Trial Outcomes & Findings for A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients (NCT NCT00905268)
NCT ID: NCT00905268
Last Updated: 2016-06-27
Results Overview
The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
232 participants
Primary outcome timeframe
Baseline and week 52
Results posted on
2016-06-27
Participant Flow
Participant milestones
| Measure |
Group A: Idebenone
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
59
|
59
|
|
Overall Study
COMPLETED
|
53
|
56
|
59
|
57
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients
Baseline characteristics by cohort
| Measure |
Group A: Idebenone
n=57 Participants
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=57 Participants
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=59 Participants
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=59 Participants
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
Germany
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
39 participants
n=5 Participants
|
36 participants
n=4 Participants
|
156 participants
n=21 Participants
|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
31.6 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
30.9 years
STANDARD_DEVIATION 13.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
12 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 52Population: The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.
The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.
Outcome measures
| Measure |
Group A: Idebenone
n=55 Participants
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=55 Participants
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=59 Participants
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=58 Participants
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Absolute Change in International Cooperative Ataxia Rating Scale (ICARS) Scores From Baseline Assessment to Week 52
|
1.6 units on a scale
Standard Deviation 5.85
|
1.7 units on a scale
Standard Deviation 6.64
|
1.2 units on a scale
Standard Deviation 5.22
|
1.1 units on a scale
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: Baseline and week 52Population: The comparison was carried out in the ITT population, on data imputed using the last observation carried forward (LOCF) method.
The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, and activities of daily living subscale and a neurological subscale. 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.
Outcome measures
| Measure |
Group A: Idebenone
n=54 Participants
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=54 Participants
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=59 Participants
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=58 Participants
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Absolute Change in Friedreich's Ataxia Rating Scale (FARS) Scores From Baseline Assessment to Week 52
|
0.9 units on a scale
Standard Deviation 7.19
|
1.2 units on a scale
Standard Deviation 5.24
|
1.4 units on a scale
Standard Deviation 5.60
|
0.9 units on a scale
Standard Deviation 6.77
|
SECONDARY outcome
Timeframe: week 52Population: The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.
The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome. ICARS Responder Analysis at Week 52: Percentage of subjects Improving by 2.5 Points or More.
Outcome measures
| Measure |
Group A: Idebenone
n=55 Participants
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=55 Participants
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=59 Participants
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=58 Participants
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Proportion of Patients Improving (Responding) on ICARS by a Clinically Relevant Margin
|
18.2 percentage of patients
|
23.6 percentage of patients
|
23.7 percentage of patients
|
31 percentage of patients
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Subgroup of subjects with cardiac involvement as defined by Friedreich's ataxia cardiomyopathy (FRDA-CM)
(In the statistical analysis sub-population presenting with cardiac involvement as defined by the FRDA cardiomyopathy criteria)
Outcome measures
| Measure |
Group A: Idebenone
n=36 Participants
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=35 Participants
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=33 Participants
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=34 Participants
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Proportion of Patients Improving on Left Ventricular Peak Systolic Strain Rate or Showing a Reduction in Left Ventricular Mass Index (LVMI) With no Worsening in Strain Rate
|
50 percentage of patients
|
51.4 percentage of patients
|
30.3 percentage of patients
|
44.1 percentage of patients
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Subgroup of subjects with cardiac involvement as defined by Friedreich's ataxia cardiomyopathy (FRDA-CM)
Mean Change of Peak systolic longitudinal strain rate (PSLSR) from Baseline to Week 52 in subjects with cardiac involvement (FRDA-CM criteria), where positive value in PSLSR is a deterioration and negative value an improvement.
Outcome measures
| Measure |
Group A: Idebenone
n=36 Participants
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=35 Participants
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=33 Participants
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=34 Participants
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Change in Peak Systolic Strain Rate From Baseline to Week 52
|
0.007 1/s
Standard Deviation 0.220
|
-0.004 1/s
Standard Deviation 0.265
|
0.085 1/s
Standard Deviation 0.227
|
0.024 1/s
Standard Deviation 0.192
|
SECONDARY outcome
Timeframe: 1 yearAssessed by a modified exercise test, in a subset of patients able to undertake this. Wpeak has been calculated from the following formula: Workload last fully completed stage + (seconds completed in last stage / 60 \* (4 \[if arm ergonometry\] or 10 \[if leg ergonometry\])).
