Clinical trials: ALS - Amyotrophic Lateral Sclerosis
ALS Caused by Superoxide Dismutase 1 (SOD1) Mutation
Long-Term Evaluation of BIIB067 (Tofersen)
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 (tofersen) in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation.
- Trial name
- NCT03070119
- Testing
- Tofersen
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 139 people
- Sponsor
- Biogen
Amyotrophic Lateral Sclerosis
A Biomarker Study to Evaluate MN-166 in Subjects With Amyotrophic Literal Sclerosis (ALS)
This is a multi-center, open-label study of MN-166 (ibudilast) in subjects with ALS. To be eligible subjects must meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a…
- Trial name
- NCT02714036
- Testing
- ibudilast
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- MediciNova
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
The Effect of RNS60 on ALS Biomarkers
Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This prompts new treatments of ALS.
- Trial name
- RNS60 (NCT03456882)
- Testing
- RNS60
- Where
- 23 sites in United States, Italy
- Volunteers
- 147 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Amyotrophic Lateral Sclerosis
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
This was a 2-part study of dexpramipexole in patients with ALS. Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels…
- Trial name
- CL201 (NCT00647296)
- Testing
- Dexpramipexole 50 mg/day, Dexpramipexole 150 mg/day, Dexpramipexole 300 mg/day
- Where
- 21 sites in United States
- Volunteers
- 194 people
- Sponsor
- Knopp Biosciences
Amyotrophic Lateral Sclerosis, Respiratory Muscle Weakness
ALS and Airway Clearance (ALSAC) Therapy
Patients will receive one of three respiratory therapy interventions for airway clearance assistance: 1) High frequency chest wall oscillation (HFCWO) and mechanical insufflation/exsufflation (MIE), 2) HFCWO or 3) MIE.
- Trial name
- ALSAC (NCT04947436)
- Testing
- High Frequency Chest Wall Oscillation, Mechanical insufflation/exsufflation
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Amyotrophic Lateral Sclerosis
Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS
The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month…
- Trial name
- MITOTARGET (NCT00868166)
- Testing
- Olesoxime, Riluzole
- Where
- 15 sites in Belgium, France and 3 more
- Volunteers
- 512 people
- Sponsor
- Hoffmann-La Roche
Amyotrophic Lateral Sclerosis
Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis
Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5% albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- NCT02479802
- Testing
- Albumin
- Where
- Spain
- Volunteers
- 13 people
- Sponsor
- Instituto Grifols, S.A.
Amyotrophic Lateral Sclerosis, ALS
Open Label Extension Study of AMX0035 in Patients With ALS
This extension study, in which all participants received active treatment (AMX0035), was designed to assess the longer-term safety and therapeutic potential of AMX0035 for participants who have completed the Main Study (AMX3500…
- Trial name
- CENTAUR-OLE (NCT03488524)
- Testing
- AMX0035
- Where
- 24 sites in United States
- Volunteers
- 90 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
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
Phase 3 Study of Dexpramipexole in ALS
The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- EMPOWER (NCT01281189)
- Testing
- Dexpramipexole
- Where
- 82 sites in United States, Australia and 9 more
- Volunteers
- 942 people
- Sponsor
- Knopp Biosciences
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
An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)
The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of tofersen in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation.
- Trial name
- VALOR (Part C) (NCT02623699)
- Testing
- Tofersen
- Where
- 40 sites in United States, Australia and 10 more
- Volunteers
- 176 people
- Sponsor
- Biogen
ALS
A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to determine the safety and tolerability of RNS60 in patients with Amyotrophic lateral sclerosis (ALS).
- Trial name
- NCT02525471
- Testing
- RNS60
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Sabrina Paganoni, M.D.
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
HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose
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
- NCT05136885
- Testing
- SLS-005
- Where
- United States
- Volunteers
- 161 people
- Sponsor
- Merit E. Cudkowicz, MD
Amyotrophic Lateral Sclerosis
Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis
The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant, antiapoptotic and neuroprotective properties of TUDCA…
- Trial name
- TUDCA-ALS (NCT00877604)
- Testing
- tauroursodeoxycholic acid (TUDCA)
- Where
- Italy
- Volunteers
- 34 people
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Amyotrophic Lateral Sclerosis
Impact of Nuedexta on Bulbar Physiology and Function in ALS
Nuedexta is FDA approved for the treatment of pseudobulbar affect in ALS patients and anecdotal reports of improvements in speech, salivation or swallowing have been reported.
- Trial name
- NCT03883581
- Testing
- dextromethorphan HBr and quinidine sulfate
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- University of Florida
Amyotrophic Lateral Sclerosis
Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body.
- Trial name
- tDCS_MND (NCT03293394)
- Testing
- Anodal bilateral motor cortex and cathodal spinal tDCS
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Amyotrophic Lateral Sclerosis
Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis
- Trial name
- ADOREXT (NCT05866926)
- Testing
- FAB122
- Where
- Spain
- Volunteers
- 201 people
- Sponsor
- Ferrer Internacional S.A.