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Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS (MITOTARGET)

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: NCT00868166
Recruitment Status : Completed
First Posted : March 24, 2009
Results First Posted : February 15, 2019
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Amyotrophic Lateral Sclerosis
Interventions Drug: Olesoxime
Drug: Placebo Comparator
Drug: Riluzole
Enrollment 512
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Period Title: Overall Study
Started 259 253
Completed 147 139
Not Completed 112 114
Reason Not Completed
Death             58             65
Withdrawal by Subject             33             25
Protocol Violation             1             0
Lost to Follow-up             1             3
Adverse Event             9             10
Lack of efficacy, logistics, unwell             9             10
Non-compliance with IMP             1             1
Arm/Group Title Olesoxime Placebo Comparator Total
Hide Arm/Group Description

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid Total of all reporting groups
Overall Number of Baseline Participants 259 253 512
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants irrespective of study medication administration and eligibility status.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 259 participants 253 participants 512 participants
57.3  (11.2) 55.7  (11.2) 56.5  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 259 participants 253 participants 512 participants
Female
92
  35.5%
89
  35.2%
181
  35.4%
Male
167
  64.5%
164
  64.8%
331
  64.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 259 participants 253 participants 512 participants
France
113
  43.6%
108
  42.7%
221
  43.2%
Spain
33
  12.7%
34
  13.4%
67
  13.1%
Belgium
13
   5.0%
12
   4.7%
25
   4.9%
Germany
73
  28.2%
74
  29.2%
147
  28.7%
United Kingdom
27
  10.4%
25
   9.9%
52
  10.2%
1.Primary Outcome
Title Overall Survival Rate at 18 Months
Hide Description Overall survival was defined from the date of randomization until the date of death (event) or last known alive date (censored). If the death date was after 18 months, the participant was censored at 18 months (548 days). Participants still alive at or after 18 months were censored at 18 months/ 548 days. All data over the 18-month follow-up period after randomization, and participant survival status at the 18-month follow-up visit for participants who withdrew prematurely from the study for reasons other than death were included.
Time Frame From the date of randomization until the date of death or last follow-up censored at 18 months (548 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of partcipants
67.5
(61.0 to 73.1)
69.4
(63.0 to 74.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olesoxime, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Stratified Log-Rank Test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Failure Over 18 Months
Hide Description Time to failure was defined as the time from randomization to the time of the first event to consider (Tracheostomy, invasive ventilation [IV] or non invasive ventilation [NIV])
Time Frame From randomization to the time of the first event to consider at 18 months (548 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.1
(60.5 to 72.7)
65.5
(59.1 to 71.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olesoxime, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Stratified Log-Rank Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olesoxime, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Non-stratified Log-Rank Test
Comments [Not Specified]
3.Secondary Outcome
Title Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Hide Description The ALSFRS-R is an ordinal rating scale (0 through 4) used to determine the ALS participant's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).
Time Frame Inclusion, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Inclusion Number Analyzed 258 participants 251 participants
39.1  (4.78) 38.2  (5.25)
Month 1 Number Analyzed 258 participants 252 participants
38.2  (5.46) 37.2  (5.59)
Month 2 Number Analyzed 247 participants 247 participants
37.6  (5.64) 36.7  (6.02)
Month 3 Number Analyzed 251 participants 242 participants
36.4  (6.29) 35.3  (6.62)
Month 6 Number Analyzed 230 participants 225 participants
34.3  (7.11) 33.1  (7.62)
Month 9 Number Analyzed 205 participants 201 participants
32.7  (7.72) 30.4  (8.23)
Month 12 Number Analyzed 182 participants 175 participants
30.5  (8.34) 28.8  (8.47)
Month 15 Number Analyzed 163 participants 147 participants
28.6  (8.56) 27.6  (8.92)
Month 18 Number Analyzed 148 participants 136 participants
27.0  (9.38) 26.3  (9.13)
4.Secondary Outcome
Title Percentage of Participants With a Global ALS FRS-R Score of <30 or Death
Hide Description Percentage of participants with a global ALS FRS-R score of < 30 or death was estimated using the Kaplan-Meier method in the ITT, with a two-tailed log-rank, both stratified by site of onset (bulbar or spinal) and non-stratified. The ALSFRS-R is an ordinal rating scale (0 through 4) used to determine the ALS participant's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).
