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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

Brief Summary:
This study will examine whether fasudil is effective and safe in treating patients with amyotrophic lateral sclerosis (ALS).

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Fasudil Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Historical Placebo Controlled Screening Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : September 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : May 2015


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score [ Time Frame: Month 3, 6 ]

Secondary Outcome Measures :
  1. Survival time [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Forced Vital Capacity [ Time Frame: Baseline, Month 3 and 6 ]
  2. SF-36 [ Time Frame: Baseline, Month 3 and 6 ]
  3. Cognitive function [ Time Frame: Baseline, Month 3 and 6 ]
    verbal fluency and Frontal Behavioral Inventory Scale (FBI)

  4. 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

  5. Adverse Events [ Time Frame: Month 0.5, 3, 3.5, 6 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935518


Contacts
Contact: Dongsheng Fan, MD, PhD 0086-15611908107 dsfan@sina.com

Locations
China
Peking University Third Hospital Recruiting
Beijing, China, 100191
Contact: Xiaolu Liu, MD    0086-1082265032    liuxiaolupku@gmail.com   
Principal Investigator: Dongsheng Fan, MD, PhD         
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Principal Investigator: Dongsheng Fan, MD, PhD Peking University Third Hospital

Responsible Party: Fan Dongsheng, Chairman of the department of neurology of Peking University Third Hospital, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01935518     History of Changes
Other Study ID Numbers: PUTH-2013121
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Fasudil
1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protein Kinase Inhibitors
Enzyme Inhibitors