Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis
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. Motor neurons are responsible for sending signals to muscles in our
bodies to trigger movement. 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, but the effectiveness of rasagiline for patients
with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's
disease.
Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration
(FDA) and is investigational. Investigational drugs are studied to find out if they are safe
and effective in the treatment of diseases or conditions.
By doing this study, researchers hope to learn if rasagiline is safe and slows disease
progression in patients with ALS.
Funding Source - FDA OOPD (FDA Orphan Products Division).
The study is a phase II, double-blind, placebo-controlled, multicenter study of rasagiline 2mg/day. Subjects will be assigned to either active agent or placebo (3:1) for twelve months. Subjects will undergo outpatient evaluations at screening, baseline, and months 1, 2, 4, 6, 8, 10 and 12 and telephone assessments at months 3, 5, 7 and 9. There will be a close-out phone call 30 days post month 12. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02365922 -
Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
|
||
| Completed |
NCT01699451 -
DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida
|
||
| Completed |
NCT04577404 -
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 3 | |
| Terminated |
NCT03580616 -
Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Completed |
NCT02118805 -
Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
|
||
| Completed |
NCT01884571 -
Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Completed |
NCT00244244 -
A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS
|
Phase 2 | |
| Active, not recruiting |
NCT00420719 -
Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)
|
N/A | |
| Completed |
NCT02936635 -
A Study for Patients Who Completed VITALITY-ALS (CY 4031)
|
Phase 3 | |
| Withdrawn |
NCT04055532 -
Biomarkers in Neurodegenerative Diseases
|
||
| Completed |
NCT03645031 -
Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
|
N/A | |
| Completed |
NCT02559869 -
Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
|
||
| Completed |
NCT01592552 -
A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery
|
||
| Completed |
NCT00403104 -
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Recruiting |
NCT02424669 -
Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients
|
N/A | |
| Completed |
NCT02017912 -
Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS
|
Phase 2 | |
| Completed |
NCT01366027 -
PRISM Registry: Pseudobulbar Affect Registry Series
|
N/A | |
| Completed |
NCT00330681 -
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
|
Phase 3 | |
| Completed |
NCT00876772 -
Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT06351592 -
First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)
|
Phase 1 |