Time Frame Month 18 (548 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.2
(22.5 to 34.1)
24.9
(19.2 to 30.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olesoxime, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Stratified Log-Rank Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olesoxime, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Non-stratified Log-Rank Test
Comments [Not Specified]
5.Secondary Outcome
Title Slow Vital Capacity (SVC) Percent Predicted
Hide Description SVC as a percent of the predicted value was evaluated and reported.
Time Frame Baseline, Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated at specified time points.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Mean (Standard Deviation)
Unit of Measure: percentage (%)
Baseline Number Analyzed 259 participants 253 participants
93.1  (14.6) 93.1  (15.4)
Month 1 Number Analyzed 257 participants 251 participants
89.7  (17.8) 89.7  (17.6)
Month 3 Number Analyzed 249 participants 238 participants
84.8  (20.4) 85.7  (19.7)
Month 6 Number Analyzed 226 participants 219 participants
80.7  (22.9) 80.5  (22.5)
Month 9 Number Analyzed 195 participants 190 participants
77.9  (24.3) 75.5  (24.7)
Month 12 Number Analyzed 170 participants 160 participants
74.5  (25.4) 71.3  (29.0)
Month 15 Number Analyzed 150 participants 150 participants
70.5  (28.8) 71.4  (27.1)
Month 18 Number Analyzed 131 participants 118 participants
69.0  (27.6) 67.1  (25.5)
6.Secondary Outcome
Title Percentage of Participants With SVC Percent Predicted <70% or Had Died Over 18 Months
Hide Description [Not Specified]
Time Frame Month 18 (548 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for specified analysis.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.9
(23.0 to 35.1)
31.9
(25.6 to 38.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olesoxime, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Stratified Log-Rank Test
Comments [Not Specified]
7.Secondary Outcome
Title Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups
Hide Description MMT score involved the examination of 30 items. These 30 items are scored from 0 (no trace of contraction) to 5 (normal power at first try). The global score is the sum of the item scores and can range from 0 to 150. Higher score indicates some power.
Time Frame Inclusion, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Inclusion Number Analyzed 257 participants 250 participants
128  (18.0) 126  (18.8)
Month 3 Number Analyzed 249 participants 239 participants
121  (22.8) 120  (22.0)
Month 6 Number Analyzed 226 participants 221 participants
117  (24.4) 114  (24.6)
Month 9 Number Analyzed 200 participants 196 participants
112  (27.1) 109  (27.1)
Month 12 Number Analyzed 177 participants 168 participants
106  (29.7) 103  (29.6)
Month 15 Number Analyzed 159 participants 137 participants
101  (32.0) 99.2  (31.2)
Month 18 Number Analyzed 147 participants 132 participants
95.2  (33.7) 91.8  (34.7)
8.Secondary Outcome
Title The Single-Item Mc Gill Quality of Life Scale
Hide Description The single-item McGill quality of life scale evaluated the following question "Considering all parts of my life - physical, emotional, social, spiritual, and financial - over the past two (2) days, the quality of my life has been…"as a score of 1 to 10 on a visual analog scale where 0 is very bad and 10 is excellent.
Time Frame Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants irrespective of study medication administration and eligibility status. Number analyzed indicates number of participants who were evaluated for the specified time points.
