Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
This study has been completed.
Sponsor:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00403104
First received: November 22, 2006
Last updated: June 12, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis (ALS) |
Drug: ONO-2506PO |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
Drug Information available for:
Riluzole
U.S. FDA Resources
Further study details as provided by Ono Pharmaceutical Co. Ltd:
Primary Outcome Measures:
- Rate of decline of respiratory function determined as SVC over the 12 month treatment period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Survival [ Time Frame: 12, 18 months ] [ Designated as safety issue: Yes ]
- Functional Assessment (ALSFRS-R) [ Time Frame: 12, 18 months ] [ Designated as safety issue: No ]
- Muscle Strength (MRC muscle score) [ Time Frame: 12, 18 months ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 12, 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 420 |
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: E
ONO-2506PO in the presence of Riluzole
|
Drug: ONO-2506PO
1200 mg QD / 18 months
|
|
Placebo Comparator: P
Placebo in the presence of Riluzole
|
Drug: ONO-2506PO
0 mg QD / 18 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
- Requirement for prescription drugs used for potential neuroprotective benefit -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403104
Locations
| Austria | |
| L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien | |
| Wien, Austria, 1100 | |
| Belgium | |
| UCL Saint-Luc | |
| Brussels, Belgium | |
| UZ Leuven | |
| Leuven, Belgium, 3000 | |
| France | |
| Hopital Roger Salengro - Clinique Neurologique, Neurologie A | |
| Lille Cedex, France, 59037 | |
| Hopital Duruytren | |
| Limoges Cedex, France, 87042 | |
| Hopital de la Timone | |
| Marseille, France, 13005 | |
| Hopital de Chauliac | |
| Montpellier cedex 5, France, 34295 | |
| Hopital l-Archet 1 | |
| Nice cedex 3, France, 06202 | |
| Hopital LaPitie Salpetriere | |
| Paris, France, 75013 | |
| Germany | |
| Charite Campus Virchow, ALS Ambulanz | |
| Berlin, Germany, 13353 | |
| Neurologische Universitatsklinik Bergmannsheil | |
| Bochum, Germany, 44789 | |
| Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik | |
| Erlangen, Germany, 91054 | |
| Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie | |
| Halle, Germany, 06120 | |
| Medizinische Hochschule Hannover, Neurologische Klinik | |
| Hannover, Germany, 30623 | |
| Interdisziplinares Zentrum fur Palliativmedizin | |
| Munchen, Germany | |
| Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm | |
| Ulm, Germany, 89081 | |
| Deutsche Klinik fur Diagnostik, Fachbereich Neurologie | |
| Wiesbaden, Germany, 65191 | |
| Italy | |
| Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano | |
| Milano, Italy, 20149 | |
| Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS | |
| Pavia, Italy, 27100 | |
| Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette | |
| Torino, Italy, 10126 | |
| Netherlands | |
| Academic Medical Centre (AMC) Amsterdam - Dept of Neurology | |
| Amsterdam, Netherlands | |
| University Medial Center Utrecht | |
| Utrecht, Netherlands | |
| Switzerland | |
| Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic | |
| St. Gallen, Switzerland, 9007 | |
| United Kingdom | |
| Academic Neuroscience Centre | |
| London, United Kingdom | |
| Royal Preston Hospital | |
| Preston, United Kingdom, PR29HT | |
| University of Sheffield - Academic Neurology Unit | |
| Sheffield, United Kingdom | |
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Tomohiro Kuwayama | Ono Pharmaceutical Co. Ltd |
More Information
No publications provided
| Responsible Party: | Ono Pharmaceutical Co. Ltd |
| ClinicalTrials.gov Identifier: | NCT00403104 History of Changes |
| Other Study ID Numbers: | ONO-2506POE014 |
| Study First Received: | November 22, 2006 |
| Last Updated: | June 12, 2012 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Switzerland: Swissmedic Austria: Agency for Health and Food Safety United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Netherlands: Dutch Health Care Inspectorate |
Keywords provided by Ono Pharmaceutical Co. Ltd:
|
ONO-2506PO Amyotrophic Lateral Sclerosis ALS |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes |
Riluzole Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 18, 2013