Trial Outcomes & Findings for Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia (NCT NCT00824512)
NCT ID: NCT00824512
Last Updated: 2020-04-07
Results Overview
Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.
COMPLETED
PHASE2
22 participants
Baseline (Week 0) to Week 12
2020-04-07
Participant Flow
Patients were recruited at a single centre investigational site in France.
Overall number of baseline participants differs from number of participants who started as efficacy analysis was performed on modified Intention-To-Treat (mITT) population (i.e. 21 patients). 1 patient in the placebo group did not meet the primary criteria and thus excluded from the analysis. No patient was excluded from the safety population.
Participant milestones
| Measure |
EGb 761® 120 mg
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia
Baseline characteristics by cohort
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12-15 years
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
16-22 years
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Duration since first symptoms
|
8.1 years
n=5 Participants
|
7.7 years
n=7 Participants
|
7.8 years
n=5 Participants
|
|
Number of repeats of Guanine Adenine Adenine (GAA) sequence
|
700 GAA sequence repetitions
n=5 Participants
|
810 GAA sequence repetitions
n=7 Participants
|
700 GAA sequence repetitions
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Creatine Rephosphorylation Rate Post Exercise
Baseline (Week 0)
|
0.024 pH per second
Interval 0.013 to 0.037
|
0.029 pH per second
Interval 0.018 to 0.04
|
|
Creatine Rephosphorylation Rate Post Exercise
Week 12
|
0.022 pH per second
Interval 0.015 to 0.043
|
0.029 pH per second
Interval 0.014 to 0.035
|
|
Creatine Rephosphorylation Rate Post Exercise
Change from Baseline (Week 0) to Week 12
|
0.001 pH per second
Interval -0.009 to 0.009
|
0.000 pH per second
Interval -0.013 to 0.005
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Peak Post Exercise Perfusion
Baseline (Week 0)
|
54.30 ml/mn/100 g of tissue
Interval 33.9 to 91.0
|
51.80 ml/mn/100 g of tissue
Interval 10.8 to 81.4
|
|
Peak Post Exercise Perfusion
Week 12
|
58.80 ml/mn/100 g of tissue
Interval 37.6 to 88.8
|
46.60 ml/mn/100 g of tissue
Interval 30.7 to 63.1
|
|
Peak Post Exercise Perfusion
Change from Baseline (Week 0) to Week 12
|
3.60 ml/mn/100 g of tissue
Interval -29.5 to 31.2
|
-1.55 ml/mn/100 g of tissue
Interval -20.9 to 23.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Time to Peak Perfusion
Baseline (Week 0)
|
38.30 seconds
Interval 0.8 to 269.3
|
58.55 seconds
Interval 5.3 to 317.3
|
|
Time to Peak Perfusion
Week 12
|
39.80 seconds
Interval 0.8 to 119.3
|
76.55 seconds
Interval 0.8 to 384.8
|
|
Time to Peak Perfusion
Change from Baseline (Week 0) to Week 12
|
8.50 seconds
Interval -267.0 to 94.5
|
14.25 seconds
Interval -232.5 to 274.5
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The integral of 'peak perfusion' over a period of 9 minutes post exercise.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Perfusion-time Integral During the First 9 Minutes Post Exercise.
Baseline (Week 0)
|
166.90 mL/100 g of tissue
Interval 83.6 to 353.0
|
157.20 mL/100 g of tissue
Interval 11.8 to 373.0
|
|
Perfusion-time Integral During the First 9 Minutes Post Exercise.
Week 12
|
191.60 mL/100 g of tissue
Interval 86.1 to 417.3
|
185.70 mL/100 g of tissue
Interval 22.0 to 396.7
|
|
Perfusion-time Integral During the First 9 Minutes Post Exercise.
Change from Baseline (Week 0) to Week 12
|
-5.20 mL/100 g of tissue
Interval -138.2 to 237.4
|
0.05 mL/100 g of tissue
Interval -156.7 to 212.9
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Muscle Reoxygenation Rate Post Exercise.
Baseline (Week 0)
|
0.0870 per second
Interval 0.035 to 0.156
|
0.0540 per second
Interval 0.024 to 0.123
|
|
Muscle Reoxygenation Rate Post Exercise.
