Amyotrophic Lateral Sclerosis (ALS)Phase 2NCT00403104
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients 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 26 sites in 8 countries.
Trial summary
The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- ONO-2506PO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 26 sitesin 8 countries
- Study dates
- Nov 2006to 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)
- Onset of muscle weakness within 14 months randomization
- Concomitant standard Riluzole therapy (50mg twice daily)
Who cannot join
- Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
- Requirement for prescription drugs used for potential neuroprotective benefit -
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
Germany8 sites
Charite Campus Virchow, ALS Ambulanz
Berlin, 13353
Neurologische Universitatsklinik Bergmannsheil
Bochum, 44789
Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
Erlangen, 91054
Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
Halle, 06120
Medizinische Hochschule Hannover, Neurologische Klinik
Hanover, 30623
Interdisziplinares Zentrum fur Palliativmedizin
München
Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm
Ulm, 89081
Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
Wiesbaden, 65191
France6 sites
Hopital Roger Salengro - Clinique Neurologique, Neurologie A
Lille, 59037
Hopital Duruytren
Limoges, 87042
Hopital de la Timone
Marseille, 13005
Hopital de Chauliac
Montpellier, 34295
Hopital l-Archet 1
Nice, 06202
Hopital LaPitie Salpetriere
Paris, 75013
Italy3 sites
Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
Milan, 20149
Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
Pavia, 27100
Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
Torino, 10126
United Kingdom3 sites
Academic Neuroscience Centre
London
Royal Preston Hospital
Preston, PR29HT
University of Sheffield - Academic Neurology Unit
Sheffield
Netherlands2 sites
Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
Amsterdam
University Medial Center Utrecht
Utrecht
Austria1 site
L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
Vienna, 1100
Switzerland1 site
Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
Sankt Gallen, 9007
About this study
Official title: A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization
The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.
- 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
1200 mg QD / 18 months
ONO-2506PODrug
0 mg QD / 18 months
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | ONO-2506PO in the presence of Riluzole Receives: Drug: ONO-2506PO |
| P | Placebo comparator | Placebo 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.
Rate of decline of respiratory function determined as SVC over the 12 month treatment period
Measured: 12 months
Secondary outcomes (4)
Survival
Measured: 12, 18 months
Functional Assessment (ALSFRS-R)
Measured: 12, 18 months
Muscle Strength (MRC muscle score)
Measured: 12, 18 months
Quality of Life
Measured: 12, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 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 Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403104
- Sponsor's protocol ID
- ONO-2506POE014
- Status last verified
- Jun 2012
- First submitted
- 22 Nov 2006
- Last updated
- 13 Jun 2012
- Results posted
- 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 Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization
- ClinicalTrials.gov ID
- NCT00403104
- Acronym / sponsor ID
- ONO-2506POE014
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Nov 2006 (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 determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Drug: ONO-2506POONO-2506PO in the presence of Riluzole |
| P | Placebo comparator | Drug: ONO-2506POPlacebo in the presence of Riluzole |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)
- Onset of muscle weakness within 14 months randomization
- Concomitant standard Riluzole therapy (50mg twice daily)
Key exclusion criteria (2 listed)
- Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
- Requirement for prescription drugs used for potential neuroprotective benefit -
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-2506PO1200 mg QD / 18 months | Drug | E |
| ONO-2506PO0 mg QD / 18 months | Drug | P |
Primary outcome
Rate of decline of respiratory function determined as SVC over the 12 month treatment period
Time frame: 12 months
4 secondary outcomes
Survival
Time frame: 12, 18 months
Functional Assessment (ALSFRS-R)
Time frame: 12, 18 months
Muscle Strength (MRC muscle score)
Time frame: 12, 18 months
Quality of Life
Time frame: 12, 18 months
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 Pharmaceutical Co., Ltd.
26 sites in 8 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 26 sites in 8 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 2 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 26 sites in Germany, France, Italy, United Kingdom, Belgium and 3 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?
Rate of decline of respiratory function determined as SVC over the 12 month treatment period (time frame: 12 months). 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.