Trial · NCT00824512
Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia
NCT00824512, Phase 2, Completed, Ipsen; results first posted 2013-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia. Trials, record NCT00824512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00824512
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia
- NCT number
- NCT00824512
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Friedreich Ataxia
- Interventions
- EGb 761 120 mg, Placebo
- First posted
- 2009-01-16
- Last updated
- 2020-04-07
- Other registries' IDs
- eudract:2007-005371-34
- Results first posted
- 2013-05-21
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Creatine Rephosphorylation Rate Post Exercise | Baseline (Week 0) to Week 12 | Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH. |
| Secondary | Peak Post Exercise Perfusion | Baseline (Week 0) to Week 12 | Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging. |
| Secondary | Time to Peak Perfusion | Baseline (Week 0) to Week 12 | |
| Secondary | Perfusion-time Integral During the First 9 Minutes Post Exercise. | Baseline (Week 0) to Week 12 | The integral of 'peak perfusion' over a period of 9 minutes post exercise. |
| Secondary | Muscle Reoxygenation Rate Post Exercise. | Baseline (Week 0) to Week 12 | Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy. |
| Secondary | Muscle Trophicity: Maximum Cross Section of Muscle | Baseline (Week 0) to Week 12 | Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm\^2) |
| Secondary | Developed Force During the Exercise Bout | Baseline (Week 0) to Week 12 | Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy |
| Secondary | Normalised Work Developed During the Exercise | Baseline (Week 0) to Week 12 | Normalised work developed during the exercise was derived as Work developed during the exercise/(\[60 X Maximum cross section of muscle\]-1100). Normalised work measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy. |
| Secondary | Metabolism Efficacy Index | Baseline (Week 0) to Week 12 | The metabolism efficacy index was derived as Normalised work x creatine phosphorylation rate (sec-1). \[Normalised work was derived as Work developed during the exercise/(60 X Maximum cross section of muscle-1100)\]. Greater values of Metabolism Efficacy index indicate improvement in skeletal muscle energetics while lower values indicate the reverse. Negative values obtained using the formula indicated severe levels of muscle weakness. |
| Secondary | International Cooperative Ataxia Rating Scale [ICARS] (Total Score) | Baseline (Week 0) to Week 12 | The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales (i.e. Posture and gait disturbances, Kinetic functions, Speech disorders, \& Oculomotor disorders). Scores for each subscale quantify the extent of ataxia in each clinically important area and subscale scores are also summed to give a total score ranging from 0 to 100, with 100 indicative of the most severely affected outcome. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Creatine Rephosphorylation Rate Post Exercise | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | pH per second | MEDIAN |
| SECONDARY | Peak Post Exercise Perfusion | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | ml/mn/100 g of tissue | MEDIAN |
| SECONDARY | Time to Peak Perfusion | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | seconds | MEDIAN |
| SECONDARY | Perfusion-time Integral During the First 9 Minutes Post Exercise. | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | mL/100 g of tissue | MEDIAN |
| SECONDARY | Muscle Reoxygenation Rate Post Exercise. | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | per second | MEDIAN |
| SECONDARY | Muscle Trophicity: Maximum Cross Section of Muscle | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | cm^2 | MEDIAN |
| SECONDARY | Developed Force During the Exercise Bout | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | Joules | MEDIAN |
| SECONDARY | Normalised Work Developed During the Exercise | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | Joules/cm^2 | MEDIAN |
| SECONDARY | Metabolism Efficacy Index | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | per second | MEDIAN |
| SECONDARY | International Cooperative Ataxia Rating Scale [ICARS] (Total Score) | Baseline (Week 0) to Week 12 | Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population. | score on a scale | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Creatine Rephosphorylation Rate Post Exercise | EGb 761® 120 mg | Baseline (Week 0) | 0.024 | Full Range 0.013 to 0.037 | pH per second |
| Creatine Rephosphorylation Rate Post Exercise | Placebo | Baseline (Week 0) | 0.029 | Full Range 0.018 to 0.040 | pH per second |
| Creatine Rephosphorylation Rate Post Exercise | EGb 761® 120 mg | Week 12 | 0.022 | Full Range 0.015 to 0.043 | pH per second |
| Creatine Rephosphorylation Rate Post Exercise | Placebo | Week 12 | 0.029 | Full Range 0.014 to 0.035 | pH per second |
| Creatine Rephosphorylation Rate Post Exercise | EGb 761® 120 mg | Change from Baseline (Week 0) to Week 12 | 0.001 | Full Range -0.009 to 0.009 | pH per second |
| Creatine Rephosphorylation Rate Post Exercise | Placebo | Change from Baseline (Week 0) to Week 12 | 0.000 | Full Range -0.013 to 0.005 | pH per second |
| Peak Post Exercise Perfusion | EGb 761® 120 mg | Baseline (Week 0) | 54.30 | Full Range 33.9 to 91.0 | ml/mn/100 g of tissue |
| Peak Post Exercise Perfusion | Placebo | Baseline (Week 0) | 51.80 | Full Range 10.8 to 81.4 | ml/mn/100 g of tissue |
| Peak Post Exercise Perfusion | EGb 761® 120 mg | Week 12 | 58.80 | Full Range 37.6 to 88.8 | ml/mn/100 g of tissue |
| Peak Post Exercise Perfusion | Placebo | Week 12 | 46.60 | Full Range 30.7 to 63.1 | ml/mn/100 g of tissue |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EGb 761® 120 mg | 11 | |
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | COMPLETED | EGb 761® 120 mg | 11 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | EGb 761® 120 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events44
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 | Nasopharyngitis | Infections and infestations | EGb 761® 120 mg | 2 | 11 | 2 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 0 | 11 | 0 |
| other | Influenza | Infections and infestations | EGb 761® 120 mg | 1 | 11 | 1 |
| other | Influenza | Infections and infestations | Placebo | 1 | 11 | 1 |
| other | Gastroenteritis viral | Infections and infestations | EGb 761® 120 mg | 1 | 11 | 1 |
| other | Gastroenteritis viral | Infections and infestations | Placebo | 0 | 11 | 0 |
| other | Gastroenteritis | Infections and infestations | EGb 761® 120 mg | 0 | 11 | 0 |
| other | Gastroenteritis | Infections and infestations | Placebo | 1 | 11 | 1 |
| other | Headache | Nervous system disorders | EGb 761® 120 mg | 3 | 11 | 3 |
| other | Headache | Nervous system disorders | Placebo | 2 | 11 | 2 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EGb 761® 120 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | EGb 761® 120 mg | 8 | 11 |
| Total, other adverse events | Placebo | 7 | 11 |
| Total, serious adverse events | EGb 761® 120 mg | 1 | 11 |
| Total, serious adverse events | Placebo | 1 | 11 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| EGb 761® 120 mg vs Placebo: serious adverse events |
Source Trial comparisons
Tests1
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 |
|---|---|
| Choice Reaction Time | Secondary outcome |
Source ConductCognition
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/NCT00824512
GET https://conductscience.org/api/trials/v1/NCT00824512/registered?page=2