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description:

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
Overall Number of Participants Analyzed 259 253
Mean (Standard Deviation)
Unit of Measure: score on a scale
Inclusion Number Analyzed 257 participants 249 participants
6.51  (1.65) 6.47  (1.65)
Month 1 Number Analyzed 250 participants 245 participants
6.17  (1.73) 6.27  (1.78)
Month 3 Number Analyzed 251 participants 240 participants
5.83  (1.98) 5.75  (1.89)
Month 6 Number Analyzed 229 participants 223 participants
5.55  (2.12) 5.50  (2.00)
Month 9 Number Analyzed 202 participants 197 participants
5.30  (2.14) 5.25  (2.00)
Month 12 Number Analyzed 180 participants 172 participants
4.97  (2.11) 5.10  (2.02)
Month 15 Number Analyzed 161 participants 145 participants
4.96  (2.26) 4.90  (2.13)
Month 18 Number Analyzed 146 participants 132 participants
4.77  (2.29) 5.01  (2.16)
Time Frame Safety was assessed during the 18-months study duration.
Adverse Event Reporting Description Clinical and biological safety of TRO19622 co-administered with riluzole were assessed at each visit.
 
Arm/Group Title Olesoxime Placebo Comparator
Hide Arm/Group Description

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Olesoxime: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid.

Riluzole: Riluzole given as add-on therapy 50mg bid.

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Placebo Comparator: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid Riluzole: Riluzole given as add-on therapy 50mg bid
All-Cause Mortality
Olesoxime Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   79/259 (30.50%)   80/253 (31.62%) 
Hide Serious Adverse Events
Olesoxime Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   68/259 (26.25%)   65/253 (25.69%) 
Blood and lymphatic system disorders     
Haemolytic anaemia  1  1/259 (0.39%)  0/253 (0.00%) 
Cardiac disorders     
Myocardial infarction  1  0/259 (0.00%)  2/253 (0.79%) 
Atrial fibrillation  1  1/259 (0.39%)  0/253 (0.00%) 
Atrial flutter  1  0/259 (0.00%)  1/253 (0.40%) 
Cardiac arrest  1  1/259 (0.39%)  0/253 (0.00%) 
Cardio-respiratory arrest  1  0/259 (0.00%)  1/253 (0.40%) 
Sinus tachycardia  1  1/259 (0.39%)  0/253 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/259 (0.39%)  1/253 (0.40%) 
Gastrointestinal disorders     
Dysphagia  1  4/259 (1.54%)  2/253 (0.79%) 
Acute abdomen  1  1/259 (0.39%)  0/253 (0.00%) 
Constipation  1  0/259 (0.00%)  1/253 (0.40%) 
Faecaloma  1  0/259 (0.00%)  1/253 (0.40%) 
Gastric ulcer  1  0/259 (0.00%)  1/253 (0.40%) 
Impaired gastric emptying  1  1/259 (0.39%)  0/253 (0.00%) 
Nausea  1  1/259 (0.39%)  0/253 (0.00%) 
Pneumoperitoneum  1  0/259 (0.00%)  1/253 (0.40%) 
Vomiting  1  1/259 (0.39%)  0/253 (0.00%) 
General disorders     
Application site inflammation  1  1/259 (0.39%)  0/253 (0.00%) 
Application site pain  1  1/259 (0.39%)  0/253 (0.00%) 
Death  1  0/259 (0.00%)  1/253 (0.40%) 
Fatigue  1  1/259 (0.39%)  0/253 (0.00%) 
General physical health deterioration  1  0/259 (0.00%)  1/253 (0.40%) 
Pain  1  1/259 (0.39%)  0/253 (0.00%) 
