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

NCT ID: NCT01232738

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-05-31

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.

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

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rasagiline

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

Group Type: EXPERIMENTAL

rasagiline

Intervention Type: DRUG

rasagiline 2 mg daily for 12 months

Interventions

rasagiline

rasagiline 2 mg daily for 12 months

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western ALS Study Group

UNKNOWN

Sponsor Role: collaborator

Yunxia Wang, MD

OTHER

Sponsor Role: lead

Responsible Party

Yunxia Wang, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yunxia Wang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Phoenix Neurological Institute

Phoenix, Arizona, United States

California Pacific Medical Center

San Francisco, California, United States

University of Iowa

Iowa City, Iowa, United States

University Of Kansas Medical Center

Kansas City, Kansas, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Tennessee

Memphis, Tennessee, United States

The Methodist Hospital System

Houston, Texas, United States

McGill University

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

11922

Identifier Type: -

Identifier Source: org_study_id