Trial · NCT00326625

Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)

NCT00326625, Phase 2, Completed, Teva Pharmaceutical Industries, Ltd.; results first posted 2021-10-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS). Trials, record NCT00326625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00326625

On this page

Trial

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

Title: Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
NCT number: NCT00326625
Status: Completed
Phases: Phase 2
Enrollment: 366 participants, actual
Lead sponsor: Teva Pharmaceutical Industries, Ltd.
Conditions: Amyotrophic Lateral Sclerosis
Interventions: 40 mg glatiramer acetate, Placebo
First posted: 2006-05-17
Last updated: 2022-08-03
Results first posted: 2021-10-20

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)	Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52	The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported.
Secondary	Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation	Baseline up to 52 weeks	Composite endpoint of time to death, tracheostomy, or permanent assisted ventilation analyzed using the Cox's proportional hazards model to compare the risk of death, tracheostomy, or permanent assisted ventilation between treatment groups. The model includes center country, Riluzole© use, site of ALS onset, time from ALS onset, and baseline ALSFRS-R score, baseline slow VC and baseline BMI as covariates. Because less than 50% of participants experienced the event, the median time to event (i.e. the descriptive statistic for the day for which 50% of participants experienced the event) could not be calculated. Hence the days are reported as not available.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)	Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52	The intent-to-treat (ITT) analysis set consisted of all randomized participants who took at least one dose of the study drug.	Units on a Scale per Month	MEAN
SECONDARY	Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation	Baseline up to 52 weeks	The intent-to-treat (ITT) analysis set consisted of all randomized participants who took at least one dose of the study drug.	Days	MEDIAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)	Glatiramer Acetate 40mg	-1.05	Standard Error 0.059	Units on a Scale per Month
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)	Placebo	-1.00	Standard Error 0.058	Units on a Scale per Month
Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation	Glatiramer Acetate 40mg	NA	Inter-Quartile Range NA to NA	Days
Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation	Placebo	NA	Inter-Quartile Range NA to NA	Days

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Glatiramer Acetate 40mg	184
Overall Study	STARTED	Placebo	182
Overall Study	COMPLETED	Glatiramer Acetate 40mg	130
Overall Study	COMPLETED	Placebo	144
Overall Study	NOT COMPLETED	Glatiramer Acetate 40mg	54
Overall Study	NOT COMPLETED	Placebo	38

Source ClinicalTrials.gov

Adverse events290

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	Events
other	Constipation	Gastrointestinal disorders	Glatiramer Acetate 40mg	18	184	18
other	Constipation	Gastrointestinal disorders	Placebo	14	182	15
other	Diarrhoea	Gastrointestinal disorders	Glatiramer Acetate 40mg	17	184	23
other	Diarrhoea	Gastrointestinal disorders	Placebo	13	182	18
other	Dysphagia	Gastrointestinal disorders	Glatiramer Acetate 40mg	11	184	12
other	Dysphagia	Gastrointestinal disorders	Placebo	9	182	10
other	Nausea	Gastrointestinal disorders	Glatiramer Acetate 40mg	17	184	20
other	Nausea	Gastrointestinal disorders	Placebo	11	182	12
other	Fatigue	General disorders	Glatiramer Acetate 40mg	11	184	11
other	Fatigue	General disorders	Placebo	14	182	15

1 to 10 of 290Source ClinicalTrials.gov

See all 290 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glatiramer Acetate 40mg	22	184
Total, all-cause mortality	Placebo	17	182
Total, other adverse events	Glatiramer Acetate 40mg	167	184
Total, other adverse events	Placebo	133	182
Total, serious adverse events	Glatiramer Acetate 40mg	55	184
Total, serious adverse events	Placebo	54	182

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Glatiramer Acetate 40mg vs Placebo: deaths from any cause	Trial comparisons
Glatiramer Acetate 40mg vs Placebo: 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/NCT00326625

GET https://conductscience.org/api/trials/v1/NCT00326625/events?page=2

API reference For AI assistants