Sudden death  1  0/259 (0.00%)  1/253 (0.40%) 
Hepatobiliary disorders     
Alcoholic liver disease  1  0/259 (0.00%)  1/253 (0.40%) 
Infections and infestations     
Pneumonia  1  1/259 (0.39%)  5/253 (1.98%) 
Lobar pneumonia  1  1/259 (0.39%)  2/253 (0.79%) 
Lower respiratory tract infection  1  0/259 (0.00%)  3/253 (1.19%) 
Lung infection  1  2/259 (0.77%)  1/253 (0.40%) 
Respiratory tract infection  1  0/259 (0.00%)  2/253 (0.79%) 
Bronchopneumonia  1  0/259 (0.00%)  1/253 (0.40%) 
Cellulitis  1  0/259 (0.00%)  1/253 (0.40%) 
Gastroenteritis  1  0/259 (0.00%)  1/253 (0.40%) 
Gastrointestinal fungal infection  1  1/259 (0.39%)  0/253 (0.00%) 
Parotitis  1  0/259 (0.00%)  1/253 (0.40%) 
Post procedural infection  1  1/259 (0.39%)  0/253 (0.00%) 
Sepsis  1  0/259 (0.00%)  1/253 (0.40%) 
Injury, poisoning and procedural complications     
Fall  1  0/259 (0.00%)  2/253 (0.79%) 
Chest injury  1  1/259 (0.39%)  0/253 (0.00%) 
Craniocerebral injury  1  0/259 (0.00%)  1/253 (0.40%) 
Device breakage  1  1/259 (0.39%)  0/253 (0.00%) 
Face injury  1  0/259 (0.00%)  1/253 (0.40%) 
Femoral neck fracture  1  1/259 (0.39%)  0/253 (0.00%) 
Femur fracture  1  0/259 (0.00%)  1/253 (0.40%) 
Foot fracture  1  1/259 (0.39%)  0/253 (0.00%) 
Head injury  1  1/259 (0.39%)  0/253 (0.00%) 
Joint sprain  1  0/259 (0.00%)  1/253 (0.40%) 
Lumbar vertebral fracture  1  0/259 (0.00%)  1/253 (0.40%) 
Poisoning deliberate  1  1/259 (0.39%)  0/253 (0.00%) 
Rib fracture  1  1/259 (0.39%)  0/253 (0.00%) 
Traumatic brain injury  1  1/259 (0.39%)  0/253 (0.00%) 
Traumatic intracranial haemorrhage  1  1/259 (0.39%)  0/253 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/259 (0.39%)  0/253 (0.00%) 
Aspartate aminotransferase increased  1  1/259 (0.39%)  0/253 (0.00%) 
Gamma-glutamyltransferase increased  1  1/259 (0.39%)  0/253 (0.00%) 
Hepatic enzyme increased  1  1/259 (0.39%)  0/253 (0.00%) 
Troponin increased  1  1/259 (0.39%)  0/253 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/259 (0.77%)  1/253 (0.40%) 
Malnutrition  1  2/259 (0.77%)  0/253 (0.00%) 
Hypokalaemia  1  1/259 (0.39%)  0/253 (0.00%) 
Hyponatraemia  1  1/259 (0.39%)  0/253 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  0/259 (0.00%)  1/253 (0.40%) 
Pain in extremity  1  1/259 (0.39%)  0/253 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma  1  0/259 (0.00%)  1/253 (0.40%) 
Squamous cell carcinoma  1  0/259 (0.00%)  1/253 (0.40%) 
Tongue neoplasm malignant stage unspecified  1  1/259 (0.39%)  0/253 (0.00%) 
Uterine leiomyoma  1  0/259 (0.00%)  1/253 (0.40%) 
Nervous system disorders     
Transient ischaemic attack  1  0/259 (0.00%)  2/253 (0.79%) 
Aphasia  1  0/259 (0.00%)  1/253 (0.40%) 
Areflexia  1  0/259 (0.00%)  1/253 (0.40%) 
Cerebral haematoma  1  1/259 (0.39%)  0/253 (0.00%) 
Cerebrovascular accident  1  0/259 (0.00%)  1/253 (0.40%) 
Dizziness  1  0/259 (0.00%)  1/253 (0.40%) 
Embolic stroke  1  0/259 (0.00%)  1/253 (0.40%) 
Hypercapnic encephalopathy  1  1/259 (0.39%)  0/253 (0.00%) 
Meningorrhagia  1  1/259 (0.39%)  0/253 (0.00%) 
Psychiatric disorders     
