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A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients (MICONOS)

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: NCT00905268
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Friedreich's Ataxia
Interventions Drug: idebenone
Drug: Placebo
Enrollment 232
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Period Title: Overall Study
Started 57 57 59 59
Completed 53 56 59 57
Not Completed 4 1 0 2
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo Total
Hide Arm/Group Description

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Total of all reporting groups
Overall Number of Baseline Participants 57 57 59 59 232
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 57 participants 59 participants 59 participants 232 participants
30.9  (13.7) 31.6  (13.1) 30.9  (13.6) 30.4  (13.3) 30.9  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 59 participants 59 participants 232 participants
Female
23
  40.4%
25
  43.9%
27
  45.8%
32
  54.2%
107
  46.1%
Male
34
  59.6%
32
  56.1%
32
  54.2%
27
  45.8%
125
  53.9%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 59 participants 59 participants 232 participants
Germany 40 41 39 36 156
United Kingdom 4 6 6 5 21
Austria 2 4 2 5 13
Belgium 3 1 5 4 13
France 5 2 4 6 17
Netherlands 3 3 3 3 12
[1]
Measure Description: 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 subjects were analyzed as randomized regardless of protocol deviations
1.Primary Outcome
Title Absolute Change in International Cooperative Ataxia Rating Scale (ICARS) Scores From Baseline Assessment to Week 52
Hide Description 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.
Time Frame Baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description:

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Overall Number of Participants Analyzed 55 55 59 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (5.85) 1.7  (6.64) 1.2  (5.22) 1.1  (6.76)
2.Secondary Outcome
Title Absolute Change in Friedreich's Ataxia Rating Scale (FARS) Scores From Baseline Assessment to Week 52
Hide Description 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.
Time Frame Baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The comparison was carried out in the ITT population, on data imputed using the last observation carried forward (LOCF) method.
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description:

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Overall Number of Participants Analyzed 54 54 59 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (7.19) 1.2  (5.24) 1.4  (5.60) 0.9  (6.77)
3.Secondary Outcome
Title Proportion of Patients Improving (Responding) on ICARS by a Clinically Relevant Margin
Hide Description

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.

Time Frame week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description:

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Overall Number of Participants Analyzed 55 55 59 58
Measure Type: Number
Unit of Measure: percentage of patients
18.2 23.6 23.7 31
4.Secondary Outcome
Title 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
Hide Description (In the statistical analysis sub-population presenting with cardiac involvement as defined by the FRDA cardiomyopathy criteria)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description:

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Overall Number of Participants Analyzed 36 35 33 34
Measure Type: Number
Unit of Measure: percentage of patients
50 51.4 30.3 44.1
5.Secondary Outcome
Title Change in Peak Systolic Strain Rate From Baseline to Week 52
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description:

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Overall Number of Participants Analyzed 36 35 33 34
Mean (Standard Deviation)
Unit of Measure: 1/s
0.007  (0.220) -0.004  (0.265) 0.085  (0.227) 0.024  (0.192)
6.Secondary Outcome
Title Change in Peak Workload From Baseline to Week 52
Hide Description

Assessed 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])).

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description:

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Overall Number of Participants Analyzed 55 55 59 58
Mean (Standard Deviation)
Unit of Measure: Watts
1.15  (16.362) -7.41  (34.499) -6.91  (20.179) -1.54  (16.509)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Hide Arm/Group Description

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.

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.

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.