Week 12
|
0.0580 per second
Interval 0.03 to 0.114
|
0.0620 per second
Interval 0.021 to 0.087
|
|
Muscle Reoxygenation Rate Post Exercise.
Change from Baseline (Week 0) to Week 12
|
-0.0350 per second
Interval -0.124 to 0.039
|
-0.0035 per second
Interval -0.058 to 0.049
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm\^2)
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Muscle Trophicity: Maximum Cross Section of Muscle
Baseline (Week 0)
|
28.10 cm^2
Interval 16.6 to 33.1
|
28.95 cm^2
Interval 23.4 to 42.4
|
|
Muscle Trophicity: Maximum Cross Section of Muscle
Week 12
|
26.8 cm^2
Interval 16.7 to 33.2
|
29.85 cm^2
Interval 24.0 to 42.9
|
|
Muscle Trophicity: Maximum Cross Section of Muscle
Change from Baseline (Week 0) to Week 12
|
0.10 cm^2
Interval -1.3 to 0.7
|
0.55 cm^2
Interval -2.1 to 2.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Developed Force During the Exercise Bout
Baseline (Week 0)
|
305.30 Joules
Interval 177.0 to 822.9
|
358.10 Joules
Interval 207.2 to 1172.8
|
|
Developed Force During the Exercise Bout
Week 12
|
277.50 Joules
Interval 136.9 to 750.9
|
354.35 Joules
Interval 200.9 to 1002.1
|
|
Developed Force During the Exercise Bout
Change from Baseline (Week 0) to Week 12
|
-32.40 Joules
Interval -146.9 to 56.6
|
19.20 Joules
Interval -191.8 to 109.8
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
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.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Normalised Work Developed During the Exercise
Baseline (Week 0)
|
12.07 Joules/cm^2
Interval 6.3 to 26.0
|
12.00 Joules/cm^2
Interval 8.6 to 30.5
|
|
Normalised Work Developed During the Exercise
Week 12
|
9.23 Joules/cm^2
Interval 7.6 to 24.0
|
11.53 Joules/cm^2
Interval 6.1 to 25.7
|
|
Normalised Work Developed During the Exercise
Change from Baseline (Week 0) to Week 12
|
-1.03 Joules/cm^2
Interval -6.3 to 2.6
|
0.47 Joules/cm^2
Interval -4.8 to 4.6
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
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.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Metabolism Efficacy Index
Baseline (Week 0)
|
0.0180 per second
Interval -0.042 to 0.038
|
0.0150 per second
Interval 0.01 to 0.029
|
|
Metabolism Efficacy Index
Week 12
|
0.0130 per second
Interval -0.021 to 0.042
|
0.0145 per second
Interval 0.007 to 0.028
|
|
Metabolism Efficacy Index
Change from Baseline (Week 0) to Week 12
|
0.0010 per second
Interval -0.021 to 0.021
|
-0.0010 per second
Interval -0.007 to 0.001
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
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.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
International Cooperative Ataxia Rating Scale [ICARS] (Total Score)
Baseline (Week 0)
|
35 score on a scale
Interval 21.0 to 54.0
|
26.5 score on a scale
Interval 20.0 to 58.0
|
|
International Cooperative Ataxia Rating Scale [ICARS] (Total Score)
Week 12
|
33.0 score on a scale
Interval 26.0 to 60.0
|
29.0 score on a scale
Interval 22.0 to 54.0
|
|
International Cooperative Ataxia Rating Scale [ICARS] (Total Score)
Change from Baseline (Week 0) to Week 12
|
0.0 score on a scale
Interval -9.0 to 6.0
|
0.5 score on a scale
Interval -4.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Posture and gait disturbances. Posture and gait disturbances score range from 0 to 34 (Higher scores indicate higher levels of impairment).
