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Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia

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ClinicalTrials.gov Identifier: NCT00824512
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Friedreich Ataxia
Interventions Drug: EGb 761 120 mg
Drug: Placebo
Enrollment 22

Recruitment Details Patients were recruited at a single centre investigational site in France.
Pre-assignment Details 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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Period Title: Overall Study
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title EGb 761® 120 mg Placebo Total
Hide Arm/Group Description EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks

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 of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
12-15 years 5 4 9
16-22 years 6 6 12
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
5
  45.5%
5
  50.0%
10
  47.6%
Male
6
  54.5%
5
  50.0%
11
  52.4%
Duration since first symptoms  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
8.1
(3 to 15)
7.7
(4 to 18)
7.8
(3 to 18)
Number of repeats of Guanine Adenine Adenine (GAA) sequence  
Median (Full Range)
Unit of measure:  GAA sequence repetitions
Number Analyzed 11 participants 10 participants 21 participants
700
(500 to 950)
810
(100 to 1000)
700
(100 to 1000)
1.Primary Outcome
Title Creatine Rephosphorylation Rate Post Exercise
Hide Description Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: pH per second
Baseline (Week 0)
0.024
(0.013 to 0.037)
0.029
(0.018 to 0.040)
Week 12
0.022
(0.015 to 0.043)
0.029
(0.014 to 0.035)
Change from Baseline (Week 0) to Week 12
0.001
(-0.009 to 0.009)
0.000
(-0.013 to 0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EGb 761® 120 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9133
Comments No multiplicity adjustment performed for this study and all statistical tests are two-sided at the 5% significance level.
Method Non parametric ANCOVA on the rank test
Comments The baseline value was used as a covariate.
2.Secondary Outcome
Title Peak Post Exercise Perfusion
Hide Description Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: ml/mn/100 g of tissue
Baseline (Week 0)
54.30
(33.9 to 91.0)
51.80
(10.8 to 81.4)
Week 12
58.80
(37.6 to 88.8)
46.60
(30.7 to 63.1)
Change from Baseline (Week 0) to Week 12
3.60
(-29.5 to 31.2)
-1.55
(-20.9 to 23.2)
3.Secondary Outcome
Title Time to Peak Perfusion
Hide Description [Not Specified]
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: seconds
Baseline (Week 0)
38.30
(0.8 to 269.3)
58.55
(5.3 to 317.3)
Week 12
39.80
(0.8 to 119.3)
76.55
(0.8 to 384.8)
Change from Baseline (Week 0) to Week 12
8.50
(-267.0 to 94.5)
14.25
(-232.5 to 274.5)
4.Secondary Outcome
Title Perfusion-time Integral During the First 9 Minutes Post Exercise.
Hide Description The integral of 'peak perfusion' over a period of 9 minutes post exercise.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: mL/100 g of tissue
Baseline (Week 0)
166.90
(83.6 to 353.0)
157.20
(11.8 to 373.0)
Week 12
191.60
(86.1 to 417.3)
185.70
(22.0 to 396.7)
Change from Baseline (Week 0) to Week 12
-5.20
(-138.2 to 237.4)
0.05
(-156.7 to 212.9)
5.Secondary Outcome
Title Muscle Reoxygenation Rate Post Exercise.
Hide Description Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: per second
Baseline (Week 0)
0.0870
(0.035 to 0.156)
0.0540
(0.024 to 0.123)
Week 12
0.0580
(0.030 to 0.114)
0.0620
(0.021 to 0.087)
Change from Baseline (Week 0) to Week 12
-0.0350
(-0.124 to 0.039)
-0.0035
(-0.058 to 0.049)
6.Secondary Outcome
Title Muscle Trophicity: Maximum Cross Section of Muscle
Hide Description Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm^2)
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: cm^2
Baseline (Week 0)
28.10
(16.6 to 33.1)
28.95
(23.4 to 42.4)
Week 12
26.8
(16.7 to 33.2)
29.85
(24.0 to 42.9)
Change from Baseline (Week 0) to Week 12
0.10
(-1.3 to 0.7)
0.55
(-2.1 to 2.1)
7.Secondary Outcome
Title Developed Force During the Exercise Bout
Hide Description Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: Joules
Baseline (Week 0)
305.30
(177.0 to 822.9)
358.10
(207.2 to 1172.8)
Week 12
277.50
(136.90 to 750.9)
354.35
(200.9 to 1002.1)
Change from Baseline (Week 0) to Week 12
-32.40
(-146.9 to 56.6)
19.20
(-191.8 to 109.8)
8.Secondary Outcome
Title Normalised Work Developed During the Exercise
Hide Description

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.

Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: Joules/cm^2
Baseline (Week 0)
12.07
(6.3 to 26.0)
12.00
(8.6 to 30.5)
Week 12
9.23
(7.6 to 24.0)
11.53
(6.1 to 25.7)
Change from Baseline (Week 0) to Week 12
-1.03
(-6.3 to 2.6)
0.47
(-4.8 to 4.6)
9.Secondary Outcome
Title Metabolism Efficacy Index
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: per second
Baseline (Week 0)
0.0180
(-0.042 to 0.038)
0.0150
(0.010 to 0.029)
Week 12
0.0130
(-0.021 to 0.042)
0.0145
(0.007 to 0.028)
Change from Baseline (Week 0) to Week 12
0.0010
(-0.021 to 0.021)
-0.0010
(-0.007 to 0.001)
10.Secondary Outcome
Title International Cooperative Ataxia Rating Scale [ICARS] (Total Score)
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: score on a scale
Baseline (Week 0)
35
(21 to 54)
26.5
(20 to 58)
Week 12
33.0
(26 to 60)
29.0
(22 to 54)
Change from Baseline (Week 0) to Week 12
0.0
(-9 to 6)
0.5
(-4 to 11)
11.Secondary Outcome
Title ICARS (Posture and Gait Disturbance Score)
Hide Description 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).
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: score on a scale
Baseline (Week 0)
19.0
(8 to 29)
12.5
(7 to 31)
Week 12
18.0
(10 to 32)
12.0
(10 to 29)
Change from Baseline (Week 0) to Week 12
1.0
(-6 to 3)
2.8
(-3 to 4)
12.Secondary Outcome
Title ICARS (Kinetic Function Score)
Hide Description 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).
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: score on a scale
Baseline (Week 0)
15.0
(11 to 19)
11.5
(9 to 22)
Week 12
13.0
(11 to 24)
13.0
(11 to 22)
Change from Baseline (Week 0) to Week 12
0.0
(-6 to 5)
0.5
(-2 to 5)
13.Secondary Outcome
Title ICARS (Speech Disorders Score)
Hide Description 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).
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: score on a scale
Baseline (Week 0)
2.0
(0 to 4)
0.5
(0 to 3)
Week 12
1.0
(0 to 2)
1.0
(0 to 2)
Change from Baseline (Week 0) to Week 12
0.0
(-3 to 1)
0.0
(-1 to 2)
14.Secondary Outcome
Title ICARS (Oculomotor Disorders Score)
Hide Description 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).
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: score on a scale
Baseline (Week 0)
1.0
(0 to 2)
1.5
(0 to 3)
Week 12
2.0
(1 to 3)
2.0
(1 to 2)
Change from Baseline (Week 0) to Week 12
0.0
(0 to 1)
0.0
(-1 to 2)
15.Secondary Outcome
Title Timed 25-foot Walk Test
Hide Description [Not Specified]
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: seconds
Baseline (Week 0)
8.50
(6.0 to 16.0)
6.75
(5.0 to 29.5)
Week 12
9.00
(7.0 to 15.5)
6.75
(5.5 to 29.5)
Change from Baseline (Week 0) to Week 12
0.50
(-1.0 to 2.0)
0.00
(-2.5 to 0.5)
16.Secondary Outcome
Title Nine Hole Peg Test (Dominant Hand)
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: seconds
Baseline (Week 0)
38.50
(31.5 to 71.5)
43.50
(33.5 to 91.5)
Week 12
42.00
(29.5 to 86.0)
40.75
(32.0 to 89.5)
Change from Baseline (Week 0) to Week 12
1.50
(-2.5 to 15.5)
-1.50
(-4.0 to 6.5)
17.Secondary Outcome
Title Nine Hole Peg Test (Nondominant Hand)
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: seconds
Baseline (Week 0)
47.50
(39.5 to 113.0)
48.50
(34.5 to 117.5)
Week 12
53.00
(36.0 to 113.5)
46.50
(36.5 to 100.5)
Change from Baseline (Week 0) to Week 12
0.50
(-11.0 to 7.0)
1.75
(-17.0 to 7.0)
18.Secondary Outcome
Title Choice Reaction Time Test- Reaction Time
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: millisecond
Baseline (Week 0)
513.5
(392 to 1594)
536.0
(461 to 692)
Week 12
491.0
(417 to 899)
531.0
(446 to 865)
Change from Baseline (Week 0) to Week 12
8.5
(-1032 to 40)
9.0
(-89 to 173)
19.Secondary Outcome
Title Choice Reaction Time Test- Movement Time
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: millisecond
Baseline (Week 0)
561.5
(344 to 1452)
531.0
(390 to 986)
Week 12
555.0
(406 to 1107)
496.5
(396 to 1419)
Change from Baseline (Week 0) to Week 12
4.5
(-998 to 190)
-31.0
(-124 to 433)
20.Secondary Outcome
Title Visual Assessment Scale (VAS) of Global Impression - Patient
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: mm
Baseline (Week 0)
60.0
(18 to 80)
68.5
(12 to 100)
Week 12
67.0
(12 to 82)
63.0
(26 to 100)
Change from Baseline (Week 0) to Week 12
-2.0
(-47 to 30)
-2.0
(-20 to 59)
21.Secondary Outcome
Title Visual Assessment Scale (VAS) of Global Impression - Parents
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: mm
Baseline (Week 0)
64.0
(45 to 96)
62.0
(16 to 87)
Week 12
64.0
(31 to 95)
57.0
(11 to 72)
Change from Baseline (Week 0) to Week 12
-7.0
(-14 to 13)
-10.0
(-25 to 14)
22.Secondary Outcome
Title Visual Assessment Scale (VAS) of Global Impression - Investigator
Hide Description 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.
Time Frame Baseline (Week 0) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description:
EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
Overall Number of Participants Analyzed 11 10
Median (Full Range)
Unit of Measure: mm
Baseline (Week 0)
78.0
(67 to 90)
76.0
(25 to 90)
Week 12
80.0
(46 to 87)
74.0
(46 to 86)
Change from Baseline (Week 0) to Week 12
-2.0
(-36 to 13)
-1.0
(-23 to 52)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EGb 761® 120 mg Placebo
Hide Arm/Group Description EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks

