A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's Disease
NCT02453061, Phase 2, Completed, Institut National de la Santé Et de la Recherche Médicale, France
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's Disease | ClinicalTrials.gov |
| NCT number | NCT02453061 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 100 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Institut National de la Santé Et de la Recherche Médicale, France | ClinicalTrials.gov |
| Conditions | Huntington Disease | ClinicalTrials.gov |
| Interventions | Triheptanoin oil, Placebo | ClinicalTrials.gov |
| First posted | 2015-05-25 | ClinicalTrials.gov |
| Last updated | 2026-06-03 | ClinicalTrials.gov |
| Other registries' IDs | eudract:2014-005112-42 | ClinicalTrials.gov |
Registered outcomes 27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | volumetric magnetic resonance imaging | 6 months | A decrease in the rate of caudate atrophy, using volumetric MRI | ClinicalTrials.gov |
| Secondary | motor function after 6 months | 6 months | Decrease in the progression of the UHDRS United Huntington's Disease Rating Scale after 6 months of treatment | ClinicalTrials.gov |
| Secondary | 31- Phosphorus Magnetic Resonance Spectroscopy | 3 months | An increase in the index of brain energy restoration - as defined by the difference between Pi/PCr ration during visual stimulation and the mean of the Pi/PCr ratio during rest and recovery - using 31P-MRS | ClinicalTrials.gov |
| Secondary | Caudal Atrophy | 12 months | Rate of caudate atrophy, using volumetric MRI | ClinicalTrials.gov |
| Secondary | motor function after 12 months | 12 months | Decrease in the progression of the UHDRS United Huntington's Disease Rating Scale after 12 months of treatment | ClinicalTrials.gov |
| Secondary | Patient autonomy after 6 months | 6 months | Stability of the Total Functional Capacity (TFC) after 6 months of treatment | ClinicalTrials.gov |
| Secondary | Patient autonomy after 12 months | 12 months | Stability of the Total Functional Capacity (TFC) after 12 months of treatment | ClinicalTrials.gov |
| Secondary | Sustained restoration of brain energy metabolism after 6 months | 6 months | Sustained restoration of brain energy metabolism using 31P-MRS after 6 months of treatment | ClinicalTrials.gov |
| Secondary | Sustained restoration of brain energy metabolism after 12 months | 12 months | Sustained restoration of brain energy metabolism using 31P-MRS after 12 months of treatment | ClinicalTrials.gov |
| Secondary | Symbol Digit Modalities Test after 6 months | 6 months | The benefit of triheptanoin on cognitive function will be evaluated after 6 months using a neuropsychological battery including the SDMT (Symbol Digit Modalities Test), a test of visuomotor coordination | ClinicalTrials.gov |
| Secondary | Symbol Digit Modalities Test after 12 months | 12 months | The benefit of triheptanoin on cognitive function will be evaluated after 12 months using a neuropsychological battery including the SDMT (Symbol Digit Modalities Test), a test of visuomotor coordination | ClinicalTrials.gov |
| Secondary | Stroop test after 6 months | 6 months | The benefit of triheptanoin on cognitive function will be evaluated after 6 months using a neuropsychological battery including the Stroop test, a test evaluating concentration and capacity for inhibition | ClinicalTrials.gov |
| Secondary | Stroop test after 12 months | 12 months | The benefit of triheptanoin on cognitive function will be evaluated after 12 months using a neuropsychological battery including the Stroop test, a test evaluating concentration and capacity for inhibition | ClinicalTrials.gov |
| Secondary | Trail making test after 6 months | 6 months | The benefit of triheptanoin on cognitive function will be evaluated after 6 months using a neuropsychological battery including the Trail making test, a test to evaluate mental flexibility | ClinicalTrials.gov |
| Secondary | Trail making test after 12 months | 12 months | The benefit of triheptanoin on cognitive function will be evaluated after 12 months using a neuropsychological battery including the Trail making test, a test to evaluate mental flexibility | ClinicalTrials.gov |
| Secondary | Digit span test after 6 months | 6 months | The benefit of triheptanoin on cognitive function will be evaluated after 6 months using a neuropsychological battery including the Digit span test, a test evaluating attention and working memory | ClinicalTrials.gov |
| Secondary | Digit span test after 12 months | 12 months | The benefit of triheptanoin on cognitive function will be evaluated after 12 months using a neuropsychological battery including the Digit span test, a test evaluating attention and working memory | ClinicalTrials.gov |
| Secondary | psychiatric symptoms after 3 months | 3 months | The effect of triheptanoin on psychiatric symptoms will be evaluated after 3 months with the PBA-S, an evaluation of problem behaviors associated with HD | ClinicalTrials.gov |
| Secondary | psychiatric symptoms after 6 months | 6 months | The effect of triheptanoin on psychiatric symptoms will be evaluated after 6 months with the PBA-S, an evaluation of problem behaviors associated with HD | ClinicalTrials.gov |
| Secondary | psychiatric symptoms after 9 months | 9 months | The effect of triheptanoin on psychiatric symptoms will be evaluated after 9 months with the PBA-S, an evaluation of problem behaviors associated with HD | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)