Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).
Muscle weakness, the cardinal feature of ALS, leads to progressive loss of motor function
affecting the limbs, tongue, respiratory and pharyngeal muscles. Symptomatic treatments such
as the placement of a feeding tube, can compensate for the inability to swallow. Riluzole,
the only approved treatment for ALS, may slow disease progression but no treatment is
curative and none have improved function.
Unexpectedly, Nuedexta®, approved for the treatment of labile emotionality that occurs in
association with ALS and other neurological disorders, has been observed to improve bulbar
function, primarily speech and swallowing, in a number of neurological disorders, including
ALS. The basis for this is conjectural but likely due to a direct effect of the drug on
motor neurons in the part of the brain that controls speech and swallowing. The same part of
the brain appears to modulate the expression of emotions and interestingly the site of
action of the drug is the same as a site that has been implicated in a juvenile form of ALS.
This is a multicenter, randomized double-blind, placebo controlled, cross over study
evaluating the palliative effect of Nuedexta® on bulbar dysfunction. It is expected that
approximately 60 ALS patients from 7 clinical centers in the US will be enrolled.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| 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 |
NCT01786603 -
Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| 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 |