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.

All-Cause Mortality
EGb 761® 120 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EGb 761® 120 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      1/11 (9.09%)    
Infections and infestations     
Varicella  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Nervous system disorders     
Sciatica  1  0/11 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EGb 761® 120 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/11 (72.73%)      7/11 (63.64%)    
Gastrointestinal disorders     
Abdominal pain  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Abdominal pain upper  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Toothache  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Diarrhoea  1  0/11 (0.00%)  0 1/11 (9.09%)  1
General disorders     
Pyrexia  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Pain  1  0/11 (0.00%)  0 1/11 (9.09%)  1
Fall  1  1/11 (9.09%)  1 2/11 (18.18%)  2
Infections and infestations     
Nasopharyngitis  1  2/11 (18.18%)  2 0/11 (0.00%)  0
Influenza  1  1/11 (9.09%)  1 1/11 (9.09%)  1
Gastroenteritis viral  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Gastroenteritis  1  0/11 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/11 (9.09%)  1 1/11 (9.09%)  1
Pain in extremity  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Scoliosis  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Nervous system disorders     
Headache  1  3/11 (27.27%)  3 2/11 (18.18%)  2
Tremor  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Oropharyngeal pain  1  1/11 (9.09%)  1 0/11 (0.00%)  0
Surgical and medical procedures     
Orthopedic procedure  1  0/11 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director, Primary Care
Organization: Ipsen
Phone: clinical.trials@ipsen.com
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00824512     History of Changes
Other Study ID Numbers: 2-39-00240-133
2007-005371-34 ( EudraCT Number )
First Submitted: January 15, 2009
First Posted: January 16, 2009
Results First Submitted: October 30, 2012
Results First Posted: May 21, 2013
Last Update Posted: May 21, 2013