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Our Research & Work
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As part of our mission to translate advances in ALS research into clinical trials for patients, NEALS performs high quality clinical trials of potentially therapeutic agents to treat ALS. NEALS also supports other projects, such as studies related to natural history, biomarkers, and the effects of ancillary treatment on disease progression. The first NEALS clinical research study was the trial of Topiramate in ALS, which was completed in 2002. Since then, NEALS has been involved with 19 investigational and observational ALS clinical research studies. NEALS currently has several ALS clinical trials recruiting volunteers.
The ALS clinical trials listed below are trials performed by NEALS members using NEALS infrastructure. Click on the title of a trial to learn more.
NEALS Trials
Currently recruiting:
Closed or no longer recruiting new subjects:
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A Multicenter Study for the Validation of Biomarkers (BIO-ALS-01) |
No longer recruiting |
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A Phase 1, Double-Blind, Placebo-Controlled, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of ISIS 333611 Administered Intrathecally to Patients with Familial Amyotrophic Lateral Sclerosis Due to Superoxide Dismutase 1 Gene Mutations |
No longer recruiting |
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An Open-Label, Safety and Tolerability, Study Evaluating
KNS-760704 in Patients with Amyotrophic Lateral Sclerosis |
No longer recruiting |
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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis |
No longer recruiting |
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A Clinical Trial of Ceftriaxone in Subjects with ALS |
No longer recruiting |
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Accurate Test of Limb Isometric Strength (ATLIS) |
Closed |
Results not yet available |
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A Phase II, Double-blind, Randomized, Placebo-controlled, Three-way crossover, Pharmacokinetic and Pharmacodynamic Study of CK 2017357 in Patients with Amyotrophic Lateral Sclerosis (ALS) |
Closed |
Results not yet available |
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A Multicenter, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Lithium in combination with Riluzole in Volunteers with Amyotrophic Lateral Sclerosis (ALS) |
Closed |
Has Results |
Data Available |
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A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS) |
Closed |
Has Results |
Data Available |
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A Randomized, Placebo-Controlled Trial of Topiramate in Amyotrophic Lateral Sclerosis |
Closed |
Has Results |
Data Available |
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Trial of Celecoxib in Amyotrophic Lateral Sclerosis |
Closed |
Has Results |
Data Available |
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A Clinical Trial of Creatine in ALS |
Closed |
Has Results |
Data Available |
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Tolerance of high-dose coenzyme Q10 in ALS |
Closed |
Has Results |
Data Available |
NEALS Committee and Task Force Work
fALS Task Force
Chair: Michael Benatar MBenatar@med.miami.edu
The fALS working group aims to encourage collaboration across investigators and other groups engaged in familial ALS research; to promote awareness of familial ALS research amongst patients with fALS and their potentially at risk family members; and to promote dialogue between the fALS patient community and investigators engaged in research. Our efforts are guided by the belief that fALS research represents a partnership between patients with fALS and their family members, clinicians involved in their care, and scientists engaged in research.
FTD Task Force
Chair: Deborah Gelinas gelinasd@trinity-health.org
The mission of the task force on Frontal Temporal Dementia (FTD) will be to better elucidate the role of Frontal Executive Dysfunction in the clinical spectrum of Amyotrophic Lateral Sclerosis (ALS). Specific aims are to:
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Establish the incidence and prevalence of FTD within various presentations of ALS.
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Arrive at a consensus for standardized assessment to be used by ALS Clinics during routine ALS clinic visits.
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Explore how the presence of frontal executive dysfunction impacts the evolution and prognosis of ALS.
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Encourage the establishment of clinical trials designed to slow or halt the progression of cognitive abnormalities and evaluate the effect of these potential treatments on other manifestations of ALS.
Research Nurse Committee
Chair: Darlene Sawicki dpulley@partners.org
The Nursing Research Committee was established to further nursing science as it relates to ALS, to foster professional development and leadership, and to influence the future of ALS research with evidence based research. The Committee encourages all nurses in NEALS to participate.
Sample Repository Committee
Chairs: Robert Bowser Robert.Bowser@chw.edu | Carol Milligan milligan@wfubmc.edu
There are a limited number of samples available to researchers, and to help evaluate their distribution, NEALS established a scientific review committee and specific review criteria to evaluate requests. The Biofluid Repository Committee of the Northeast ALS Consortium reviews all applications. Applications are judged on potential impact of study, research design and investigator. Should the committee raise concerns with an application, the applicant will be contacted to address the concerns before approval of an application.
Site Metrics Committee
Chair: James Caress jcaress@wakehealth.edu
The Site Metrics Committee aims to objectively measure site performance and to ensure fairness in site selection procedures for clinical trials.
Tissue Repository Committee
Chairs: Jonathan Glass jglas03@emory.edu | Brent Harris bth@georgetown.edu
The Tissue Repository Committee aims to develop and coordinate best practices for ALS autopsy tissue acquisition, banking, and distribution to the research community.
UMD Task Force
Chairs: Nazem Atassi natassi@partners.org | Jinsy Andrews jandrews@hfsc.org
The NEALS UMD task force is dedicated to improving care and quality of life while furthering scientific understanding and developing treatments for people with upper motor neuron (UMN) disorders, including Primary Lateral Sclerosis (PLS) and Hereditary Spastic Paraparesis (HSP). |
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