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Motor Neuron Disease clinical trials

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NCT ID: NCT06392126 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Personalized Antisense Oligonucleotide Therapy for A Single Participant With CHCHD10 ALS

Start date: April 16, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in CHCHD10

NCT ID: NCT06307301 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Study in ALS With Abatacept & IL-2

Start date: October 28, 2021
Phase: Phase 1
Study type: Interventional

In Amyotrophic Lateral Sclerosis (ALS), the reduction of regulatory T-lymphocyte (Treg) numbers and suppressive function correlates with rapid disease progression. The investigator completed a phase 1 study of infusions of expanded autologous Tregs in combination with subcutaneous IL-2 injections in ALS patients, which showed enhancement of Treg numbers and suppressive function in vivo. The enhanced Treg suppressive function correlated strongly with slowing and stabilization of disease progression. Drugs that enhance endogenous Treg numbers and suppressive function may also stabilize disease in ALS. This phase 1 study aims to determine whether the combination therapy of subcutaneous IL-2 and abatacept (Orencia®) is safe and well-tolerated in 6 patients with ALS, and whether the therapy enhances Treg numbers and suppressive function in vivo.

NCT ID: NCT06209515 Active, not recruiting - Parkinson Disease Clinical Trials

Sociodemographic Factors and Criminal Behaviour Preceding Neurodegenerative Disease - Retrospective Register Study

DEGERWD
Start date: January 1, 2022
Phase:
Study type: Observational

In this retrospective register study, clinically classified individuals with neurodegenerative disease from the years 2010-2021 will be verified from the clinical records from KUH and Oulu University Hospital (OUH). Based on the Finnish social security number, these individuals will be linked to the the national registers of Statistics Finland and Finnish Social and Health Data Permit Authority Findata including incomes, sociodemographic factors, education, occupation, criminal records as well as to the national registers including the bought pharmaceuticals, comorbidities and causes of death. For each study case, 10 randomly selected control cases, matched with age, sex and geographical area, will be used. The aim of the study is to examine: - 1) The prevalence of criminal and other disruptive behaviour in groups of different neurodegenerative diseases prior to and after the diagnosis - 2) Changes in employment, residency,income, and marital status prior to and after the neurodegenerative disease diagnosis - 3) Hospital diagnoses and reimbursable drugs prior to and after the diagnosis - 4) Causes of death in patients with neurodegenerative disease to study excess mortality of the patients

NCT ID: NCT05981040 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis

Start date: October 27, 2023
Phase: Phase 2
Study type: Interventional

ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects with ALS.

NCT ID: NCT05889572 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral Sclerosis

IASO
Start date: June 8, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this pilot study is to assess the safety and tolerability of multiple doses of MaaT033 in ALS patients and to analyze the gut microbiota composition and evolution before considering a larger randomized controlled efficacy study.

NCT ID: NCT05508074 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)

Start date: December 2, 2022
Phase: Phase 2
Study type: Interventional

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 100 mg. This clinical trial is an exploratory study, designed to show a signal of efficacy of IFB-088 through ALSFRS-R, MITOS and King's College. Respiratory function will be followed through SVC. Biomarkers and quality of life will also be evaluated throughout the study. Patients will be treated over a 6-month period. After a screening/consent visit, patients will undergo clinic visits at randomisation (V0), at 2 weeks (V1), and at months 1 (V2), 3 (V3) and 6 (V4). One week after V0, the patient will undergo urine analysis (dipstick)and blood sampling for measurement of creatinine , as well as blood sampling for measurement of creatinine and calculation of eGFR at months 2, 4 and 5. At the V2 visit, in addition to other assessments, patients will undergo blood sampling for PK measurements and urine sampling for crystalluria examination. Blood and urine chemistry, as well as physical examination and vital signs assessment to assess safety will be performed at each visit for safety purpose and crystalluria examination will be repeated at the follow-up visit, performed one month ± one week after V4.

NCT ID: NCT05407324 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

DAZALS
Start date: November 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

NCT ID: NCT05357950 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

PARADIGM
Start date: May 31, 2022
Phase: Phase 2
Study type: Interventional

69 subjects with ALS will be enrolled in the study and randomized at a 2:1 ratio to receive the study drug or placebo tablets. Randomization sequences will be in random block sizes and stratified for ENCALS risk category [high risk ≥ -4.5 vs. low risk < -4.5], and for background ALS treatment (riluzole and/or edaravone and/or sodium phenylbutyrate and/or taurursodiol) vs. no background ALS treatment. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 6 months. Subjects will be allowed to receive standard of care (SOC) treatment of approved products (i.e., riluzole and edaravone). Additionally, subjects will be allowed to receive treatment with off-label sodium phenylbutyrate and taurursodiol, which are accepted for ALS treatment. Subjects will be evaluated every 2 months for safety, tolerability (adverse events, safety laboratory, vital signs, ECG, withdrawal rates and reasons) and efficacy (e.g. biomarkers, clinical outcomes (ALSFRS-R and SVC, quality of life and survival). All subjects who complete the 6 months dosing will be switched to the active arm for a 12-month open label extension (OLE).

NCT ID: NCT05349721 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALS

CARDINALS
Start date: May 15, 2022
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy and safety of PTC857 treatment in participants diagnosed with ALS.

NCT ID: NCT05299658 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

An Open-Label Extension for the Phase 2 Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS

Start date: November 13, 2021
Phase: Phase 2
Study type: Interventional

This is an optional open-label extension to participants that have completed the clinical trial CNMAu8.205.