Fampridine-SR Improves Walking Speed in
All Types of MS in Second Phase 3 Study
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Medical Update Memo
June 11, 2008
SUMMARY
Walking speed improved significantly in a
clinical trial of 240 people with all types
of MS taking
Fampridine-SR (MS-F204, Acorda Therapeutics,
Inc.) compared with those taking inactive
placebo. Fampridine-SR is a sustained-release
formula
of 4-aminopyridine, which temporarily enhances
nerve signaling. These phase 3 study results
are reported by Acorda in a press release
dated June 2, 2008. The company is planning
to file
for approval of this drug to treat mobility
issues in MS in 2009.
DETAILS
Problems with gait (difficulty in walking)
are among the most common mobility limitations
in MS. Fampridine-SR is a sustained-release
formula of 4-aminopyridine, which blocks
tiny pores, or potassium channels, on
the surface
of nerve fibers. This blocking ability
may improve the conduction of nerve signals
in
nerve fibers whose insulating myelin coating
has been damaged by MS. The first studies
of this potassium-blocking approach in
people
with MS were supported by the National
MS Society.
In an earlier phase 3 study of 283 people
with all types of MS, walking speed increased
by 25% compared with placebo. Two serious adverse
events led patients to discontinue Fampridine – one
case of anxiety and one seizure in a person
who developed sepsis from a urinary tract infection.
Investigators at 39 sites in the United States
and Canada recruited 240 people with all types
of MS between 18 and 70 years old with some
degree of walking disability. Participants
were randomly assigned to receive Fampridine-SR
(10 mg twice a day) or inactive placebo. The
primary endpoint of the study was response
on the Timed 25-Foot Walk, in which a patient
is directed to one end of a clearly marked
25-foot course and is instructed to walk 25
feet as quickly as possible, but safely.
A significantly greater proportion of people
taking Fampridine-SR in the trial had a consistent
improvement in walking speed compared to people
taking placebo (42.9% vs. 9.3%). Among those
taking Fampridine-SR who improved in walking
speed, there was a statistically significant
improvement in leg strength.
There were three serious adverse events that
led to participants leaving the study. In the
Fampridine-SR group, one participant had a
knee fracture, which was not considered to
be related to the treatment. In the placebo
group, one individual experienced a partial
seizure and another experienced a combination
of chest tightness and gastric reflux. Other
adverse events reported in the Fampridine-SR
treatment group included urinary tract infection,
falls, insomnia, and headache.
Further, comprehensive data from this study
will be presented at an upcoming medical meeting,
according to the press release. “We look
forward to hearing more information about this
study,” says John Richert, MD, Executive
Vice President of Research & Clinical Programs
for the National MS Society. “If the
FDA agrees that Fampridine is safe and effective,
it would bring a welcome symptomatic therapy
that has potential utility for a large number
of people with different types of MS.”
ASK MS Information System Code: 1.4.1.48.1.a
With information from the National MS Society
(USA)
National Client Services
Medical Information and Education
Offert en
français.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy,
but provides information to assist individuals in making their own decisions.
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