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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01935518
• Date of registration: 01/09/2013
• Prospective Registration: Yes
• Primary sponsor: Peking University Third Hospital
• Public title: A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
• Scientific title: A Historical Placebo Controlled Screening Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: September 2013
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01935518
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Xiaolu Liu, MD

• Name: Dongsheng Fan, MD, PhD
• Affiliation: Peking University Third Hospital

• Name: Dongsheng Fan, MD, PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Fasudil

Primary Outcome(s)

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

Secondary Outcome(s)

Survival time [Time Frame: 2 years]

Secondary ID(s)

PUTH-2013121

Source(s) of Monetary Support

Please refer to primary and secondary sponsors