ALSPhase 2ALSNCT00696332
Talampanel for Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing Talampanel in people with ALS, run by Teva Branded Pharmaceutical Products R&D, Inc. at 24 sites in 10 countries.
Trial summary
The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ALS
- What is being tested?
- Talampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 559 participants
- Where
- 24 sitesin 10 countries
- Study dates
- Sep 2008to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 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 to 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.
- Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.
- Ages 18-80 (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.
- Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).
- Females who are pregnant or nursing.
Trial locations and contacts
24 sites in 10 countries.
24 sites in 10 countries
United States7 sites
Johns Hopkins OPC - Meyer Bldg
Baltimore, Maryland, 21287
Massachusetts General Hospital-Neurology Clinical Trials Unit
Charlestown, Massachusetts, 02129
University of Kansas Medical Center - Dept of Neurology
Kansas City, Kansas, 66160
Columbia University - Neurology Institute
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
San Francisco, California, 94115
SUNY Upstate Medical University
Syracuse, New York, 13210
Canada3 sites
London Health Sciences Centre Motor Neuro Diseases Clinic
London, Ontario, N6A 5A5
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4
ALS Centre
Vancouver, British Columbia, V5Z 2G9
France3 sites
C.H.U. La Timone - Service de Neurologie
Marseille, 13385
C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
Montpellier, 34295
Hopital La Pitie Salpetriere - Federation de Neurologie
Paris, 75013
Germany3 sites
Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
Berlin, 13353
Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
Bochum, 44789
Universitaet Ulm
Ulm, 89081
Italy3 sites
Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
Lissone (MI), 20035
Centro Clinico NEMO
Milan, 20162
Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
Torino, 10126
Belgium1 site
Academic Hospital University of Leuven - ALS dept
Leuven, B-3000
About this study
Official title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.
- Conditions
- ALS
- Being tested
- Talampanel, placebo
- Keywords
- ALS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalampanelDrug
Also called AMPA antagonist
capsules Talampanel, 3 times per day, 52 weeks
TalampanelDrug
Also called AMPA antagonist
capsules Talampanel, 3 times per day, 52 weeks
placeboOther
capsules, placebo, 3 times a day, for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Talampanel 50mg | Experimental | 50mg Talampanel 3 times per day Receives: Drug: Talampanel |
| Talampanel 25mg | Experimental | 25mg Talampanel 3 times per day Receives: Drug: Talampanel |
| Placebo | Placebo comparator | placebo 3 times per day Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ALS Functional Rating Score (ALSFRS-R slope)
Measured: 52 weeks
Secondary outcomes (1)
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696332
- Sponsor's protocol ID
- ALS-TAL-201 (ALSTAR)
- Other IDs
- ALSTAR
- Acronym
- ALS
- Status last verified
- Oct 2011
- First submitted
- 10 Jun 2008
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. 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 Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT00696332
- Acronym / sponsor ID
- ALS / ALS-TAL-201 (ALSTAR)
- Conditions
- ALS
- Keywords
- ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Talampanel 50mg | Experimental | Drug: Talampanel50mg Talampanel 3 times per day |
| Talampanel 25mg | Experimental | Drug: Talampanel25mg Talampanel 3 times per day |
| Placebo | Placebo comparator | Other: placeboplacebo 3 times per day |
Who may qualify
- Ages
- 18 to 80 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 to 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.
- Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.
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.
- Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).
- Females who are pregnant or nursing.
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 |
|---|---|---|
| TalampanelAlso: AMPA antagonistcapsules Talampanel, 3 times per day, 52 weeks | Drug | Talampanel 50mg |
| TalampanelAlso: AMPA antagonistcapsules Talampanel, 3 times per day, 52 weeks | Drug | Talampanel 25mg |
| placebocapsules, placebo, 3 times a day, for 52 weeks | Other | Placebo |
Primary outcome
Change in ALS Functional Rating Score (ALSFRS-R slope)
Time frame: 52 weeks
1 secondary outcome
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
Related trials for ALS
RecruitingPhase 1
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ALS (Amyotrophic Lateral Sclerosis)
Active, not recruiting
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis)
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruitingPhase 1
Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
Amyotrophic Lateral Sclerosis ALS
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talampanel in people with ALS, run by Teva Branded Pharmaceutical Products R&D, Inc. at 24 sites in 10 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 21 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, France, Germany, Italy and 5 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in ALS Functional Rating Score (ALSFRS-R slope) (time frame: 52 weeks). 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 21 Oct 2011; AzTrials last refreshed its copy on 6 Nov 2026.