Anxiety  1  3/259 (1.16%)  0/253 (0.00%) 
Depression  1  1/259 (0.39%)  0/253 (0.00%) 
Completed suicide  1  0/259 (0.00%)  1/253 (0.40%) 
Sleep disorder  1  0/259 (0.00%)  1/253 (0.40%) 
Renal and urinary disorders     
Urinary retention  1  1/259 (0.39%)  2/253 (0.79%) 
Renal colic  1  1/259 (0.39%)  0/253 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  14/259 (5.41%)  8/253 (3.16%) 
Pulmonary embolism  1  8/259 (3.09%)  7/253 (2.77%) 
Dyspnoea  1  5/259 (1.93%)  6/253 (2.37%) 
Pneumonia aspiration  1  3/259 (1.16%)  5/253 (1.98%) 
Lung disorder  1  4/259 (1.54%)  1/253 (0.40%) 
Acute respiratory failure  1  2/259 (0.77%)  0/253 (0.00%) 
Atelectasis  1  1/259 (0.39%)  1/253 (0.40%) 
Bronchial obstruction  1  0/259 (0.00%)  2/253 (0.79%) 
Choking  1  1/259 (0.39%)  1/253 (0.40%) 
Increased bronchial secretion  1  0/259 (0.00%)  2/253 (0.79%) 
Respiratory arrest  1  1/259 (0.39%)  1/253 (0.40%) 
Bronchial secretion retention  1  1/259 (0.39%)  0/253 (0.00%) 
Bronchospasm  1  0/259 (0.00%)  1/253 (0.40%) 
Cough  1  0/259 (0.00%)  1/253 (0.40%) 
Haemoptysis  1  0/259 (0.00%)  1/253 (0.40%) 
Haemothorax  1  1/259 (0.39%)  0/253 (0.00%) 
Hypoventilation  1  0/259 (0.00%)  1/253 (0.40%) 
Nocturnal dyspnoea  1  1/259 (0.39%)  0/253 (0.00%) 
Respiratory tract congestion  1  0/259 (0.00%)  1/253 (0.40%) 
Surgical and medical procedures     
Mechanical ventilation  1  2/259 (0.77%)  0/253 (0.00%) 
Hysterectomy  1  0/259 (0.00%)  1/253 (0.40%) 
Vascular disorders     
Deep vein thrombosis  1  3/259 (1.16%)  2/253 (0.79%) 
Aortic dissection  1  0/259 (0.00%)  1/253 (0.40%) 
Circulatory collapse  1  1/259 (0.39%)  0/253 (0.00%) 
Embolism  1  0/259 (0.00%)  1/253 (0.40%) 
Pelvic venous thrombosis  1  1/259 (0.39%)  0/253 (0.00%) 
Phlebitis  1  0/259 (0.00%)  1/253 (0.40%) 
Thrombophlebitis  1  1/259 (0.39%)  0/253 (0.00%) 
Venous thrombosis limb  1  0/259 (0.00%)  1/253 (0.40%) 
1
Term from vocabulary, MedDRA, version 11.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olesoxime Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   98/259 (37.84%)   101/253 (39.92%) 
Gastrointestinal disorders     
Diarrhoea  1  27/259 (10.42%)  15/253 (5.93%) 
Nausea  1  15/259 (5.79%)  16/253 (6.32%) 
Infections and infestations     
Bronchitis  1  10/259 (3.86%)  15/253 (5.93%) 
Nasopharyngitis  1  22/259 (8.49%)  36/253 (14.23%) 
Injury, poisoning and procedural complications     
Fall  1  26/259 (10.04%)  19/253 (7.51%) 
Nervous system disorders     
Headache  1  19/259 (7.34%)  18/253 (7.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/259 (2.70%)  15/253 (5.93%) 
Vascular disorders     
Hypertension  1  7/259 (2.70%)  13/253 (5.14%) 
1
Term from vocabulary, MedDRA, version 11.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00868166    
Other Study ID Numbers: WN29853
EudraCT Number:2008-007320-25
TRO19622 CL E Q 1015-1 ( Other Identifier: trophos id )
First Submitted: March 23, 2009
First Posted: March 24, 2009
Results First Submitted: November 24, 2014
Results First Posted: February 15, 2019
Last Update Posted: February 25, 2020