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Phase 3 clinical trials of injectable DaxibotulinumtoxinA for cases of cervical dystonia were on as ASPEN-1 study. The results are heartening and it has met all the primary and secondary endpoints outlined in the study, Revance Therapeutics has revealed.
Injectable daxibotulinumtoxinA
for cervical dystonia
The said drug in an
injection form has been found to decrease the frequency of cervical dystonia
attacks by up to 50% annually, the company stated in a news release.
The trial investigator
Joseph Jankovic, MD, professor of neurology, Baylor College of Medicine,
Houston, Texas said:
"I was delighted
to see both the degree and duration of relief that DaxibotulinumtoxinA for
Injection provided trial subjects in ASPEN-1,"

He continued:
"Currently, most
patients with cervical dystonia visit their physician 3 to 4 times a year for
injections, which places a heavy burden on patients' time and schedule. Often,
the treatment effect wears off between injections, significantly impacting the
quality of their work and personal lives,"
"If a treatment
could offer a longer duration of effect, thus requiring fewer trips each year for
reinjection, I imagine patients would find this quite beneficial,"
The ASPEN-1 study
In the study, 301
patients with cervical dystonia from 60 clinical places in the USA, Canada, and
Europe were enrolled. It was a double-blind, randomized, placebo-controlled,
parallel-group study.
The participants
received either a single injection of 125 or 250 units of daxibotulinumtoxinA
or of a placebo. They were chosen randomly for it and were followed up for at least 36 weeks.
The findings found
that patients who received daxibotulinumtoxinA had a significant improvement in
the symptoms and signs of cervical dystonia. This improvement was noticeable by
around 4-6 weeks after the treatment and persisted. The improvement from
baseline on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was
clinically meaningful.
ASPEN-1 TRIAL [Source: Health Science Center Jacksonville University]
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The useful effect
persisted for 24 weeks with the lower dose and 20.3 weeks with the higher dose
of medicine.
Clinical Global
Impression of Change (CGIC) and Patients' Global Impression of Change (PGIC)
scales were used as two secondary endpoints and at 4 and 6 weeks, these showed a significant improvement compared to placebo.
DaxibotulinumtoxinA in
this trial was found to be safe and with benefits lasting for up to 36 weeks. No
serious treatment-related adverse events were encountered. The most common
treatment-related adverse events were pain and erythema at the site of injection
and a transient headache. Muscle weakness and dysphagia were rare.
The result of the
company’s ASPEN-OLS phase 3, open-label, long-term safety trial would be
available in 2021.
What is cervical
dystonia?
Cervical dystonia is a
painful condition that causes the head to twist in different directions. It is also
called spasmodic torticollis. These involuntary head movements might be chin to
shoulders (common), ear to shoulders, chin straight up, or chin straight down.
There might be a combination of these movements in one patient. Sometimes,
jerking head movements are also seen. Neck pain radiating into the shoulders or
headaches are also felt. The severity would vary from mild to disabling.
Cervical dystonia [Source: Pacific NeuroScience Institute]
The cause is unknown
but family history is elicited in some. Past history of injuries in the area
or stress is found. It is seen in 40-60 years of age and more common in women. Clinical
examination suffices for diagnosis but some blood tests and MRI may be needed
to rule out other conditions. There is no cure but spontaneous regressions are
known. Recurrences are also seen. Botulinum toxin and some oral medicines help.
Tricks such as touching the opposite side of the face or back of head sometimes stop
the dystonia temporarily. Hot fomentation and massages might help in relaxation
and exercises to strengthen local muscles might have some benefit. Stress
management is also of use. Deep brain stimulation and some other surgical
methods also assist in the control of dystonia. Support groups also help in reducing
the feeling of isolation and depression.
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