Status:
COMPLETED
Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Yunxia Wang, MD
Collaborating Sponsors:
Western ALS Study Group
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle ...
Detailed Description
The specific aim of this screen study is to determine whether rasagiline is safe in this patient population and if the drug has the potential to slow ALS disease progression
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).
- 21 to 80 years of age inclusive.
- VC greater or equal to 75% of predicted at screening and baseline.
- Onset of weakness within 3 years prior to enrollment.
- If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
- Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test.
- Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
- Exclusion criteria
- Requirement for tracheotomy ventilation or non-invasive ventilation for \> 23 hours per day.
- Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
- Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen, flexeril.
- Patients on fluoxetine or fluvoxamine.
- Patients taking amitriptyline \> 50 mg/d, trazodone and sertraline \> 100 mg/d, citalogram \> 20 mg/d or paroxetine \> 30 mg/d.
- Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
- Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
- History of renal disease.
- History of liver disease.
- Current pregnancy or lactation.
- Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
- History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
- VC \< 75% of predicted.
- Receipt of any investigational drug within the past 30 days.
- Women with the potential to become pregnant who are not practicing effective birth control.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01232738
Start Date
December 1 2011
End Date
May 1 2013
Last Update
May 18 2018
Active Locations (10)
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1
Phoenix Neurological Institute
Phoenix, Arizona, United States, 85018
2
California Pacific Medical Center
San Francisco, California, United States, 94118
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
University Of Kansas Medical Center
Kansas City, Kansas, United States, 66160