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

NCT01935518 | Unknown Phase 2

• 1 other identifier: PUTH-2013121
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score

  Month 3, 6

Secondary Outcomes (1)

• Survival time

  2 years

Other Outcomes (5)

• Forced Vital Capacity

  Baseline, Month 3 and 6

• SF-36

  Baseline, Month 3 and 6

• Cognitive function

  Baseline, Month 3 and 6

Study Arms (1)

Fasudil

EXPERIMENTAL

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

Interventions

Fasudil DRUG

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.

Fasudil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

fasudil

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dongsheng Fan, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Fan, MD, PhD

CONTACT

0086-15611908107; dsfan@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the department of neurology of Peking University Third Hospital

Study Record Dates

• First Submitted: September 1, 2013
• First Posted: September 5, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

CN (1)