Trial · NCT01303406
Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)
NCT01303406, Phase 3, Completed, Santhera Pharmaceuticals; results first posted 2016-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI). Trials, record NCT01303406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01303406
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)
- NCT number
- NCT01303406
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 29 participants, actual
- Lead sponsor
- Santhera Pharmaceuticals
- Conditions
- Friedreich's Ataxia
- Interventions
- Idebenone, Placebo
- First posted
- 2011-02-24
- Last updated
- 2016-03-09
- Results first posted
- 2016-03-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone | At 2 months after study start | The primary efficacy endpoint was the comparison of the number of patients randomized to idebenone and placebo, who assessed that they received idebenone treatment. |
| Secondary | Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms | Within 2 months (i.e. Early withdrawal visit) | There was no Withdrawal due to recurrence or worsening of FRDA symptoms |
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 | Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone | At 2 months after study start | participants | NUMBER | |
| SECONDARY | Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms | Within 2 months (i.e. Early withdrawal visit) | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone | Placebo | 6 | participants | ||
| Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone | Idebenone | 8 | participants | ||
| Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms | Placebo | 0 | percentage of patients | ||
| Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms | Idebenone | 0 | percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 13 | |
| Overall Study | STARTED | Idebenone | 16 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | COMPLETED | Idebenone | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Idebenone | 1 |
Source ClinicalTrials.gov
Adverse events28
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 | Fall | Injury, poisoning and procedural complications | Placebo | 3 | 13 | |
| other | Fall | Injury, poisoning and procedural complications | Idebenone | 3 | 16 | |
| other | Fatigue | General disorders | Placebo | 0 | 13 | |
| other | Fatigue | General disorders | Idebenone | 3 | 16 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 13 | |
| other | Diarrhea | Gastrointestinal disorders | Idebenone | 2 | 16 | |
| other | Speech disorder | Nervous system disorders | Placebo | 2 | 13 | |
| other | Speech disorder | Nervous system disorders | Idebenone | 2 | 16 | |
| other | Pain | General disorders | Placebo | 1 | 13 | |
| other | Pain | General disorders | Idebenone | 1 | 16 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Idebenone | ||
| Total, other adverse events | Placebo | 9 | 13 |
| Total, other adverse events | Idebenone | 12 | 16 |
| Total, serious adverse events | Placebo | 0 | 13 |
| Total, serious adverse events | Idebenone | 1 | 16 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Idebenone vs Placebo: Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone | Trial comparisons |
| Idebenone vs Placebo: 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/NCT01303406
GET https://conductscience.org/api/trials/v1/NCT01303406/events?page=2