NN108 TopCSPN

The TopCSPN study is a multicenter, randomized, parallel-group, double-blind, placebo-controlled, Phase II clinical trial. The purpose of this study is to determine if a target daily dose of 100 milligrams of oral topiramate slows the progression of neuropathy and improves quality of life for adults age 18-80 with cryptogenic sensory peripheral neuropathy (commonly called idiopathic neuropathy), who also have symptoms of metabolic disease (such as high cholesterol, elevated blood sugar, high blood pressure, and abdominal obesity) at screening.

A variety of assessments and questionnaires will be performed during study visits to evaluate if topiramate improves neuropathy symptoms. These study visits will be conducted over a 96-week (24-month) treatment period, with in-person visits occurring every 16 weeks and monthly follow-up phone calls in between visits.

Principal Investigator: Erik Ortega, MD

Enrollment Contact
Nicole Turcotte
(602) 406-4775
[email protected]

This study is being performed to determine how many participants may have genetic forms of amyotrophic lateral sclerosis (ALS). It may also help identify which genes most commonly relate to genetic ALS, with or without a family history of the disease.

Blood samples from subjects with amyotrophic lateral sclerosis will be used to perform genetic tests in a research laboratory. The results of the testing will be used to determine how common genetic ALS is, and if there are any basic features of the disease that can predict a specific gene or genes as the cause of ALS.

Participants will be asked to complete a one-time blood draw at a one-time clinic visit.

Principal Investigator: Shafeeq Ladha, MD

Enrollment Contact
Nicole Turcotte
(602) 406-4775
[email protected]

The purpose of this study is to determine whether magnetic resonance imaging (MRI) cytography (a type of noninvasive body scan) is useful in establishing disease severity in individuals with amyotrophic lateral sclerosis (ALS).

MRI cytography will be compared to measures typically taken at clinic visits that measure motor neuron and cognitive functions to see if it may be related to disease status.

In most cases, participants will attend a one-time clinic visit, though the option of two separate study visits may be available.

Principal Investigator: Chad Quarles, PhD

Enrollment Contact
Jessie Duncan
(602) 406-1466
[email protected]

This study is being performed to provide researchers with clinical information, combined with a wide range of biospecimens, to help identify biomarkers associated with amyotrophic lateral sclerosis (ALS), and to assess therapeutic targets. Participants will be asked to participate in four clinic visits and three telephone follow-up calls.

At each clinic visit, participants will have blood (including DNA and RNA) collected and will be evaluated with assessment tools focusing on motor neuron and cognitive (memory and thinking) functions.

Of the four visits in this study, three will also involve the collection of cerebrospinal fluid (CSF), and two will involve magnetic resonance imaging (MRI) cytography (a type of noninvasive body scan). Overall, participants may be in the research study for about 18 months.

Principal Investigator: Shafeeq Ladha, MD

Enrollment Contact
Jessie Duncan
(602) 406-1466
[email protected]