Back to resultsA Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fasudil
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fasudil
Arm Description
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.
Outcomes
Primary Outcome Measures
The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score
Secondary Outcome Measures
Survival time
Full Information
NCT ID
NCT01935518
First Posted
September 1, 2013
Last Updated
September 5, 2013
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01935518
Brief Title
A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Official Title
A Historical Placebo Controlled Screening Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fasudil
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Fasudil
Intervention Description
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.
Primary Outcome Measure Information:
Title
The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score
Time Frame
Month 3, 6
Secondary Outcome Measure Information:
Title
Survival time
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Forced Vital Capacity
Time Frame
Baseline, Month 3 and 6
Title
SF-36
Time Frame
Baseline, Month 3 and 6
Title
Cognitive function
Description
verbal fluency and Frontal Behavioral Inventory Scale (FBI)
Time Frame
Baseline, Month 3 and 6
Title
Safety Labs
Description
blood test including blood RT, liver function, renal function, serum electrolyte, myocardial enzyme, glucose and coagulation function
Time Frame
Baseline, Month 0.5, 3, 3.5, 6
Title
Adverse Events
Time Frame
Month 0.5, 3, 3.5, 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsheng Fan, MD, PhD
Phone
0086-15611908107
Email
dsfan@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan, MD, PhD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolu Liu, MD
Phone
0086-1082265032
Email
liuxiaolupku@gmail.com
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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