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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis (ALS)
Intervention Drug: rasagiline
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rasagiline
Hide Arm/Group Description Open label study of rasagiline at 2 mg daily for 12 months
Period Title: Overall Study
Started 36
Completed 23
Not Completed 13
Reason Not Completed
Death             3
Physician Decision             2
Lost to Follow-up             1
Withdrawal by Subject             2
Adverse Event             5
Arm/Group Title Rasagiline
Hide Arm/Group Description Open label study of 2 mg rasagiline daily
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
61.1  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
19
  52.8%
Male
17
  47.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 36 participants
Canada
3
   8.3%
United States
33
  91.7%
1.Primary Outcome
Title Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Hide Description 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)
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The placebo arm are from the randomized, controlled studies in ALS performed during 2004-2010, corrected for symptom duration.
Arm/Group Title ALSRFS-R Slope - Rasagiline ALSFRS-R - Historical Placebo Control
Hide Arm/Group Description:
Change in ALSRFS-R at 12 months
Change in slope in the Historical Placebo Control group
Overall Number of Participants Analyzed 36 478
Mean (Standard Error)
Unit of Measure: units on a scale
-1.20  (0.14) -0.94  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALSRFS-R Slope - Rasagiline, ALSFRS-R - Historical Placebo Control
Comments Difference in slope of decline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.53 to 0.02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Difference in Time to Treatment Failure
Hide Description This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation >= 23 hours/day for 14 days or more.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Failure was defined as death, endotracheal intubation, tracheostomy-assisted ventilation, or use of noninvasive ventilation 23 hours/day for 14 days or more. It is defined in years.
Arm/Group Title Difference in Time to Treatment Failure - Rasagiline Difference in Time to Treatment Failure - Historical Control
Hide Arm/Group Description:
This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or noninvasive ventilation >=23 hours/day for 14 days.
Historical Controls were from the previous ALS trials.
Overall Number of Participants Analyzed 36 203
Median (95% Confidence Interval)
Unit of Measure: years
0.9367
(0.7682 to 0.9839)
0.8963
(0.8438 to 0.9318)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Difference in Time to Treatment Failure - Rasagiline, Difference in Time to Treatment Failure - Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Change in JC-1 Mitochondrial Biomarkers
Hide Description The 12 month change in mitochondrial biomarkerJC-1 red/green fluorescence ratio. We measured at baseline, 6 months and 12 months.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 14 subjects that completed the study were able to have this biomarker analyzed.
Arm/Group Title Rasagiline
Hide Arm/Group Description:
Open label study of rasagiline at 2 mg daily for 12 months
Overall Number of Participants Analyzed 14
Mean (95% Confidence Interval)
Unit of Measure: ratio
1.92
(1.14 to 2.70)
4.Other Pre-specified Outcome
Title Change in Mitotracker Mitochondrial Biomarkers
Hide Description The 12 month change in mitochondrial biomarkerMitotracker. We measured at baseline, 6 months and 12 months.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 17 subjects that completed the study were able to have this biomarker analyzed.
Arm/Group Title Rasagiline
Hide Arm/Group Description:
Open label study of rasagiline at 2 mg daily for 12 months
Overall Number of Participants Analyzed 17
Mean (95% Confidence Interval)
Unit of Measure: Relative Fluorescent Intensity
54.14
(31.47 to 76.81)
5.Other Pre-specified Outcome
Title Change in Percent Annexin V Mitochondrial Biomarkers
Hide Description The 12 month change in mitochondrial biomarker Annexin V %. We measured at baseline, 6 months and 12 months.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 17 subjects that completed the study were able to have this biomarker analyzed.
Arm/Group Title Rasagiline
Hide Arm/Group Description:
Open label study of rasagiline at 2 mg daily for 12 months
Overall Number of Participants Analyzed 17
Mean (95% Confidence Interval)
Unit of Measure: Annexin V %
-6.67
(-20.3 to 6.7)
6.Other Pre-specified Outcome
Title Change in BCL2/BAX Mitochondrial Biomarkers
Hide Description The 12 month change in mitochondrial biomarker BCL2/BAX. We measured at baseline, 6 months and 12 months.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 subjects that completed the study were able to have this biomarker analyzed.
Arm/Group Title Rasagiline
Hide Arm/Group Description:
Open label study of rasagiline at 2 mg daily for 12 months
Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: Ratio
0.24
(0.24 to 0.27)
7.Other Pre-specified Outcome
Title Change in ORAC Mitochondrial Biomarkers
Hide Description The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 17 subjects that completed the study were able to have this biomarker analyzed.
Arm/Group Title Rasagiline
Hide Arm/Group Description:
Open label study of rasagiline at 2 mg daily for 12 months
Overall Number of Participants Analyzed 17
Mean (95% Confidence Interval)
Unit of Measure: Trolox equivalents
1028.70
(681.09 to 1376.31)
8.Other Pre-specified Outcome
Title Change in ORAC Mitochondrial Biomarkers
Hide Description The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 17 subjects that completed the study were able to have this biomarker analyzed.
Arm/Group Title Rasagiline
Hide Arm/Group Description:
Open label study of rasagiline at 2 mg daily for 12 months
Overall Number of Participants Analyzed 17
Mean (95% Confidence Interval)
Unit of Measure: umol Trolox equivalents
1028.70
(681.09 to 1376.31)
9.Other Pre-specified Outcome
Title Change in ORAC Mitochondrial Biomarkers
Hide Description The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.
Time Frame Baseline, 6 months, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 17 subjects that completed the study were able to have this biomarker analyzed.
Arm/Group Title Rasagiline
Hide Arm/Group Description:
Open label study of rasagiline at 2 mg daily for 12 months
Overall Number of Participants Analyzed 17
Mean (95% Confidence Interval)
Unit of Measure: Trolox equivalents
1028.70
(681.09 to 1376.31)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rasagiline
Hide Arm/Group Description

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

rasagiline: rasagiline 2 mg daily for 12 months
All-Cause Mortality
Rasagiline
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rasagiline
Affected / at Risk (%) # Events
Total   1/36 (2.78%)    
Injury, poisoning and procedural complications   
Fracture * [1]  1/36 (2.78%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Fractured pelvic bone
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rasagiline
Affected / at Risk (%) # Events
Total   17/36 (47.22%)    
Blood and lymphatic system disorders   
Dizziness  3/36 (8.33%)  3
Hypertension  1/36 (2.78%)  1
Gastrointestinal disorders   
Constipation  2/36 (5.56%)  2
nausea  4/36 (11.11%)  4
General disorders   
Xerostomia  1/36 (2.78%)  1
Hepatobiliary disorders   
Lab abnormality (elevated ALT)  1/36 (2.78%)  1
Nervous system disorders   
Headache  2/36 (5.56%)  2
Psychiatric disorders   
Anxiety  2/36 (5.56%)  2
Skin and subcutaneous tissue disorders   
Alopecia *  1/36 (2.78%)  1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yunxia Wang
Organization: UKansasMCRI
Phone: 913-588-6970
EMail: ywang@kumc.edu
Layout table for additonal information
Responsible Party: Yunxia Wang, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01232738    
Other Study ID Numbers: 11922
First Submitted: October 22, 2010
First Posted: November 2, 2010
Results First Submitted: November 16, 2016
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018