Outcome measures
| Measure |
Group A: Idebenone
n=55 Participants
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=55 Participants
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=59 Participants
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=58 Participants
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Change in Peak Workload From Baseline to Week 52
|
1.15 Watts
Standard Deviation 16.362
|
-7.41 Watts
Standard Deviation 34.499
|
-6.91 Watts
Standard Deviation 20.179
|
-1.54 Watts
Standard Deviation 16.509
|
Adverse Events
Group A: Idebenone
Serious events: 7 serious events
Other events: 55 other events
Deaths: 0 deaths
Group B: Idebenone
Serious events: 4 serious events
Other events: 52 other events
Deaths: 0 deaths
C: Idebenone
Serious events: 8 serious events
Other events: 52 other events
Deaths: 0 deaths
D: Placebo
Serious events: 7 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Idebenone
n=57 participants at risk
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=57 participants at risk
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=59 participants at risk
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=59 participants at risk
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
|
Endocrine disorders
diabetes mellitus
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
|
Cardiac disorders
hypertrophic cardiomyopathy
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
|
Cardiac disorders
supraventricular tachycardia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/59
|
3.4%
2/59 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/57 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
abortion spontaneous
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/59
|
0.00%
0/59
|
|
Gastrointestinal disorders
inguinal hernia
|
3.5%
2/57 • Number of events 2
|
0.00%
0/57
|
0.00%
0/59
|
0.00%
0/59
|
|
Pregnancy, puerperium and perinatal conditions
drug exposure during pregnancy
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/59
|
0.00%
0/59
|
|
Cardiac disorders
tachycardia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/59
|
0.00%
0/59
|
|
Cardiac disorders
atrial flutter
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/59
|
0.00%
0/59
|
|
Cardiac disorders
suparventricular extrasystoles
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
0.00%
0/59
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
hand fracture
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Cardiac disorders
cardiac failure
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Gastrointestinal disorders
gastrointestinal infection
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Infections and infestations
staphylococcal sepsis
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia aspiration
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
0.00%
0/57
|
1.8%
1/57 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
spinal fracture
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
Psychiatric disorders
depression
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
Psychiatric disorders
suicide attempt
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
General disorders
influenza like illness
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
General disorders
procedural pain
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
Renal and urinary disorders
renal tubular necrosis
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
|
Investigations
blood creatinine abnormal
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
Other adverse events
| Measure |
Group A: Idebenone
n=57 participants at risk
Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
Group B: Idebenone
n=57 participants at risk
Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
C: Idebenone
n=59 participants at risk
Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day
idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
D: Placebo
n=59 participants at risk
placebo
Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.