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
ICARS (Posture and Gait Disturbance Score)
Baseline (Week 0)
|
19.0 score on a scale
Interval 8.0 to 29.0
|
12.5 score on a scale
Interval 7.0 to 31.0
|
|
ICARS (Posture and Gait Disturbance Score)
Week 12
|
18.0 score on a scale
Interval 10.0 to 32.0
|
12.0 score on a scale
Interval 10.0 to 29.0
|
|
ICARS (Posture and Gait Disturbance Score)
Change from Baseline (Week 0) to Week 12
|
1.0 score on a scale
Interval -6.0 to 3.0
|
2.8 score on a scale
Interval -3.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Kinetic Function. Kinetic Function score range from 0 to 52 (Higher scores indicate higher levels of impairment).
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
ICARS (Kinetic Function Score)
Baseline (Week 0)
|
15.0 score on a scale
Interval 11.0 to 19.0
|
11.5 score on a scale
Interval 9.0 to 22.0
|
|
ICARS (Kinetic Function Score)
Week 12
|
13.0 score on a scale
Interval 11.0 to 24.0
|
13.0 score on a scale
Interval 11.0 to 22.0
|
|
ICARS (Kinetic Function Score)
Change from Baseline (Week 0) to Week 12
|
0.0 score on a scale
Interval -6.0 to 5.0
|
0.5 score on a scale
Interval -2.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Speech Disorders. Speech Disorders Score range from 0 to 8 (Higher scores indicate higher levels of impairment).
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
ICARS (Speech Disorders Score)
Baseline (Week 0)
|
2.0 score on a scale
Interval 0.0 to 4.0
|
0.5 score on a scale
Interval 0.0 to 3.0
|
|
ICARS (Speech Disorders Score)
Week 12
|
1.0 score on a scale
Interval 0.0 to 2.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
|
ICARS (Speech Disorders Score)
Change from Baseline (Week 0) to Week 12
|
0.0 score on a scale
Interval -3.0 to 1.0
|
0.0 score on a scale
Interval -1.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Oculomotor Disorders. Oculomotor Disorders score range from 0 to 6 (Higher scores indicate higher levels of impairment).
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
ICARS (Oculomotor Disorders Score)
Baseline (Week 0)
|
1.0 score on a scale
Interval 0.0 to 2.0
|
1.5 score on a scale
Interval 0.0 to 3.0
|
|
ICARS (Oculomotor Disorders Score)
Week 12
|
2.0 score on a scale
Interval 1.0 to 3.0
|
2.0 score on a scale
Interval 1.0 to 2.0
|
|
ICARS (Oculomotor Disorders Score)
Change from Baseline (Week 0) to Week 12
|
0.0 score on a scale
Interval 0.0 to 1.0
|
0.0 score on a scale
Interval -1.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Timed 25-foot Walk Test
Baseline (Week 0)
|
8.50 seconds
Interval 6.0 to 16.0
|
6.75 seconds
Interval 5.0 to 29.5
|
|
Timed 25-foot Walk Test
Week 12
|
9.00 seconds
Interval 7.0 to 15.5
|
6.75 seconds
Interval 5.5 to 29.5
|
|
Timed 25-foot Walk Test
Change from Baseline (Week 0) to Week 12
|
0.50 seconds
Interval -1.0 to 2.0
|
0.00 seconds
Interval -2.5 to 0.5
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Nine Hole Peg Test (Dominant Hand)
Baseline (Week 0)
|
38.50 seconds
Interval 31.5 to 71.5
|
43.50 seconds
Interval 33.5 to 91.5
|
|
Nine Hole Peg Test (Dominant Hand)
Week 12
|
42.00 seconds
Interval 29.5 to 86.0
|
40.75 seconds
Interval 32.0 to 89.5
|
|
Nine Hole Peg Test (Dominant Hand)
Change from Baseline (Week 0) to Week 12
|
1.50 seconds
Interval -2.5 to 15.5
|
-1.50 seconds
Interval -4.0 to 6.5
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Nine Hole Peg Test (Nondominant Hand)
Week 12
|
53.00 seconds
Interval 36.0 to 113.5
|
46.50 seconds
Interval 36.5 to 100.5
|
|
Nine Hole Peg Test (Nondominant Hand)
Baseline (Week 0)
|
47.50 seconds
Interval 39.5 to 113.0
|
48.50 seconds
Interval 34.5 to 117.5
|
|
Nine Hole Peg Test (Nondominant Hand)
Change from Baseline (Week 0) to Week 12
|
0.50 seconds
Interval -11.0 to 7.0
|
1.75 seconds
