NeuroMetrix Announces That Top-Line Results from a Randomized Controlled Trial of Quell® for Treatment of Fibromyalgia to be...
June 09 2021 - 8:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today reported that top-line
results from a randomized controlled trial of Quell in patients
with fibromyalgia will be presented at two upcoming pain medicine
conferences.
The double-blind, randomized, sham-controlled trial was
conducted at the Center for Pain Management, Brigham and Women's
Hospital (Boston, MA); ClinicalTrials.gov identifier NCT03714425. A
total of 119 subjects with fibromyalgia were enrolled and
randomized to a standard (active) or modified (sham) Quell device
for 3-months of at-home use. The average age of study subjects was
50 years, 93% were female and the average duration of chronic pain
was 18 years. Most subjects had moderate to severe
fibromyalgia.
A poster titled "Outcome of TENS for Fibromyalgia: Randomized
Sham-Controlled Trial" will be presented at the International
Association for the Study of Pain (IASP) 2021 Virtual World
Congress on Pain June 9-11 & 16-18. Key reported results
include:
- In the intention-to-treat (ITT) population, the treatment
difference in the Patient Global Impression of Change (PGIC,
primary endpoint) was not significant (sham 3.24 ± 0.26, active
3.58 ± 0.25, p=0.351). However, in a pre-specified subgroup
analysis of subjects with elevated baseline pain sensitivity, the
active treatment group exhibited a significant and clinically
meaningful improvement compared to sham (sham 3.09±0.40, active
4.24 ± 0.37, p=0.032).
- Several secondary endpoints were positive in the ITT
population. The reduction in the mean FIQR Total Score was
significantly greater for active treatment (-14.0 ± 2.1) compared
to sham (-6.6 ± 2.2), p=0.001. The Brief Pain Inventory (BPI)
interference subscale and the painDETECT questionnaire (PDQ) also
exhibited significant improvements compared to sham.
- There were few TENS related adverse events, and all were minor
and self-limited.
An oral presentation titled "Baseline Pain Sensitivity Predicts
Responder Rates of Wearable TENS Use in Fibromyalgia: Analysis of a
Double-Blinded Randomized Sham-Controlled Trial" will be given at
the 3rd International Virtual Congress on Controversies in
Fibromyalgia (Fibromyalgia2021) on June 24-25. Key reported results
include:
- In the ITT population, the FIQR responder rate (≥15% reduction)
was 56% for the active device compared to 35% for sham
(p=0.029).
- In subjects with elevated baseline pain sensitivity, the PGIC
responder rate was 58% (active) versus 30% (sham), p=0.024. The
pain responder rate (≥30% reduction) was 58% (active) versus 18%
(sham), p=0.001.
"I would like to thank Dr. Robert Jamison and his colleagues at
Brigham and Women's Hospital for designing and successfully
completing this trial study despite the COVID-19 pandemic.
Fibromyalgia is a disabling chronic pain condition with an urgent
need for effective treatments without the side effects of drugs
currently used to manage the condition. We believe that Quell may
be effective in fibromyalgia and the results of this study support
this potential," said Shai N. Gozani, M.D., Ph.D., President and
CEO of NeuroMetrix. "We are particularly pleased that subjects
treated with Quell exhibited a significant improvement in FIQR over
3-months compared to sham. FIQR is a comprehensive health-related
quality of life assessment specifically designed for fibromyalgia.
The 21 clinical items comprising the FIQR have high everyday
relevance to individuals with fibromyalgia. We are also pleased
with the broad positive results in subjects with elevated pain
sensitivity, because these are the patients expected to benefit
most from nerve stimulation."
Note: The use of Quell for fibromyalgia is
investigational. The safety and effectiveness for this purpose has
not been reviewed by the United States Food and Drug Administration
(FDA).
About Fibromyalgia
Fibromyalgia is a disorder characterized by widespread chronic
pain accompanied by fatigue, sleep, cognitive, balance and mood
disturbances. It affects an estimated 2 to 6 percent of the US
population, or as many as 5 to 15 million people, and is most often
diagnosed between the ages of 30 and 50. The cause of fibromyalgia
remains unclear, but scientific studies point to abnormalities in
the way the brain processes normal sensations and pain. Although
several drugs are FDA approved for managing fibromyalgia pain,
there is an unmet need for safe and effective non-pharmacological
treatments.
About Quell
Quell is a novel transcutaneous electrical nerve stimulator
(TENS) that is indicated for symptomatic relief and management of
chronic lower extremity pain and 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 an innovation-driven company focused on the
development and global commercialization of non-invasive medical
devices for the diagnosis and treatment of pain and neurological
disorders. The Company has three commercial products. DPNCheck® is
a diagnostic device that provides rapid, point-of-care detection of
peripheral neuropathies. ADVANCE® is a diagnostic device that
provides automated, in-office nerve conduction studies for the
evaluation of focal neuropathies. Quell® is a wearable
neurostimulation device indicated for treatment of lower extremity
chronic pain. For more information, visit www.NeuroMetrix.com.
Source: NeuroMetrix, Inc.
Thomas T. HigginsSVP and Chief Financial
Officer781-314-2761neurometrix.ir@neurometrix.com
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