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(+) Epicatechin to Treat Friedreich's Ataxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02660112
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
Cardero Therapeutics, Inc.
Information provided by (Responsible Party):
Ralitza Gavrilova, Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Friedreich's Ataxia
Intervention Drug: (+)-Epicatechin
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title (+)-Epicatechin
Hide Arm/Group Description

Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks

(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title (+)-Epicatechin
Hide Arm/Group Description

Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks

(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants
14.5
(10 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Change From Baseline in Friedreich Ataxia Rating Scale (FARS) Composite Score
Hide Description

The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, an activities of daily living subscale and a neurological subscale. This scale also includes the 8m walk at maximum speed (8MW), the 9-hole peg test (9HPT), PATA rate (assesses speech speed by repetitions of pronouncing "PaTa" ) and low-contrast letter acuity.

FARS is made up of a measure of ataxia, an activities of daily living subscale and a neurological subscale. This scale also includes the 8m walk at maximum speed (8MW), the 9-hole peg test (9HPT), PATA rate and low-contrast letter acuity. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.

Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One subject did not complete week 24 questionnaire
Arm/Group Title (+)-Epicatechin
Hide Arm/Group Description:

Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks

(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
55.0  (18.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection (+)-Epicatechin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Change in Ventricular Hypertrophy as Shown on Cardiac MRI
Hide Description Left ventricular mass and left ventricular (LV) mass indexed to body surface area estimated by Left Ventricle (LV)cavity dimension and wall thickness at end-diastole. Normal values of LV mass indexed to body surface area are found to be 49-115 gL/m2 in men and 43-95 g/m2 in women.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title (+)-Epicatechin
Hide Arm/Group Description:

Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks

(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mL/m2
55.9  (9.49)
Time Frame Adverse Events were collected over a 24 week time period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title (+)-Epicatechin
Hide Arm/Group Description

Total daily dose 75mg (+)-Epicatechin; 25mg cap three times per day by mouth for 24 weeks

(+)-Epicatechin: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)

All-Cause Mortality
(+)-Epicatechin
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Serious Adverse Events
(+)-Epicatechin
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
(+)-Epicatechin
Affected / at Risk (%)
Total   3/10 (30.00%) 
Nervous system disorders   
Transient worsening of migraine   3/10 (30.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ralitza H. Gavrilova, M.D.
Organization: Mayo Clinic
Phone: 507-293-1283
EMail: Gavrilova.Ralitza@mayo.edu
Layout table for additonal information
Responsible Party: Ralitza Gavrilova, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02660112    
Other Study ID Numbers: 15-006845
First Submitted: January 18, 2016
First Posted: January 21, 2016
Results First Submitted: November 18, 2019
Results First Posted: December 5, 2019
Last Update Posted: December 5, 2019