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A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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ClinicalTrials.gov Identifier: NCT01935518
Recruitment Status : Unknown
Verified September 2013 by Fan Dongsheng, Peking University Third Hospital.
Recruitment status was:  Recruiting
First Posted : September 5, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Fan Dongsheng, Peking University Third Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2013
First Posted Date  ICMJE September 5, 2013
Last Update Posted Date September 6, 2013
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2013)
The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score [ Time Frame: Month 3, 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01935518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2013)
Survival time [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2013)
  • Forced Vital Capacity [ Time Frame: Baseline, Month 3 and 6 ]
  • SF-36 [ Time Frame: Baseline, Month 3 and 6 ]
  • Cognitive function [ Time Frame: Baseline, Month 3 and 6 ]
    verbal fluency and Frontal Behavioral Inventory Scale (FBI)
  • Safety Labs [ Time Frame: Baseline, Month 0.5, 3, 3.5, 6 ]
    blood test including blood RT, liver function, renal function, serum electrolyte, myocardial enzyme, glucose and coagulation function
  • Adverse Events [ Time Frame: Month 0.5, 3, 3.5, 6 ]
Original Other Pre-specified Outcome Measures
 (submitted: September 1, 2013)
  • Forced Vital Capacity [ Time Frame: Baseline, Month 3 and 6 ]
  • SF-36 [ Time Frame: Baseline, Month 3 and 6 ]
  • Cognitive function [ Time Frame: Baseline, Month 3 and 6 ]
  • Safety Labs [ Time Frame: Baseline, Month 0.5, 3, 3.5, 6 ]
  • Adverse Events [ Time Frame: Month 0.5, 3, 3.5, 6 ]
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE A Historical Placebo Controlled Screening Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary This study will examine whether fasudil is effective and safe in treating patients with amyotrophic lateral sclerosis (ALS).
Detailed Description This is an open labeled, single center clinical study with placebo of historical researches as control. 10 patients will be enrolled in the study. The basic treatment is riluzole, 50mg twice a day. For the procedure, patients will take fasudil treatment for 14 days (30mg twice a day, intravenous). 3 months later, patients will repeat the fasudil treatment. All the patients will be followed up for 6 months. The primary outcome was the decline rate of ALSFRS-R. The secondary outcomes are the survival time, endpoint time(death, tracheotomy and continuous ventilator-dependent), forced vital capacity (FVC), the short form health survey (SF-36), evaluation of cognitive function (verbal fluency and Frontal Behavioral Inventory Scale) and safety.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: Fasudil
All the patients will take the fasudil treatment for 14 days (30mg twice a day, intravenous). 3 months later they will repeat the treatment mentioned before.
Study Arms  ICMJE Experimental: Fasudil
All the patients will take the fasudil treatment for 14 days (30mg twice a day, intravenous). 3 months later they will repeat the treatment mentioned before.
Intervention: Drug: Fasudil
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 1, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of laboratory-supported probable, probable, or definite ALS
  • Age: 18-70 years
  • Disease duration: 3-36 months
  • Forced vital capacity: at least 60% of predicted
  • ALSFRS-R: at least 30, respiratory items: at least 10
  • Decline of ALSFRS-R in the last 3 months before enrollment: 1-8
  • Must take riluzole, on a stable dose for at least 30 days prior to baseline visit with no serious side effects. They must continue the riluzole treatment for at least 6 months after enrollment.
  • Patients of childbearing potential must be using an effective method of birth control
  • Willing and able to give informed consent

Exclusion Criteria:

  • Familial ALS
  • Pregnant or nursing women
  • Patients after tracheotomy or continuous ventilator-dependent (time with non-invasive ventilator more than 22 hours per day for 7 consecutive days.)
  • After percutaneous endoscopic gastrostomy
  • Alanine Transaminase (ALT) or Aspartate Transaminase (AST): at least 3 times the upper limit of normal
  • Abnormal creatinine or urea nitrogen
  • Severe cardiac disease, pulmonary disease, hematic disease, autoimmune disease, mental disease, dementia and substance abuse
  • History of malignancy
  • History of intracranial hemorrhage
  • History of severe bleeding of digestive tract, lungs, nose and skin
  • Allergic to fasudil
  • Participating in other clinical studies or using other investigational drugs at present
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01935518
Other Study ID Numbers  ICMJE PUTH-2013121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fan Dongsheng, Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dongsheng Fan, MD, PhD Peking University Third Hospital
PRS Account Peking University Third Hospital
Verification Date September 2013

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