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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at a single centre investigational site in France.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    EGb 761® 120 mg   Placebo
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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 Total of all reporting groups

Baseline Measures
   EGb 761® 120 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   10   21 
Age, Customized 
[Units: Participants]
     
12-15 years   5   4   9 
16-22 years   6   6   12 
Gender 
[Units: Participants]
     
Female   5   5   10 
Male   6   5   11 
Duration since first symptoms 
[Units: Years]
Median (Full Range)
 8.1 
 (3 to 15) 
 7.7 
 (4 to 18) 
 7.8 
 (3 to 18) 
Number of repeats of Guanine Adenine Adenine (GAA) sequence 
[Units: GAA sequence repetitions]
Median (Full Range)
 700 
 (500 to 950) 
 810 
 (100 to 1000) 
 700 
 (100 to 1000) 


  Outcome Measures

1.  Primary:   Creatine Rephosphorylation Rate Post Exercise   [ Time Frame: Baseline (Week 0) to Week 12 ]

2.  Secondary:   Peak Post Exercise Perfusion   [ Time Frame: Baseline (Week 0) to Week 12 ]

3.  Secondary:   Time to Peak Perfusion   [ Time Frame: Baseline (Week 0) to Week 12 ]

4.  Secondary:   Perfusion-time Integral During the First 9 Minutes Post Exercise.   [ Time Frame: Baseline (Week 0) to Week 12 ]

5.  Secondary:   Muscle Reoxygenation Rate Post Exercise.   [ Time Frame: Baseline (Week 0) to Week 12 ]

6.  Secondary:   Muscle Trophicity: Maximum Cross Section of Muscle   [ Time Frame: Baseline (Week 0) to Week 12 ]

7.  Secondary:   Developed Force During the Exercise Bout   [ Time Frame: Baseline (Week 0) to Week 12 ]

8.  Secondary:   Normalised Work Developed During the Exercise   [ Time Frame: Baseline (Week 0) to Week 12 ]

9.  Secondary:   Metabolism Efficacy Index   [ Time Frame: Baseline (Week 0) to Week 12 ]

10.  Secondary:   International Cooperative Ataxia Rating Scale [ICARS] (Total Score)   [ Time Frame: Baseline (Week 0) to Week 12 ]

11.  Secondary:   ICARS (Posture and Gait Disturbance Score)   [ Time Frame: Baseline (Week 0) to Week 12 ]

12.  Secondary:   ICARS (Kinetic Function Score)   [ Time Frame: Baseline (Week 0) to Week 12 ]

13.  Secondary:   ICARS (Speech Disorders Score)   [ Time Frame: Baseline (Week 0) to Week 12 ]

14.  Secondary:   ICARS (Oculomotor Disorders Score)   [ Time Frame: Baseline (Week 0) to Week 12 ]

15.  Secondary:   Timed 25-foot Walk Test   [ Time Frame: Baseline (Week 0) to Week 12 ]

16.  Secondary:   Nine Hole Peg Test (Dominant Hand)   [ Time Frame: Baseline (Week 0) to Week 12 ]

17.  Secondary:   Nine Hole Peg Test (Nondominant Hand)   [ Time Frame: Baseline (Week 0) to Week 12 ]

18.  Secondary:   Choice Reaction Time Test- Reaction Time   [ Time Frame: Baseline (Week 0) to Week 12 ]

19.  Secondary:   Choice Reaction Time Test- Movement Time   [ Time Frame: Baseline (Week 0) to Week 12 ]

20.  Secondary:   Visual Assessment Scale (VAS) of Global Impression - Patient   [ Time Frame: Baseline (Week 0) to Week 12 ]

21.  Secondary:   Visual Assessment Scale (VAS) of Global Impression - Parents   [ Time Frame: Baseline (Week 0) to Week 12 ]

22.  Secondary:   Visual Assessment Scale (VAS) of Global Impression - Investigator   [ Time Frame: Baseline (Week 0) to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: 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