ALS Clinical Trial Research - The Northeast ALS Consortium (NEALS)

ALS CLINICAL TRIAL RESEARCH STUDIES CONDUCTED BY NEALS

THE NORTHEAST ALS CONSORTIUM (NEALS)

As part of our mission to translate advances in ALS research into clinical trials for patients as rapidly as possible, NEALS performs high quality clinical trials of potentially therapeutic agents to treat ALS. The NEALS Consortium also supports other projects, such as studies related to natural history, biomarkers, and the effects of ancillary treatment on disease progression.

The ALS clinical trials listed below are trials performed by NEALS members using NEALS infrastructure. We currently have 8 trials enrolling ALS patients. Click on the title of a trial to learn more.

For more information on the trials listed below or other ALS clinical trials, please visit http://www.clinicaltrials.gov/



Please Check out the NEALS Trial Handout for a condensed list of our current ALS trials!


Status

Clinical Research Trial

Information Last Updated   

Currently
Recruiting

A Multicenter Study for the Validation of Biomarkers

 05/06/10

Currently
Recruiting

A Clinical Trial of Ceftriaxone in Subjects with ALS
The trial is a double-blind, placebo controlled, multi-stage study to determine the safety, tolerability, and efficacy of ceftriaxone treatment in 600 people with ALS.

 05/06/10

Currently
Recruiting

The Pre-Familial ALS (pre-fALS) Study
Investigators at Emory have been pursuing the idea that it may be possible to delay or prevent the onset of disease in people who are risk for developing ALS. The pre-fALS study has been designed and is being implemented in an effort to identify risk factors that might be used to predict those at greatest risk and to characterize the earliest preclinical stages of the disease.

 05/06/10

Currently
Recruiting


Randomized, Placebo-Controlled Trial of Arimoclomol in SOD1 Positive FALS
A seamless adaptive-design phase II/III study in which participants will be evaluated twice at a study center (Emory or the MGH) and thereafter in participants’ homes by a NEALS coordinator.

 05/06/10

Currently
Recruiting

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
This Phase I study will evaluate the safety, tolerability, and pharmacokinetics of a new investigational drug, antisense oligonucleotide ISIS 333611, also known as SOD1.
 

05/06/10

Currently
Recruiting

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)
This study is a Phase II, double-blind, randomized, placebo-controlled, three-way crossover study of CK-2017357 in patients with ALS.

 05/06/10

Currently
Recruiting

Trial of High fat/High Calorie Diet versus Optimal Nutrition in Amyotrophic Lateral Sclerosis
This study is a phase II double-blind placebo-controlled clinical trial designe to study the safety, tolerability and feasibility of a high fat/high calorie diet versus high calorie diet, versus normal diet.

 05/06/10

 

Currently
Recruiting

A Phase I, Open-Label, First-in-Human, Feasibility and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis   05/06/10

 Recruiting
Healthy
Subjects
Only

 

Accurate Test of Limb Isometric Strength (ATLIS)
We have developed a new device that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength (ATLIS). This device was designed to be portable, quick, and easy to use, while generating accurate and reliable, interval level data.

 

 05/06/10

 Phase I Enrollment CompletedAn Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients with Amyotrophic Lateral Sclerosis

 05/06/10

 

Completed

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) Protocol No. LALS-001

 

 05/06/10



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