placebo

Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

All-Cause Mortality
Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/57 (12.28%)      4/57 (7.02%)      8/59 (13.56%)      7/59 (11.86%)    
Cardiac disorders         
hypertrophic cardiomyopathy  0/57 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/59 (1.69%)  1
supraventricular tachycardia  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0 2/59 (3.39%)  2
Atrial fibrillation  1/57 (1.75%)  1 1/57 (1.75%)  1 1/59 (1.69%)  1 1/59 (1.69%)  1
tachycardia  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0 0/59 (0.00%)  0
atrial flutter  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0 0/59 (0.00%)  0
suparventricular extrasystoles  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0 0/59 (0.00%)  0
cardiac failure  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
Endocrine disorders         
diabetes mellitus  0/57 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/59 (1.69%)  1
Gastrointestinal disorders         
Gastritis  0/57 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/59 (1.69%)  1
inguinal hernia  2/57 (3.51%)  2 0/57 (0.00%)  0 0/59 (0.00%)  0 0/59 (0.00%)  0
diarrhea  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
gastrointestinal infection  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
General disorders         
influenza like illness  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
procedural pain  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
Infections and infestations         
Sinusitis  0/57 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/59 (1.69%)  1
gastroenteritis  0/57 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0 1/59 (1.69%)  1
staphylococcal sepsis  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
urinary tract infection  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
Injury, poisoning and procedural complications         
hand fracture  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
spinal fracture  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
Investigations         
blood creatinine abnormal  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
Musculoskeletal and connective tissue disorders         
osteoarthritis  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
abortion spontaneous  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0 0/59 (0.00%)  0
drug exposure during pregnancy  1/57 (1.75%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0 0/59 (0.00%)  0
Psychiatric disorders         
depression  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
suicide attempt  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
Renal and urinary disorders         
renal tubular necrosis  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
bronchitis  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
pneumonia aspiration  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
chest pain  0/57 (0.00%)  0 1/57 (1.75%)  1 0/59 (0.00%)  0 0/59 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A: Idebenone Group B: Idebenone C: Idebenone D: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/57 (96.49%)      52/57 (91.23%)      52/59 (88.14%)      55/59 (93.22%)    
Cardiac disorders         
palpitations  1/57 (1.75%)  1 1/57 (1.75%)  1 3/59 (5.08%)  3 2/59 (3.39%)  2
tachycardia  3/57 (5.26%)  3 0/57 (0.00%)  0 1/59 (1.69%)  1 2/59 (3.39%)  2
Ear and labyrinth disorders         
vertigo  1/57 (1.75%)  1 2/57 (3.51%)  2 0/59 (0.00%)  0 3/59 (5.08%)  3
Gastrointestinal disorders         
diarrhea  10/57 (17.54%)  10 16/57 (28.07%)  16 10/59 (16.95%)  10 8/59 (13.56%)  8
vomiting  9/57 (15.79%)  9 5/57 (8.77%)  5 7/59 (11.86%)  7 2/59 (3.39%)  2
abdominal pain upper  3/57 (5.26%)  3 6/57 (10.53%)  6 6/59 (10.17%)  6 6/59 (10.17%)  6
abdominal pain  4/57 (7.02%)  4 5/57 (8.77%)  5 2/59 (3.39%)  2 7/59 (11.86%)  7
toothache  1/57 (1.75%)  1 6/57 (10.53%)  6 4/59 (6.78%)  4 3/59 (5.08%)  3
dyspepsia  0/57 (0.00%)  0 4/57 (7.02%)  4 1/59 (1.69%)  1 2/59 (3.39%)  2
flatulence  0/57 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1 3/59 (5.08%)  3
General disorders         
fatigue  5/57 (8.77%)  5 2/57 (3.51%)  2 2/59 (3.39%)  2 5/59 (8.47%)  5
edema peripheral  0/57 (0.00%)  0 3/57 (5.26%)  3 3/59 (5.08%)  3 1/59 (1.69%)  1
pyrexia  1/57 (1.75%)  1 3/57 (5.26%)  3 0/59 (0.00%)  0 3/59 (5.08%)  3
influenza like illness  1/57 (1.75%)  1 0/57 (0.00%)  0 3/59 (5.08%)  3 0/59 (0.00%)  0
Infections and infestations         
nasopharyngitis  22/57 (38.60%)  22 25/57 (43.86%)  25 21/59 (35.59%)  21 21/59 (35.59%)  21
influenza  7/57 (12.28%)  7 6/57 (10.53%)  6 4/59 (6.78%)  4 5/59 (8.47%)  5
bronchitis  3/57 (5.26%)  3 3/57 (5.26%)  3 4/59 (6.78%)  4 1/59 (1.69%)  1
sinusitis  2/57 (3.51%)  2 1/57 (1.75%)  1 3/59 (5.08%)  3 4/59 (6.78%)  4
gastroenteritis  1/57 (1.75%)  1 2/57 (3.51%)  2 3/59 (5.08%)  3 2/59 (3.39%)  2
upper respiratory tract infection  2/57 (3.51%)  2 1/57 (1.75%)  1 3/59 (5.08%)  3 2/59 (3.39%)  2
cystitis  1/57 (1.75%)  1 4/57 (7.02%)  4 1/59 (1.69%)  1 1/59 (1.69%)  1
rhinitis  2/57 (3.51%)  2 0/57 (0.00%)  0 1/59 (1.69%)  1 3/59 (5.08%)  3
Injury, poisoning and procedural complications         
fall  4/57 (7.02%)  4 7/57 (12.28%)  7 2/59 (3.39%)  2 7/59 (11.86%)  7
Musculoskeletal and connective tissue disorders         
pain in extremity  4/57 (7.02%)  4 7/57 (12.28%)  7 5/59 (8.47%)  5 5/59 (8.47%)  5
muscle spasms  1/57 (1.75%)  1 2/57 (3.51%)  2 2/59 (3.39%)  2 5/59 (8.47%)  5
Nervous system disorders         
headache  16/57 (28.07%)  16 20/57 (35.09%)  20 15/59 (25.42%)  15 23/59 (38.98%)  23
Respiratory, thoracic and mediastinal disorders         
cough  11/57 (19.30%)  11 2/57 (3.51%)  2 6/59 (10.17%)  6 6/59 (10.17%)  6
oropharyngeal pain  5/57 (8.77%)  5 6/57 (10.53%)  6 6/59 (10.17%)  6 7/59 (11.86%)  7
Skin and subcutaneous tissue disorders         
rash  3/57 (5.26%)  3 1/57 (1.75%)  1 1/59 (1.69%)  1 3/59 (5.08%)  3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Prof. Nicholas William Wood
Organization: The National Hospital, University College London
Phone: 020 7837 3611
Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00905268     History of Changes
Other Study ID Numbers: SNT-III-001
First Submitted: May 19, 2009
First Posted: May 20, 2009
Results First Submitted: October 20, 2015
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016