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A Study 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: NCT00444613
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE March 6, 2007
First Posted Date  ICMJE March 8, 2007
Last Update Posted Date December 8, 2014
Study Start Date  ICMJE April 2007
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
  • Survival rate [ Time Frame: Every 3 months. ]
  • Functional rating scale. [ Time Frame: Every 3 months. ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2007)		 Survival rate, functional rating scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
  • Manual Muscle Test (MMT) [ Time Frame: Every 3 months. ]
  • Percent-predicted forced vital capacity (%FVC) [ Time Frame: Every 3 months. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2007)		 Manual Muscle Test (MMT); percent-predicted forced vital capacity (%FVC.)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary The purpose of this study is to investigate the efficacy and confirm the safety of E0302 in patients with Amyotrophic Lateral Sclerosis (ALS) by assessing changes in scores of survival rate and functional rating scale.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE
  • Drug: E0302 (mecobalamin)
    Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.
    Other Name: mecobalamin
  • Drug: E0302 (mecobalamin)
    Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years.
    Other Name: mecobalamin
  • Drug: Placebo
    Intramuscular injection, placebo twice a week for 3.5 years.
Study Arms  ICMJE
  • Experimental: E0302 25 mg
    Intervention: Drug: E0302 (mecobalamin)
  • Experimental: E0302 50 mg
    Intervention: Drug: E0302 (mecobalamin)
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Publications *

*   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 4, 2014)		 373
Original Enrollment  ICMJE
 (submitted: March 6, 2007)		 300
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign (or affix a seal) by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
  2. Patients who are aged 20 years or older at the time of obtaining informed consent.
  3. Patients who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial Airlie House diagnostic criteria.
  4. Patients who are at stage 1 or 2 of the severity criteria for ALS.
  5. Patients within 3-year elapsed time period from disease onset at the start of observation period.
  6. Patients who can visit study site for out-patient treatment.

Exclusion Criteria:

  1. Patients who underwent tracheostomy.
  2. Patients who experienced non-invasive positive pressure ventilation.
  3. Patients whose percent-predicted forced vital capacity (%FVC) is >=60%.
  4. Patients with multiple disturbances of conduction detected by nerve conduction test.
  5. Patients with neurological symptom(s) due to vitamin B12 deficiency.
  6. Patients who initiated newly introduced riluzole therapy after starting the observation period. Or those who received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation.
  7. Patients with cognitive impairment.
  8. Pregnant women or women with a possibility of becoming pregnant.
  9. Patients or their partners who are not willing to use reliable contraception.
  10. Patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "Ministry of Health, Labor and Welfare" (MHLW) Drug Safety Dept. Notification No. 80, Drug Safety Classification Criteria for Severity of Adverse Drug Reaction by Medicinal Products, Grade 3).
  11. Patients with malignant tumor.
  12. Patients who participated in another clinical study within 12 weeks before starting the observation period.
  13. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
  14. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00444613
Other Study ID Numbers  ICMJE E0302-J081-761
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Eisai Co., Ltd.
Original Study Sponsor  ICMJE Eisai Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kazunori Saeki Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
PRS Account Eisai Inc.
Verification Date December 2014

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