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

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Treatments: 1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine; Fasudil

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