Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)
This trial is active, not recruiting.
|Condition||amyotrophic lateral sclerosis (als)|
|Sponsor||Yunxia Wang, MD|
|Collaborator||Western ALS Study Group|
|Start date||December 2011|
|End date||May 2013|
|Trial size||30 participants|
|Trial identifier||NCT01232738, 11922|
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 function. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS.
Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics and it is approved for use for patients with another disorder, the effectiveness of rasagiline for patients with ALS has not been tested.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Phoenix, AZ||Phoenix Neurological Institute||no longer recruiting|
|San Francisco, CA||California Pacific Medical Center||no longer recruiting|
|Iowa City, IA||University of Iowa||no longer recruiting|
|Kansas City, KS||University Of Kansas Medical Center||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|Omaha, NE||University of Nebraska Medical Center||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania||no longer recruiting|
|Memphis, TN||University of Tennessee||no longer recruiting|
|Houston, TX||The Methodist Hospital System||no longer recruiting|
|Montreal, Canada||McGill University||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The primary outcome measure is the difference in the rate of decline in function.
time frame: up to 12 months
Measure Disease progression
time frame: up to 12 months
Male or female participants from 21 years up to 80 years old.
Inclusion Criteria: 1. A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV). 2. 21 to 80 years of age inclusive. 3. VC greater or equal to 75% of predicted at screening and baseline. 4. Onset of weakness within 3 years prior to enrollment. 5. If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit. 6. 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. 7. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB). Exclusion criteria 1. Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day. 2. Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine. 3. Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen, flexeril. 4. Patients on fluoxetine or fluvoxamine. 5. Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d, citalogram > 20 mg/d or paroxetine > 30 mg/d. 6. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc). 7. Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days. 8. History of renal disease. 9. History of liver disease. 10. Current pregnancy or lactation. 11. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures. 12. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. 13. VC < 75% of predicted. 14. Receipt of any investigational drug within the past 30 days. 15. Women with the potential to become pregnant who are not practicing effective birth control.
|Official title||A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)|
|Principal investigator||Yunxia Wang, MD|
|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|
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