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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232738
• Other study ID #: 11922
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: May 2013

Study information

• Verified date: April 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• rasagiline
rasagiline 2 mg daily for 12 months

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec
United States	The Methodist Hospital System	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University Of Kansas Medical Center	Kansas City	Kansas
United States	University of Tennessee	Memphis	Tennessee
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	Phoenix Neurological Institute	Phoenix	Arizona
United States	California Pacific Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Yunxia Wang, MD	Western ALS Study Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in JC-1 Mitochondrial Biomarkers	The 12 month change in mitochondrial biomarkerJC-1 red/green fluorescence ratio. We measured at baseline, 6 months and 12 months.	Baseline, 6 months, 12 months
Other	Change in Mitotracker Mitochondrial Biomarkers	The 12 month change in mitochondrial biomarkerMitotracker. We measured at baseline, 6 months and 12 months.	Baseline, 6 months, 12 months
Other	Change in Percent Annexin V Mitochondrial Biomarkers	The 12 month change in mitochondrial biomarker Annexin V %. We measured at baseline, 6 months and 12 months.	Baseline, 6 months, 12 months
Other	Change in BCL2/BAX Mitochondrial Biomarkers	The 12 month change in mitochondrial biomarker BCL2/BAX. We measured at baseline, 6 months and 12 months.	Baseline, 6 months, 12 months
Other	Change in ORAC Mitochondrial Biomarkers	The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.	Baseline, 6 months, 12 months
Primary	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	Difference in Time to Treatment Failure	This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation >= 23 hours/day for 14 days or more.	up to 12 months