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Motor Neuron Disease clinical trials

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NCT ID: NCT04322149 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Multiple Doses of AT-1501-A201 in Adults With ALS

Start date: October 16, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40 ligand (CD40L). Approximately 54 adults with Amyotrophic Lateral Sclerosis (ALS) will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites. Participants will be enrolled into one of four ascending doses.

NCT ID: NCT04313166 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001

Start date: March 19, 2020
Phase: Phase 2
Study type: Interventional

Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

NCT ID: NCT04309604 No longer available - Clinical trials for Amyotrophic Lateral Sclerosis

IC14 for ALS Patients Expanded Access

EAP
Start date: n/a
Phase:
Study type: Expanded Access

The primary objective is to provide the investigational product, IC14, at the dose of 8 mg/kg intravenously every 2 weeks for 12 weeks to 6 participants with amyotrophic lateral sclerosis (ALS). No clinical hypotheses are being tested. An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.A second extension for 14 doses every 2 weeks will be allowed if the drug is safe and well tolerated.

NCT ID: NCT04305639 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"

Start date: September 1, 2020
Phase:
Study type: Observational

The Dyspnea-ALS-Scale (DALS-15) is a uni-dimensional scale to measure dyspnea in patients with Amyotrophic Lateral Sclerosis. It can be easily and rapidly applied. The aim of this study is to investigate reliability and validity of Turkish version of the DALS-15.

NCT ID: NCT04302870 Recruiting - Clinical trials for Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial

MND-SMART
Start date: February 27, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

MND-SMART is investigating whether selected drugs can slow down the progression of motor neurone disease (MND) and improve survival. The study is 'multi-arm' meaning more than one treatment will be tested at the same time. The trial started with 3 arms; drug 1 (memantine), drug 2 (trazodone) and placebo (dummy drug). A third drug, amantadine, was added in April 2023. The first two drugs, memantine and trazodone, were removed from the trial in September 2023 due to lack of benefit. The trial currently has 2 recruiting arms; amantadine and placebo. This allows the evaluation of each drug versus placebo. Participants will be randomly allocated to either of the recruiting arms. Medicines being tested are already approved for use in other conditions. MND-SMART has an 'adaptive' design. This means medicines being studied can change according to emerging results. Treatments shown to be ineffective can be dropped and new drugs can be added over the duration of the study. This will allow many treatments, over time, to be efficiently and definitively evaluated. The medicines being tested have been selected following a rigorous process involving a systematic, unbiased, and comprehensive review of past clinical trials data, as well as information from pre-clinical research (studies in laboratories), for MND and other related neurodegenerative disorders. Drugs have been ranked for inclusion in MND-SMART by a group of independent MND experts according to set criteria. These include consideration of how the drugs work, their safety profiles, and the quality of previous studies. New drugs will be selected for investigation in MND-SMART based on continuous review of constantly updated scientific evidence as well as findings from state-of-the-art human stem cell based drug discovery platforms. These can be added by substantial amendment to the protocol.

NCT ID: NCT04297683 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

HEALEY ALS Platform Trial - Master Protocol

Start date: July 14, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT04293484 Completed - Clinical trials for Amyotrophic Lateral Sclerosis With Dementia

Cortico-Spinal tDCS as Rehabilitative Intervention in Amyotrophic Lateral Sclerosis

tDCS_MND_2
Start date: March 12, 2018
Phase: N/A
Study type: Interventional

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. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression. Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures. In this randomized, double-blind, sham-controlled study followed by an open-label phase, the investigators will evaluate whether a repetition of two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS, after a six months interval, may further outlast clinical improvement in patients with amyotrophic lateral sclerosis and can modulate intracortical connectivity, at short and long term.

NCT ID: NCT04288856 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)

Start date: April 28, 2020
Phase: Phase 1
Study type: Interventional

The primary objective is to evaluate the long-term safety and tolerability of BIIB078 in participants with chromosome 9 open reading frame 72-amyotrophic lateral sclerosis (C9ORF72-ALS). The secondary objective is to evaluate the pharmacokinectic (PK) of BIIB078 in participants with C9ORF72-ALS.

NCT ID: NCT04259255 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

Start date: October 21, 2019
Phase:
Study type: Observational

REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and protein biomarkers will also be investigated.

NCT ID: NCT04257760 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Evaluation of Palliative Care for Patients With ALS and Their Caregivers

Start date: October 8, 2020
Phase: N/A
Study type: Interventional

Rationale: Amyotrophic lateral sclerosis (ALS) is a degenerative illness which currently has no medical cure. It is routinely accompanied by a significant symptom burden including high levels of distress in patients and their caregivers. As a result, an early palliative care approach is recommended in the ALS population. Palliative care has been shown to have positive effects on the quality of life in patients and caregivers in other life limiting illness such as cancer and multiple sclerosis. Unfortunately, our understanding of the palliative care needs in ALS is limited and the efficacy of palliative care involvement is poorly understood. Furthermore, ALS patients are largely underserved by palliative care in Ontario, with <50% of ALS patients receiving palliative care even in the last year of life. Hypothesis: The investigators hypothesize that ALS patients will be agreeable to palliative care consultations and that this will improve the quality of life of patients and their caregivers. Specific Aims: This project seeks to initiate routine palliative care consultation in an interdisciplinary ALS clinic to: 1) improve patient and caregiver quality of life, 2) further understand the palliative care needs of the ALS population and 3) identify which patients and caregivers are most likely to benefit from palliative care consultation, thus guiding clinicians on when to refer in the future. Significance: This study is the first investigate the feasibility and efficacy of palliative care consultation in the ALS population, and its effects on quality of life. It has the potential to provide increased support to patients as well as caregivers. Finally, this study will aid in our understanding of the optimal time to involve palliative care in the ALS population and will act as a foundation on which larger, controlled studies can be built.