Clinical trials: Amyotrophic Lateral Sclerosis
ALS (Amyotrophic Lateral Sclerosis)
T-regulatory Cells in ALS
This study is a randomized, placebo-controlled, phase 2a trial to study the biological activity, safety, and tolerability of regulatory T Lymphocytes (Tregs) taken and expanded outside of the body and returned back to the same…
- Trial name
- Tregs in ALS (NCT04055623)
- Testing
- Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- The Methodist Hospital Research Institute
Amyotrophic Lateral Sclerosis ALS
ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments
GenieUs developed an analysis platform that will be tested to separate study participants with ALS into four categories based on blood work.
- Trial name
- NCT06429059
- Testing
- Astaxanthin, Protandim, Melatonin
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Duke University
Amyotrophic Lateral Sclerosis
A Study to Evaluate, Safety, Tolerability, and PK of AP-101 in Participants With ALS
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
- Trial name
- NCT05039099
- Testing
- AP-101
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 73 people
- Sponsor
- AL-S Pharma
Amyotrophic Lateral Sclerosis, ALS
Study of Safety, Tolerability, and Biological Activity of LAM-002A in C9ORF72-Associated Amyotrophic Lateral Sclerosis
This is a clinical trial to evaluate the safety, tolerability, and biological effect of LAM-002A in adults with C9ORF72-associated ALS (C9ALS).
- Trial name
- NCT05163886
- Testing
- LAM-002A
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- IRulya Therapeutics Inc.
Amyotrophic Lateral Sclerosis, Frontotemporal Dementia
Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)
This is an OLE study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of WVE-004 in adult participants with ALS, FTD, or mixed ALS/FTD phenotype with a documented…
- Trial name
- NCT05683860
- Testing
- WVE-004 10 mg Q12W
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 8 people
- Sponsor
- Wave Life Sciences USA, Inc.
C9orf72 Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia
Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD
The primary objective is to assess the safety and tolerability of Metformin in subjects with C9orf72 amyotrophic lateral sclerosis administered for 24 weeks.
- Trial name
- NCT04220021
- Testing
- Metformin
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Florida
Amyotrophic Lateral Sclerosis (ALS)
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24…
- Trial name
- NCT00330681
- Testing
- MCI-186
- Volunteers
- 206 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional…
- Trial name
- NCT00415519
- Testing
- MCI-186
- Volunteers
- 25 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel…
- Trial name
- NCT00424463
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 181 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores…
- Trial name
- NCT01492686
- Testing
- MCI-186, MCI-186 in open label phase
- Where
- Japan
- Volunteers
- 137 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis (ALS)
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral…
- Trial name
- NCT04577404
- Testing
- MT-1186
- Where
- 44 sites in United States, Canada and 4 more
- Volunteers
- 124 people
- Sponsor
- Shionogi
Amyotrophic Lateral Sclerosis, Alzheimer Disease
Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial
This is an open-label, biomarker-driven basket trial of baricitinib in people with subjective cognitive disorder, mild cognitive impairment, Alzheimer's disease (AD), Amyotrophic lateral sclerosis (ALS), or asymptomatic carriers…
- Conditions
- Amyotrophic Lateral Sclerosis, Alzheimer Disease, Mild Cognitive Impairment
- Trial name
- NADALS (NCT05189106)
- Testing
- Baricitinib
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Massachusetts General Hospital
ALS (Amyotrophic Lateral Sclerosis)
Ph1 T-Regulatory Cells in Amyotrophic Lateral Sclerosis
Open-label pilot study to determine the safety and tolerability of autologous CD4+ CD25+ regulatory T cells infusions with concomitant subcutaneous IL-2 injections taken 3 times per week in 3 participants with ALS.
- Trial name
- NCT03241784
- Testing
- Autologous T-regulatory lymphocytes, Interleukin-2
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Methodist Hospital Research Institute
Sialorrhea
Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands.
- Trial name
- MYSTICOL (NCT01994109)
- Testing
- MYOBLOC
- Where
- 34 sites in United States, Russia and 1 more
- Volunteers
- 187 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
ALS, Amyotrophic Lateral Sclerosis
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to determine the safety and efficacy of intrathecal treatment delivered to the cerebrospinal fluid (CSF) of mesenchymal stem cells in ALS patients every 3 months for a total of 4 injections over 12…
- Trial name
- NCT03268603
- Testing
- Autologous Adipose-derived Mesenchymal Stromal Cells
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Mayo Clinic
Amyotrophic Lateral Sclerosis
HEALEY ALS Platform Trial - Regimen G DNL343
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
- Trial name
- NCT05842941
- Testing
- DNL343
- Where
- United States
- Volunteers
- 249 people
- Sponsor
- Merit E. Cudkowicz, MD
Amyotrophic Lateral Sclerosis
HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
- Trial name
- NCT05740813
- Testing
- ABBV-CLS-7262 Dose 1, ABBV-CLS-7262 Dose 2
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- Merit E. Cudkowicz, MD
Spinal Cord Injuries, Amyotrophic Lateral Sclerosis
Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS
Rehabilitation interventions such as physical training and neural stimulation after spinal cord injury (SCI) have been shown to increase neural plasticity.
- Trial name
- NCT03851302
- Testing
- Active Remote Ischemic Conditioning, Isometric hand exercise
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Bronx VA Medical Center
Amyotrophic Lateral Sclerosis
Study of Safety and Proof of the Mechanism of BLZ945 in ALS Patients
It was an open label study to evaluate safety, tolerability and brain microglia response in participants with Amyotrophic Lateral Sclerosis (ALS) following multiple doses of BLZ945.
- Trial name
- NCT04066244
- Testing
- BLZ945
- Where
- 4 sites in United States, Finland and 1 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Amyotrophic Lateral Sclerosis, ALS
Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)
Prospective, international, randomised, double-blind, placebo controlled, multicentre, parallel group study. Patients will be randomised in a 2:1 allocation ratio to receive either IFB-088 + riluzole 100 mg or placebo + riluzole…
- Trial name
- NCT05508074
- Testing
- IFB-088 50mg/day, Riluzole 100mg/day
- Where
- 9 sites in France, Italy
- Volunteers
- 51 people
- Sponsor
- InFlectis BioScience