Amyotrophic Lateral Sclerosis (ALS)Phase 2NCT00694941
A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing ONO-2506PO in people with Amyotrophic Lateral Sclerosis (ALS), run by Ono Pharmaceutical Co., Ltd. at 25 sites in 7 countries.
Trial summary
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- ONO-2506PO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 25 sitesin 7 countries
- Study dates
- Jun 2008to Dec 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients with diagnosis of ALS over the age of 18 years.
- Previous randomization and completion of the last visits in ONO-2506POE014 study.
- Patients whom the investigator has no concern and judges tolerable for the continued treatment with ONO-2506PO and Riluzole from a risk and benefit point of view.
Who cannot join
- A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the investigator may pose an unwarranted risk to the patient
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
Germany8 sites
Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz
Berlin
Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil
Bochum
Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
Erlangen
Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
Halle
Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik
Hanover
Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
München
Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm
Ulm
Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
Wiesbarden
France6 sites
Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
Lille
Prof. Philippe Couratier, Hopital Duruytren
Limoges
Prof. Jan Pouget, Hopital de la Timone
Marseille
Prof. William Camu, Hopital de Chauliac
Montpellier
Prof. Claude Desnuelle, Hopital 1-Archet 1
Nice
Prof. Vincent Meininger, Hopital LaPitie Salpetriere
Paris
Italy3 sites
Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
Milan
Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
Pavia
Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
Torino
United Kingdom3 sites
Prof. Nigel Leigh, Academic Neuroscience Centre
London
Prof. Douglas Mitchell, Royal Preston Hospital
Preston
Dr. Chris McDermott, Royal Hallamshire Hospital
Sheffield
Belgium2 sites
Prof. Maloteaux, UCL Saint-Luc
Brussels
Prof. Wim Robberecht, UZ Leuven
Leuven
Netherlands2 sites
Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
Amsterdam
Prof. Leonard H Van Den Berg, University Medical Center Utrecht
Utrecht
Switzerland1 site
Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
Sankt Gallen
About this study
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
Read the detailed description
This is an extension study which consists of two phases:
Double-blind phase; Patients will continue to take blinded study medication, as allocated in study ONO-2506POE014 by the central randomization system, in the presence of stable standard Riluzole therapy, until un-blinding of the study results.
Open label phase; Patients who were allocated to ONO-2506PO in the ONO-2506POE014 study will be offered entry into the open label phase of ONO-2506POE015 study and will continue to take 1200 mg of ONO-2506PO for the duration of their participation in the study, in the presence of stable standard Riluzole therapy. Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- ONO-2506PO
- Keywords
- ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS
- 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.
ONO-2506PODrug
1200mg QD / 5 years
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | ONO-2506PO in the presence of Riluzole Receives: Drug: ONO-2506PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Oct 2013
Death
Measured: Oct 2013
Tracheotomy or permanent assisted ventilation
Measured: Oct 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomohiro Kuwayama, Study director, Ono Pharma UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694941
- Sponsor's protocol ID
- ONO-2506POE015
- Status last verified
- Jun 2012
- First submitted
- 6 Jun 2008
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT00694941
- Acronym / sponsor ID
- ONO-2506POE015
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- First posted
- 11 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 objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
Detailed description
This is an extension study which consists of two phases:
Double-blind phase; Patients will continue to take blinded study medication, as allocated in study ONO-2506POE014 by the central randomization system, in the presence of stable standard Riluzole therapy, until un-blinding of the study results.
Open label phase; Patients who were allocated to ONO-2506PO in the ONO-2506POE014 study will be offered entry into the open label phase of ONO-2506POE015 study and will continue to take 1200 mg of ONO-2506PO for the duration of their participation in the study, in the presence of stable standard Riluzole therapy. Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Drug: ONO-2506POONO-2506PO in the presence of Riluzole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female patients with diagnosis of ALS over the age of 18 years.
- Previous randomization and completion of the last visits in ONO-2506POE014 study.
- Patients whom the investigator has no concern and judges tolerable for the continued treatment with ONO-2506PO and Riluzole from a risk and benefit point of view.
Key exclusion criteria (1 listed)
- A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the investigator may pose an unwarranted risk to the patient
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 |
|---|---|---|
| ONO-2506PO1200mg QD / 5 years | Drug | E |
Primary outcome
Adverse Events
Time frame: Oct 2013
Death
Time frame: Oct 2013
Tracheotomy or permanent assisted ventilation
Time frame: Oct 2013
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 13 Jun 2012.
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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.
Tomohiro Kuwayama study director
Ono Pharma UK
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-2506PO in people with Amyotrophic Lateral Sclerosis (ALS), run by Ono Pharmaceutical Co., Ltd. at 25 sites in 7 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 3 inclusion and 1 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 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, France, Italy, United Kingdom, Belgium and 2 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. 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?
Adverse Events (time frame: Oct 2013). The study lists 3 primary outcomes in all. 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 13 Jun 2012.