Trial · NCT00868166

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

NCT00868166, Phase 3, Completed, Hoffmann-La Roche; results first posted 2019-02-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS. Trials, record NCT00868166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00868166

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS
NCT number: NCT00868166
Status: Completed
Phases: Phase 3
Enrollment: 512 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Amyotrophic Lateral Sclerosis
Interventions: Olesoxime, Placebo Comparator, Riluzole
First posted: 2009-03-24
Last updated: 2020-02-25
Other registries' IDs: eudract:2008-007320-25
Results first posted: 2019-02-15

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival Rate at 18 Months	From the date of randomization until the date of death or last follow-up censored at 18 months (548 days)	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.
Secondary	Percentage of Participants With Failure Over 18 Months	From randomization to the time of the first event to consider at 18 months (548 days)	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 \[NIV\])
Secondary	Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Inclusion, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	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).
Secondary	Percentage of Participants With a Global ALS FRS-R Score of <30 or Death	Month 18 (548 days)	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).
Secondary	Slow Vital Capacity (SVC) Percent Predicted	Baseline, Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	SVC as a percent of the predicted value was evaluated and reported.
Secondary	Percentage of Participants With SVC Percent Predicted <70% or Had Died Over 18 Months	Month 18 (548 days)
Secondary	Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups	Inclusion, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	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.
Secondary	The Single-Item Mc Gill Quality of Life Scale	Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival Rate at 18 Months	From the date of randomization until the date of death or last follow-up censored at 18 months (548 days)	ITT population included all randomized participants irrespective of study medication administration and eligibility status.	percentage of partcipants	NUMBER
SECONDARY	Percentage of Participants With Failure Over 18 Months	From randomization to the time of the first event to consider at 18 months (548 days)	ITT population included all randomized participants irrespective of study medication administration and eligibility status.	percentage of participants	NUMBER
SECONDARY	Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Inclusion, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	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.	score on a scale	MEAN
SECONDARY	Percentage of Participants With a Global ALS FRS-R Score of <30 or Death	Month 18 (548 days)	ITT population included all randomized participants irrespective of study medication administration and eligibility status.	percentage of participants	NUMBER
SECONDARY	Slow Vital Capacity (SVC) Percent Predicted	Baseline, Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	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.	percentage (%)	MEAN
SECONDARY	Percentage of Participants With SVC Percent Predicted <70% or Had Died Over 18 Months	Month 18 (548 days)	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.	percentage of participants	NUMBER
SECONDARY	Global Score of Manual Muscle Testing (MMT) of 34 Muscle Groups	Inclusion, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	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.	score on a scale	MEAN
SECONDARY	The Single-Item Mc Gill Quality of Life Scale	Inclusion, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15 and Month 18	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.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group72

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival Rate at 18 Months	Olesoxime		67.5	95% Confidence Interval 61.0 to 73.1	percentage of partcipants
Overall Survival Rate at 18 Months	Placebo Comparator		69.4	95% Confidence Interval 63.0 to 74.9	percentage of partcipants
Percentage of Participants With Failure Over 18 Months	Olesoxime		67.1	95% Confidence Interval 60.5 to 72.7	percentage of participants
Percentage of Participants With Failure Over 18 Months	Placebo Comparator		65.5	95% Confidence Interval 59.1 to 71.2	percentage of participants
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Olesoxime	Inclusion	39.1	Standard Deviation 4.78	score on a scale
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Placebo Comparator	Inclusion	38.2	Standard Deviation 5.25	score on a scale
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Olesoxime	Month 1	38.2	Standard Deviation 5.46	score on a scale
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Placebo Comparator	Month 1	37.2	Standard Deviation 5.59	score on a scale
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Olesoxime	Month 2	37.6	Standard Deviation 5.64	score on a scale
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)	Placebo Comparator	Month 2	36.7	Standard Deviation 6.02	score on a scale

1 to 10 of 72Source ClinicalTrials.gov

See all 72 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Olesoxime	259
Overall Study	STARTED	Placebo Comparator	253
Overall Study	COMPLETED	Olesoxime	147
Overall Study	COMPLETED	Placebo Comparator	139
Overall Study	NOT COMPLETED	Olesoxime	112
Overall Study	NOT COMPLETED	Placebo Comparator	114

Source ClinicalTrials.gov

Adverse events238

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Olesoxime	27	259
other	Diarrhoea	Gastrointestinal disorders	Placebo Comparator	15	253
other	Nausea	Gastrointestinal disorders	Olesoxime	15	259
other	Nausea	Gastrointestinal disorders	Placebo Comparator	16	253
other	Bronchitis	Infections and infestations	Olesoxime	10	259
other	Bronchitis	Infections and infestations	Placebo Comparator	15	253
other	Nasopharyngitis	Infections and infestations	Olesoxime	22	259
other	Nasopharyngitis	Infections and infestations	Placebo Comparator	36	253
other	Fall	Injury, poisoning and procedural complications	Olesoxime	26	259
other	Fall	Injury, poisoning and procedural complications	Placebo Comparator	19	253

1 to 10 of 238Source ClinicalTrials.gov

See all 238 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olesoxime	79	259
Total, all-cause mortality	Placebo Comparator	80	253
Total, other adverse events	Olesoxime	98	259
Total, other adverse events	Placebo Comparator	101	253
Total, serious adverse events	Olesoxime	68	259
Total, serious adverse events	Placebo Comparator	65	253

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30814647	DERIVED	PubMed
34433481	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Olesoxime vs Placebo Comparator: deaths from any cause	Trial comparisons
Olesoxime vs Placebo Comparator: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00868166

GET https://conductscience.org/api/trials/v1/NCT00868166/results?page=2

API reference For AI assistants