Interval -17.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Choice Reaction Time Test- Reaction Time
Baseline (Week 0)
|
513.5 millisecond
Interval 392.0 to 1594.0
|
536.0 millisecond
Interval 461.0 to 692.0
|
|
Choice Reaction Time Test- Reaction Time
Week 12
|
491.0 millisecond
Interval 417.0 to 899.0
|
531.0 millisecond
Interval 446.0 to 865.0
|
|
Choice Reaction Time Test- Reaction Time
Change from Baseline (Week 0) to Week 12
|
8.5 millisecond
Interval -1032.0 to 40.0
|
9.0 millisecond
Interval -89.0 to 173.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Choice Reaction Time Test- Movement Time
Baseline (Week 0)
|
561.5 millisecond
Interval 344.0 to 1452.0
|
531.0 millisecond
Interval 390.0 to 986.0
|
|
Choice Reaction Time Test- Movement Time
Week 12
|
555.0 millisecond
Interval 406.0 to 1107.0
|
496.5 millisecond
Interval 396.0 to 1419.0
|
|
Choice Reaction Time Test- Movement Time
Change from Baseline (Week 0) to Week 12
|
4.5 millisecond
Interval -998.0 to 190.0
|
-31.0 millisecond
Interval -124.0 to 433.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Visual Assessment Scale (VAS) of Global Impression - Patient
Baseline (Week 0)
|
60.0 mm
Interval 18.0 to 80.0
|
68.5 mm
Interval 12.0 to 100.0
|
|
Visual Assessment Scale (VAS) of Global Impression - Patient
Week 12
|
67.0 mm
Interval 12.0 to 82.0
|
63.0 mm
Interval 26.0 to 100.0
|
|
Visual Assessment Scale (VAS) of Global Impression - Patient
Change from Baseline (Week 0) to Week 12
|
-2.0 mm
Interval -47.0 to 30.0
|
-2.0 mm
Interval -20.0 to 59.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Visual Assessment Scale (VAS) of Global Impression - Parents
Baseline (Week 0)
|
64.0 mm
Interval 45.0 to 96.0
|
62.0 mm
Interval 16.0 to 87.0
|
|
Visual Assessment Scale (VAS) of Global Impression - Parents
Week 12
|
64.0 mm
Interval 31.0 to 95.0
|
57.0 mm
Interval 11.0 to 72.0
|
|
Visual Assessment Scale (VAS) of Global Impression - Parents
Change from Baseline (Week 0) to Week 12
|
-7.0 mm
Interval -14.0 to 13.0
|
-10.0 mm
Interval -25.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 12Population: 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.
The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.
Outcome measures
| Measure |
EGb 761® 120 mg
n=11 Participants
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=10 Participants
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
|
|---|---|---|
|
Visual Assessment Scale (VAS) of Global Impression - Investigator
Baseline (Week 0)
|
78.0 mm
Interval 67.0 to 90.0
|
76.0 mm
Interval 25.0 to 90.0
|
|
Visual Assessment Scale (VAS) of Global Impression - Investigator
Week 12
|
80.0 mm
Interval 46.0 to 87.0
|
74.0 mm
Interval 46.0 to 86.0
|
|
Visual Assessment Scale (VAS) of Global Impression - Investigator
Change from Baseline (Week 0) to Week 12
|
-2.0 mm
Interval -36.0 to 13.0
|
-1.0 mm
Interval -23.0 to 52.0
|
Adverse Events
EGb 761® 120 mg
Placebo
Serious adverse events
| Measure |
EGb 761® 120 mg
n=11 participants at risk
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=11 participants at risk
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed.
|
|---|---|---|
|
Infections and infestations
Varicella
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Sciatica
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
EGb 761® 120 mg
n=11 participants at risk
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
|
Placebo
n=11 participants at risk
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
18.2%
2/11 • Number of events 2
|
0.00%
0/11
|
|
Infections and infestations
Influenza
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Number of events 3
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Fall
|
9.1%
1/11 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Surgical and medical procedures
Orthopedic procedure
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60