Trial · NCT02660112
(+) Epicatechin to Treat Friedreich's Ataxia
NCT02660112, Phase 2, Completed, Ralitza Gavrilova; results first posted 2019-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. (+) Epicatechin to Treat Friedreich's Ataxia. Trials, record NCT02660112. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02660112
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- (+) Epicatechin to Treat Friedreich's Ataxia
- NCT number
- NCT02660112
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Ralitza Gavrilova
- Conditions
- Friedreich's Ataxia
- Interventions
- (+)-Epicatechin
- First posted
- 2016-01-21
- Last updated
- 2019-12-05
- Results first posted
- 2019-12-05
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 Friedreich Ataxia Rating Scale (FARS) Composite Score | Baseline, 24 weeks | The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, an activities of daily living subscale and a neurological subscale. This scale also includes the 8m walk at maximum speed (8MW), the 9-hole peg test (9HPT), PATA rate (assesses speech speed by repetitions of pronouncing "PaTa" ) and low-contrast letter acuity. FARS is made up of a measure of ataxia, an activities of daily living subscale and a neurological subscale. This scale also includes the 8m walk at maximum speed (8MW), the 9-hole peg test (9HPT), PATA rate and low-contrast letter acuity. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability. |
| Primary | Change in Ventricular Hypertrophy as Shown on Cardiac MRI | Baseline, 24 weeks | Left ventricular mass and left ventricular (LV) mass indexed to body surface area estimated by Left Ventricle (LV)cavity dimension and wall thickness at end-diastole. Normal values of LV mass indexed to body surface area are found to be 49-115 gL/m2 in men and 43-95 g/m2 in women. |
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 Friedreich Ataxia Rating Scale (FARS) Composite Score | Baseline, 24 weeks | One subject did not complete week 24 questionnaire | score on a scale | MEAN |
| PRIMARY | Change in Ventricular Hypertrophy as Shown on Cardiac MRI | Baseline, 24 weeks | mL/m2 | MEAN |
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 Friedreich Ataxia Rating Scale (FARS) Composite Score | (+)-Epicatechin | 55.0 | Standard Deviation 18.72 | score on a scale | |
| Change in Ventricular Hypertrophy as Shown on Cardiac MRI | (+)-Epicatechin | 55.9 | Standard Deviation 9.49 | mL/m2 |
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 | (+)-Epicatechin | 10 | |
| Overall Study | COMPLETED | (+)-Epicatechin | 10 | |
| Overall Study | NOT COMPLETED | (+)-Epicatechin | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Transient worsening of migraine | Nervous system disorders | (+)-Epicatechin | 3 | 10 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (+)-Epicatechin | 0 | 10 |
| Total, other adverse events | (+)-Epicatechin | 3 | 10 |
| Total, serious adverse events | (+)-Epicatechin | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32677106 | 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.
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/NCT02660112
GET https://conductscience.org/api/trials/v1/NCT02660112/registered