Contact: Christine Barr, RN Telephone: 215-762-5186 Email: cbarr@drexelmed.edu

Clinical Trials for Investigational Drugs:
 

AEOLUS Arimoclomol* CC-11006 Ceftriaxone		KNS-760704* Neurodex Co-enzyme Q10 Xaliproden Zenvia*

*Currently enrolling. If interested, please contact Christine Barr.
 
AEOLUS: AEOL 10150 is a manganoporphyrin antioxidant that was found to extend survival in the mouse model. This was a multi-center clinical trial, and the center was involved in this Phase I part of the study.
Status: The sponsor, Aeolus Science Inc., is currently reviewing the data and expected to make an announcement soon.
 
Arimoclomol: Arimoclomol increases production of a type of protein, known as a “heat shock protein,” that helps to protect damaged or stressed nerve cells. The center recently completed a Phase II trial of Arimoclomol in ALS patients examining the side effects of the medication and will be starting the Phase IIb trial in the fall to determine efficacy. Arimoclomol increases production of a type of protein, known as a “heat shock protein” that helps protect damaged or stressed nerve cells. Our center recently completed a phase II trial of Arimoclomol in ALS patients examining the side effects of the medication and will be starting the Phase IIb trial. The study will look at the safety of Arimoclomol and how well it is tolerated, as well as the pharmacokinetics of the drug. Approximately 15 subjects will be enrolled at Drexel University College of Medicine. The duration of the study is approximately 19 weeks and the study drug is to be taken for about 12 weeks. Subjects will receive either a placebo or Arimoclomol at one of three different dosages. This is a multi-site. The coordinating center is Massachusetts General Hospital and the sponsor is CytRx.
Status: Enrollment is currently on hold. If interested in this study and would like to be put on the list for updates, please contact Christine Barr.
 
CC-11006: Celgene Corporation is sponsoring a Phase II study to assess the safety and efficacy of a new drug CC-11006 in subjects with ALS. CC-1106 is a molecule Celgene Corp. has identified as a potential treatment for neurodegenerative diseases among other illnesses. Subjects will be randomized in a 2:2:2:1 ratio to one of three CC-11006 dose-regimens or placebo.
Status: More information will be posted on this website as soon as it becomes available.
 
Ceftriaxone*: Ceftriaxone is best known as an antibiotic that treats Lyme disease but has also shown efficacy in models of ALS. Ceftriaxone- a semi-synthetic, third generation cephalosporin antibiotic- may block glutamate toxicity by increasing the levels of a protein that reduces excess glutamate. A small trial of Ceftriaxone was recently initiated to assess any side-effects that may appear with long term administration in people with ALS. The Center of Hope is participating in this trial to look at the effect of Ceftriaxone on survival in ALS. This study is coordinated by Massachusetts General Hospital and is funded by NIH.
Status: Currently enrolling.
 
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KNS-760704*: Knopp Neurosciences is looking at the safety and tolerability of a new small molecule, KNS 760704. The drug is an optical enantiomer of a selective, high affinity dopamine agonist marketed in other neurological indications. Both KNS 760704 and the marketed agonist demonstrate neuroprotective properties independent of dopamine receptor activity, but KNS 760704 exhibits greatly reduced dopamine receptor affinity.
Status: Currently enrolling.
 
Neurodex: Neurodex is a combination of Dextromethorophan and Quinidine. This drug is directed at controlling the emotional lability (laughing and crying too easily) experienced by some people living with ALS. It is funded by Avanir Pharmaceuticals.
Status: This trial is currently active, but no longer enrolling. Current enrollment is under Zenvia.
 
Co-enzyme Q10: Co-enzyme Q10 (CoQ10) acts as an antioxidant and helps to protect the mitochondria (the energy producer of nerve cells) from damage. It has been demonstrated to increase survival in the mouse model of ALS. The Center of Hope is participating in this Phase II trial of high dose Co-Q10, which is entering the second stage of testing. The coordinating center is Columbia University and funding is through the NIH.
Status: Enrollment is complete. Data is currently being reviewed.
 
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Xaliproden: Xaliproden is a small molecule with neurotrophin-like effects. This study was a multi-centered Phase III trial sponsored by Sanofi.
Status: This trial is no longer enrolling, however subjects remain in the extension phase.
 
Zenvia*: Avanir Pharmaceuticals is sponsoring a 12 week study of an experimental drug, Zenvia, in order to assess its safety, tolerability and efficacy in the treatment of Pseudobulbar Affect (PBA) in patients with ALS. Zenvia is a novel combination product comprised of two approved drugs, dextromethorophan and quinidine. Dextromethorophan is an NMDA-selective receptor antagonist which will suppress the release of excitatory neurotransmitters. Quinidine blocks the metabolism of dextromethorophan in the body, thus maintaining sufficient dextromethorophan plasma levels. Subjects will receive either a placebo or Zenvia at one of two different dosages. Previous studies have shown this drug was successful in reducing PBA episodes.
Status: Currently enrolling.