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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01786603 |
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Date of registration:
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28/11/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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November 21, 2013 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01786603 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard Barohn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Kansas Medical Center |
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Key inclusion & exclusion criteria
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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 2 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 propoxyphene, flexeril.
4. Patients on fluoxetine or fluvoxamine.
5. Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d,
citalopram > 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. Has a diaphragm pacing device or plan on obtaining a diaphragm pacing device during
the course of the study.
9. History of renal disease.
10. History of liver disease.
11. Current pregnancy or lactation.
12. Limited mental capacity such that the patient cannot provide written informed consent
or comply with evaluation procedures.
13. History of recent alcohol or drug abuse or noncompliance with treatment or other
experimental protocols.
14. Vital Capacity (VC) < 75% of predicted.
15. Receipt of any investigational drug within the past 30 days.
16. Women with the potential to become pregnant who are not practicing effective birth
control.
17. Poorly controlled hypertensive subjects or resting systolic blood pressure (SBP) > 160
mmHg and/or diastolic (DBP) > 95 mmHg.
18. Use of BiPAP at screening.
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis (ALS)
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Intervention(s)
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Drug: Rasagiline
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Drug: Placebo
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Primary Outcome(s)
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ALS Functional Rating Scale-Revised (ALSFRS-R)
[Time Frame: ALS Functional Rating Scale-Revised (ALSFRS-R) Difference from Baseline to Month 12]
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Secondary Outcome(s)
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Change in Quality of Life
[Time Frame: Quality of Life Change from Baseline to Month 12]
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Change in Vital Capacity (VC)
[Time Frame: Vital Capacity Change from Baseline to Month 12]
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Effect of Study Drug on Apoptosis Markers
[Time Frame: Apoptosis Marker change from Baseline to Month 12]
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Effect of Study Drug on Oxidative Stress
[Time Frame: Oxidative Stress change from Baseline to Month 12]
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Difference in Survival Status Between Study Groups
[Time Frame: Survival status at Month 12]
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Number of Participants With Adverse Events
[Time Frame: Adverse Events from Baseline to Month 12]
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Secondary ID(s)
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R01FD003739
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12312
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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