Amyotrophic Lateral SclerosisPhase 2ALSTAR OLNCT00982150
Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing Talampanel in people with Amyotrophic Lateral Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Talampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jun 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
- Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-201.
- Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
- Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.
Who cannot join
- Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block
- Patients using any of the following:
- Chronic use of lithium carbonate
- Chronic use of mecasermin (rhIGF-1)
- Chronic use of minocycline
- Chronic use of more than 600mg/day coenzyme Q10
Show all 12Show fewer
- Chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
- Patients participating in any other investigational drug study and use of any other investigational drug
- Patients taking drugs that may interact with Talampanel
- Females who are pregnant or nursing.
- Females of child-bearing potential who do not practice medically acceptable methods of contraception.
- Any condition of the patient which the investigator feels may interfere with participation in the study.
About this study
Official title: A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)
This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Talampanel
- Keywords
- Talampanel, Open-Label Study, Amyotrophic Lateral Sclerosis
- 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.
TalampanelDrug
50mg capsules tid
| Study group | Role | What they receive |
|---|---|---|
| Talampanel | Experimental | Talampanel 50mg tid Receives: Drug: Talampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALSFRS-R
Measured: every 4 weeks
Secondary outcomes (1)
Vital Signs, ECG, Adverse Event Reports
Measured: every 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Core study unsuccessful
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 446 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
- NCT00982150
- Sponsor's protocol ID
- ALS-TAL-201-OL
- Acronym
- ALSTAR OL
- Status last verified
- Aug 2013
- First submitted
- 22 Sep 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT00982150
- Acronym / sponsor ID
- ALSTAR OL / ALS-TAL-201-OL
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Talampanel, Open-Label Study, Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Core study unsuccessful
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Sep 2009 (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.
This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talampanel | Experimental | Drug: TalampanelTalampanel 50mg tid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-201.
- Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
- Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.
Key exclusion criteria (12 listed)
- Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block
- Patients using any of the following:
- Patients participating in any other investigational drug study and use of any other investigational drug
- Patients taking drugs that may interact with Talampanel
- 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 |
|---|---|---|
| Talampanel50mg capsules tid | Drug | Talampanel |
Primary outcome
ALSFRS-R
Time frame: every 4 weeks
1 secondary outcome
Vital Signs, ECG, Adverse Event Reports
Time frame: every 26 weeks
Results and safety
The study was stopped early (reason given: Core study unsuccessful). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talampanel in people with Amyotrophic Lateral Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: Core study unsuccessful). Results are not available in the source record.
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?
ALSFRS-R (time frame: every 4 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 26 Aug 2013.