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

NCT01232738 | Completed Phase 2 Results DMC

• 1 other identifier: 11922
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 10

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

• Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)

  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)

  up to 12 months

Secondary Outcomes (1)

• Difference in Time to Treatment Failure

  up to 12 months

Other Outcomes (5)

• Change in JC-1 Mitochondrial Biomarkers

  Baseline, 6 months, 12 months

• Change in Mitotracker Mitochondrial Biomarkers

  Baseline, 6 months, 12 months

• Change in Percent Annexin V Mitochondrial Biomarkers

  Baseline, 6 months, 12 months

Study Arms (1)

rasagiline

EXPERIMENTAL

Treated for 12 months with rasagiline 2mg orally, once daily.

Drug: rasagiline

Interventions

rasagiline DRUG

rasagiline 2 mg daily for 12 months

rasagiline

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yunxia Wang, MD: lead
• Western ALS Study Group: collaborator

Study Sites (10)

Phoenix Neurological Institute

Phoenix, Arizona, 85018, United States

Location

California Pacific Medical Center

San Francisco, California, 94118, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Tennessee

Memphis, Tennessee, 38104, United States

Location

The Methodist Hospital System

Houston, Texas, 77030, United States

Location

McGill University

Montreal, Quebec, H3A 2B4, Canada

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Yunxia Wang
• Organization: UKansasMCRI

ywang@kumc.edu

913-588-6970

Study Officials

• Yunxia Wang, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: November 2, 2010
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 18, 2018
• Results First Posted: May 18, 2018

Record last verified: 2018-04

Locations

US (9); CA (1)