Amyotrophic Lateral SclerosisPhase 2NCT00326625
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing 40 mg glatiramer acetate in people with Amyotrophic Lateral Sclerosis, run by Teva Pharmaceutical Industries, Ltd. at 7 sites in 6 countries.
Trial summary
Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- 40 mg glatiramer acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 27 Jul 2006to 17 Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
- Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
- Slow VC test equal or greater than 70% of the predicted value.
- The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
- Stable dose of riluzole for at least 8 weeks prior to screening.
- Age - 18-70 (inclusive).
Who cannot join
- The use of invasive or non-invasive ventilation.
- Subject having undergone gastrostomy.
- Subject with any clinically significant or unstable medical condition.
- Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
- Additional criteria per protocol.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
About this study
Official title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- 40 mg glatiramer acetate, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg glatiramer acetateDrug
parenteral drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 40 mg glatiramer acetate (GA) | Experimental | Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day. Receives: Drug: 40 mg glatiramer acetate |
| Placebo | Placebo comparator | Pre-filled syringe of matching placebo, administered subcutaneously once a day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)
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.
Measured: Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52
Secondary outcomes (1)
Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation
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.
Measured: Baseline up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study start27 Jul 2006
- Primary completion17 Jun 2008
- Study completion17 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceutical Industries, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merav Bassan, PhD., Study chair, Teva Pharmaceuticals Industries LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326625
- Sponsor's protocol ID
- ALS-GA-201
- Status last verified
- Aug 2022
- First submitted
- 16 May 2006
- Last updated
- 3 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT00326625
- Acronym / sponsor ID
- ALS-GA-201
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Teva Pharmaceutical Industries, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2006 (actual)
- Primary completion
- 17 Jun 2008 (actual)
- Study completion
- 17 Jun 2008 (actual)
- First posted
- 17 May 2006 (estimated)
- Results
- Posted 20 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 mg glatiramer acetate (GA) | Experimental | Drug: 40 mg glatiramer acetatePre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day. |
| Placebo | Placebo comparator | Drug: PlaceboPre-filled syringe of matching placebo, administered subcutaneously once a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
- Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
- Slow VC test equal or greater than 70% of the predicted value.
- The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
- Stable dose of riluzole for at least 8 weeks prior to screening.
Key exclusion criteria (5 listed)
- The use of invasive or non-invasive ventilation.
- Subject having undergone gastrostomy.
- Subject with any clinically significant or unstable medical condition.
- Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
- Additional criteria per protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 mg glatiramer acetateparenteral drug | Drug | 40 mg glatiramer acetate (GA) |
| Placebo | Drug | Placebo |
Primary outcome
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)
Time frame: 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.
1 secondary outcome
Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation
Time frame: Baseline up to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merav Bassan, PhD. study chair
Teva Pharmaceuticals Industries LTD
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 40 mg glatiramer acetate in people with Amyotrophic Lateral Sclerosis, run by Teva Pharmaceutical Industries, Ltd. at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France, Germany, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) (time frame: Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.