|
|---|---|---|---|---|
|
Cardiac disorders
palpitations
|
1.8%
1/57 • Number of events 1
|
1.8%
1/57 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
3.4%
2/59 • Number of events 2
|
|
Cardiac disorders
tachycardia
|
5.3%
3/57 • Number of events 3
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
|
Ear and labyrinth disorders
vertigo
|
1.8%
1/57 • Number of events 1
|
3.5%
2/57 • Number of events 2
|
0.00%
0/59
|
5.1%
3/59 • Number of events 3
|
|
Gastrointestinal disorders
diarrhea
|
17.5%
10/57 • Number of events 10
|
28.1%
16/57 • Number of events 16
|
16.9%
10/59 • Number of events 10
|
13.6%
8/59 • Number of events 8
|
|
Gastrointestinal disorders
vomiting
|
15.8%
9/57 • Number of events 9
|
8.8%
5/57 • Number of events 5
|
11.9%
7/59 • Number of events 7
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
abdominal pain upper
|
5.3%
3/57 • Number of events 3
|
10.5%
6/57 • Number of events 6
|
10.2%
6/59 • Number of events 6
|
10.2%
6/59 • Number of events 6
|
|
Gastrointestinal disorders
abdominal pain
|
7.0%
4/57 • Number of events 4
|
8.8%
5/57 • Number of events 5
|
3.4%
2/59 • Number of events 2
|
11.9%
7/59 • Number of events 7
|
|
Gastrointestinal disorders
toothache
|
1.8%
1/57 • Number of events 1
|
10.5%
6/57 • Number of events 6
|
6.8%
4/59 • Number of events 4
|
5.1%
3/59 • Number of events 3
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/57
|
7.0%
4/57 • Number of events 4
|
1.7%
1/59 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/57
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
General disorders
fatigue
|
8.8%
5/57 • Number of events 5
|
3.5%
2/57 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
8.5%
5/59 • Number of events 5
|
|
General disorders
edema peripheral
|
0.00%
0/57
|
5.3%
3/57 • Number of events 3
|
5.1%
3/59 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
|
General disorders
pyrexia
|
1.8%
1/57 • Number of events 1
|
5.3%
3/57 • Number of events 3
|
0.00%
0/59
|
5.1%
3/59 • Number of events 3
|
|
General disorders
influenza like illness
|
1.8%
1/57 • Number of events 1
|
0.00%
0/57
|
5.1%
3/59 • Number of events 3
|
0.00%
0/59
|
|
Infections and infestations
nasopharyngitis
|
38.6%
22/57 • Number of events 22
|
43.9%
25/57 • Number of events 25
|
35.6%
21/59 • Number of events 21
|
35.6%
21/59 • Number of events 21
|
|
Infections and infestations
influenza
|
12.3%
7/57 • Number of events 7
|
10.5%
6/57 • Number of events 6
|
6.8%
4/59 • Number of events 4
|
8.5%
5/59 • Number of events 5
|
|
Infections and infestations
bronchitis
|
5.3%
3/57 • Number of events 3
|
5.3%
3/57 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
sinusitis
|
3.5%
2/57 • Number of events 2
|
1.8%
1/57 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
|
Infections and infestations
gastroenteritis
|
1.8%
1/57 • Number of events 1
|
3.5%
2/57 • Number of events 2
|
5.1%
3/59 • Number of events 3
|
3.4%
2/59 • Number of events 2
|
|
Infections and infestations
upper respiratory tract infection
|
3.5%
2/57 • Number of events 2
|
1.8%
1/57 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
3.4%
2/59 • Number of events 2
|
|
Infections and infestations
cystitis
|
1.8%
1/57 • Number of events 1
|
7.0%
4/57 • Number of events 4
|
1.7%
1/59 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
rhinitis
|
3.5%
2/57 • Number of events 2
|
0.00%
0/57
|
1.7%
1/59 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
Injury, poisoning and procedural complications
fall
|
7.0%
4/57 • Number of events 4
|
12.3%
7/57 • Number of events 7
|
3.4%
2/59 • Number of events 2
|
11.9%
7/59 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
7.0%
4/57 • Number of events 4
|
12.3%
7/57 • Number of events 7
|
8.5%
5/59 • Number of events 5
|
8.5%
5/59 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
1.8%
1/57 • Number of events 1
|
3.5%
2/57 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
8.5%
5/59 • Number of events 5
|
|
Nervous system disorders
headache
|
28.1%
16/57 • Number of events 16
|
35.1%
20/57 • Number of events 20
|
25.4%
15/59 • Number of events 15
|
39.0%
23/59 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
19.3%
11/57 • Number of events 11
|
3.5%
2/57 • Number of events 2
|
10.2%
6/59 • Number of events 6
|
10.2%
6/59 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
8.8%
5/57 • Number of events 5
|
10.5%
6/57 • Number of events 6
|
10.2%
6/59 • Number of events 6
|
11.9%
7/59 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
rash
|
5.3%
3/57 • Number of events 3
|
1.8%
1/57 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
Additional Information
Prof. Nicholas William Wood
The National Hospital, University College London
Phone: 020 7837 3611
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place