NeuroMetrix Reports that Quell® is to be Evaluated for Chemotherapy-Induced Peripheral Neuropathy in NIH-Funded Clinical Tri...
August 20 2020 - 2:11PM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell
device will be used in an NIH-funded, multi-site randomized
controlled trial (RCT) of the efficacy of transcutaneous electrical
nerve stimulation (TENS) for chemotherapy-induced peripheral
neuropathy (CIPN). The principle investigator is Dr. Jennifer
Gewandter of the University of Rochester School of Medicine and
Dentistry. The trial leverages the National Cancer Institute (NCI)
Community Oncology Research Program (NCORP).
About 650,000 cancer patients receive chemotherapy annually in
the United States. CIPN is a disabling complication that occurs in
many patients treated with common chemotherapeutic drugs such as
vincristine, paclitaxel and cisplatin. A recently published
systematic analysis reported that CIPN prevalence was 68% the first
month after chemotherapy and 30% six-months after chemotherapy.
CIPN symptoms include burning/shooting pain, tingling, cramping,
and numbness in the hands and feet. CIPN is also associated with
impaired balance, walking, and sleep, decreased quality of life,
and increased risk of falls. There are few treatment options and
those that are used have limited effectiveness and may cause
serious side effects.
TENS is a safe, non-pharmacologic pain relief approach. It has
been shown to be effective for neuropathic pain but has not been
extensively evaluated in CIPN. Quell is an advanced, wearable TENS
device that is FDA cleared for symptomatic relief and management of
chronic pain. In a recently published single-arm, open label pilot
study by Dr. Gewandter and colleagues, a majority of CIPN patients
reported improved symptoms following 6-weeks of Quell use. See
https://www.ncbi.nlm.nih.gov/pubmed/30151681 for further
details.
The current study is a phase II, multi-site, double blinded,
sham-controlled RCT. A total of 150 patients with CIPN will be
enrolled. The subjects will be randomized to an active or sham
Quell device for 6-weeks. Subjects in both arms will be instructed
to wear their device for 5 hours each day. The primary outcome
measure is the baseline to 6-week change in the CIPN20, which is a
composite measure of a cancer patients' experience of symptoms and
functional limitations related to CIPN. Secondary outcomes include
individual CIPN symptoms and objective measures of central
descending pain inhibition, lower limb sensation threshold, and
balance. Complete study details are available at
https://clinicaltrials.gov/ct2/show/NCT04367480.
"We are pleased that Dr. Gewandter and her colleagues have
chosen to use Quell for this important NIH-funded clinical trial.
CIPN is a common dose-limiting side effect of chemotherapy that
adversely impacts quality of life for many cancer survivors," said
Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix.
"This rigorous RCT will inform future clinical research and use of
TENS, and Quell in particular, for CIPN.”
Note: The use of Quell technology for CIPN is
investigational only. The safety and effectiveness for this purpose
has not been reviewed by the United States Food and Drug
Administration.
About Quell
Quell is a novel transcutaneous electrical nerve stimulator
(TENS) for the symptomatic relief and management of chronic pain
that is available over-the-counter. It is a wearable device that
can be used during the day while active and at night while
sleeping. Quell users can personalize and manage therapy discreetly
via the Quell app. Quell also offers health tracking metrics
relevant to chronic pain sufferers. Quell users can synchronize
their data with the Quell Health Cloud®, which provides customized
feedback and powers a large chronic pain outcomes database. Visit
QuellRelief.com for more information.
About NeuroMetrix
NeuroMetrix is a leading developer and manufacturer of
diagnostic and therapeutic neurostimulation-based medical devices
that are used throughout the world. The Company has three FDA
cleared commercial products. DPNCheck® is a point-of-care test that
is used to evaluate peripheral neuropathies. ADVANCE™ is a
point-of-care device that provides nerve conduction studies as an
aid in diagnosing and evaluating patients suspected of having focal
or systemic neuropathies. Quell® 2.0 is a wearable, mobile app
enabled, neurostimulation device indicated for symptomatic relief
and management of chronic pain and is available over-the-counter.
The Company maintains an active, industry-leading R&D program.
For more information, visit NeuroMetrix.com.
NeuroMetrix, Inc.Thomas T. Higgins, 781-314-2761SVP and Chief
Financial Officerneurometrix.ir@neurometrix.com
Source: NeuroMetrix, Inc.
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