Trial · NCT03888664
Open Trail of γIFN for Friedreich Ataxia
NCT03888664, Phase 2, Completed, IRCCS Eugenio Medea
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Trail of γIFN for Friedreich Ataxia. Trials, record NCT03888664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03888664
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Trail of γIFN for Friedreich Ataxia
- NCT number
- NCT03888664
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- IRCCS Eugenio Medea
- Conditions
- Friedreich Ataxia
- Interventions
- gamma interferon
- First posted
- 2019-03-25
- Last updated
- 2020-02-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | number and severity of adverse drug reactions | 12 months | number of AE and SAE reported by treated patients along the study. Safety of γIFN treatment given for 6 months at final dose of 200 mcg three times weekly in FRDA patients |
| Secondary | Changes in SARA score | 18 months | changes in scores at the SARA scale assessed at various time points (from 6 moths before treatment start to 6 months after treatment stop) for each patient |
| Secondary | change in BOLD signal obtained during the selective motor task (finger tapping) | 18 months | intensity of BOLD signal in FRDA patients performing the finger tapping protocol at least 6 months prior to treatment start, at treatmenet start, after 6 months of treatment and 6 months after treatment discontinuation |
| Secondary | Changes in RNFL thickness | 12 months | Mean Thickness of RNFL and thickness in the 4 quadrants as resulting from OCT exam |
| Secondary | Thickness of ventricular wall as measured by Ecocardiogram (EcoCG) | 12 months | changes in ventricular and interventricular walls thickness (mm) at various time points for each patient |
| Secondary | - Frataxin levels in cell lysates prepared from peripheral blood mononuclear cells (PBMC) | 12 monhts | changes in Frataxin levels (intensity of frataxin band at western blot) associated with treatment |
| Secondary | - Changes in quality of life measure. | 12 months | scores at SF36 assessed along time in each patient |
| Secondary | CHANGES in FA in the cerebellar white matter, the long and the commissural tracts | 18 months | Fractional anysotropy values at selected ROI as measured at various time points in each patient |
| Secondary | Changes in measure of disability | 12 months | changes in WHO-DAS 2.0 scores recorede along time |
| Secondary | Changes in Mean diffusivity (MD) in the cerebellar white matter, the long and the commissural tracts | 18 months | MD values at selected ROI as measured at various time points in each patient |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT03888664
GET https://conductscience.org/api/trials/v1/NCT03888664/registered