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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Western ALS Study Group
Information provided by (Responsible Party):
Yunxia Wang, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01232738
First received: October 22, 2010
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Amyotrophic Lateral Sclerosis (ALS)
Drug: rasagiline
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • The primary outcome measure is the difference in the rate of decline in function. [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Measure Disease progression [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    Secondary Outcome measures include: changes in disease progression rate as measured by pulmonary function (the rate of decline of vital capacity, percent predicted), quality of life, safety, and survival (mortality combined with initiation of mechanical ventilations).


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rasagiline Drug: rasagiline
rasagiline 2 mg daily for 12 months

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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232738

Locations
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
Principal Investigator: Yunxia Wang, MD University of Kansas
  More Information

No publications provided

Responsible Party: Yunxia Wang, MD, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01232738     History of Changes
Other Study ID Numbers: 11922
Study First Received: October 22, 2010
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014