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Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01232738
Recruitment Status : Completed
First Posted : November 2, 2010
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Western ALS Study Group
Information provided by (Responsible Party):
Yunxia Wang, MD, University of Kansas Medical Center

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: rasagiline Phase 2

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : December 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: rasagiline
Treated for 12 months with rasagiline 2mg orally, once daily.
 Drug: rasagiline
rasagiline 2 mg daily for 12 months


Outcome Measures
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Primary Outcome Measures :
  1. Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: up to 12 months ]
    The primary outcome measure is the difference in the rate of decline in function, as detected by the ALS Functional Rating Scale - Revised (ALSFRS-R) in patients taking rasagiline compared to a database of patients from randomized clinical trials conducted during 1997-2007. Minimum score is 0 (no function) to Maximum score is 48 (normal function)


Secondary Outcome Measures :
  1. Difference in Time to Treatment Failure [ Time Frame: up to 12 months ]
    This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation >= 23 hours/day for 14 days or more.


Other Outcome Measures:
  1. Change in JC-1 Mitochondrial Biomarkers [ Time Frame: Baseline, 6 months, 12 months ]
    The 12 month change in mitochondrial biomarkerJC-1 red/green fluorescence ratio. We measured at baseline, 6 months and 12 months.

  2. Change in Mitotracker Mitochondrial Biomarkers [ Time Frame: Baseline, 6 months, 12 months ]
    The 12 month change in mitochondrial biomarkerMitotracker. We measured at baseline, 6 months and 12 months.

  3. Change in Percent Annexin V Mitochondrial Biomarkers [ Time Frame: Baseline, 6 months, 12 months ]
    The 12 month change in mitochondrial biomarker Annexin V %. We measured at baseline, 6 months and 12 months.

  4. Change in BCL2/BAX Mitochondrial Biomarkers [ Time Frame: Baseline, 6 months, 12 months ]
    The 12 month change in mitochondrial biomarker BCL2/BAX. We measured at baseline, 6 months and 12 months.

  5. Change in ORAC Mitochondrial Biomarkers [ Time Frame: Baseline, 6 months, 12 months ]
    The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232738


Locations
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United States, Arizona
Phoenix Neurological Institute
Phoenix, Arizona, United States, 85018
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94118
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University Of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38104
United States, Texas
The Methodist Hospital System
Houston, Texas, United States, 77030
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H3A 2B4
Sponsors and Collaborators
Yunxia Wang, MD
Western ALS Study Group
Investigators
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Principal Investigator: Yunxia Wang, MD University of Kansas Medical Center
More Information
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Responsible Party: Yunxia Wang, MD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01232738    
Other Study ID Numbers: 11922
First Posted: November 2, 2010    Key Record Dates
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
 Proteostasis Deficiencies
Metabolic Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs