-10-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy. Trials, record NCT00004418. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004418
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
- NCT number
- NCT00004418
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Conditions
- Adrenoleukodystrophy
- Interventions
- glyceryl trierucate/glyceryl trioleate
- First posted
- 1999-10-19
- Last updated
- 2020-10-23
- Results first posted
- 2020-10-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Very Long Chain Fatty Acids (VLCFA) Blood Levels | Baseline, an average of 10 years, up to age 13 | we will assess the change in very long-chain fatty acids as determined by reduction of blood level baseline C26:0 level. |
| Secondary | Number of Participants With T2 MRI Abnormality | 10 years | We used MRI to determine the number of participants with T2 MRI abnormality indicating childhood Adrenoleukodystrophy (ALD). |
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 | Change From Baseline in Very Long Chain Fatty Acids (VLCFA) Blood Levels | Baseline, an average of 10 years, up to age 13 | mcg/mL | MEAN | |
| SECONDARY | Number of Participants With T2 MRI Abnormality | 10 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Very Long Chain Fatty Acids (VLCFA) Blood Levels | GTO/GTE Treatment | 0.41 | Full Range 0.05 to 0.41 | mcg/mL | |
| Number of Participants With T2 MRI Abnormality | GTO/GTE Treatment | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GTO/GTE Treatment | 126 | |
| Overall Study | COMPLETED | GTO/GTE Treatment | 126 | |
| Overall Study | NOT COMPLETED | GTO/GTE Treatment | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Thrombocytopenia | Blood and lymphatic system disorders | GTO/GTE Treatment | 1 | 126 | 1 |
| other | Elevation in liver function tests | Hepatobiliary disorders | GTO/GTE Treatment | 0 | 126 | 0 |
| serious | Death | Endocrine disorders | GTO/GTE Treatment | 1 | 126 | 1 |
| serious | adrenal crisis | Endocrine disorders | GTO/GTE Treatment | 2 | 126 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GTO/GTE Treatment | 1 | 126 |
| Total, other adverse events | GTO/GTE Treatment | 1 | 126 |
| Total, serious adverse events | GTO/GTE Treatment | 3 | 126 |
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/NCT00004418
GET https://conductscience.org/api/trials/v1/NCT00004418/registered