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Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00403104
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE November 22, 2006
First Posted Date  ICMJE November 23, 2006
Last Update Posted Date June 13, 2012
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
Rate of decline of respiratory function determined as SVC over the 12 month treatment period [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2006)
Rate of decline of respiratory function determined as SVC over the 12 month treatment period
Change History Complete list of historical versions of study NCT00403104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2006)
  • Survival
  • Functional Assessment (ALSFRS-R)
  • Muscle Strength (MRC muscle score)
  • Quality of Life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE 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
Brief 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 with placebo group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE
  • Drug: ONO-2506PO
    1200 mg QD / 18 months
  • Drug: ONO-2506PO
    0 mg QD / 18 months
Study Arms  ICMJE
  • Experimental: E
    ONO-2506PO in the presence of Riluzole
    Intervention: Drug: ONO-2506PO
  • Placebo Comparator: P
    Placebo in the presence of Riluzole
    Intervention: Drug: ONO-2506PO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2008)
420
Original Enrollment  ICMJE
 (submitted: November 22, 2006)
392
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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)
  2. Onset of muscle weakness within 14 months randomization
  3. Concomitant standard Riluzole therapy (50mg twice daily)

Exclusion Criteria:

  1. Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
  2. Requirement for prescription drugs used for potential neuroprotective benefit -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00403104
Other Study ID Numbers  ICMJE ONO-2506POE014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd
Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tomohiro Kuwayama Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP