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The ALS Center at the Penn Comprehensive Neuroscience Center
is actively involved in research projects related
to symptom management, novel therapeutics, imaging
and genetics of ALS.
These clinical trials include:
- A Multi-Center Controlled
Screening Trial of Safety and Efficacy
of Lithium Carbonate in Subjects with Amyotrophic
Lateral Sclerosis (ALS) – The
hypothesis of the study is that lithium
carbonate slows the progressive deterioration
of motor and pulmonary function in patients
with amyotrophic lateral sclerosis (ALS)
by 30%. The total study length is 24 months:
9 months for patient recruitment, 12 months
of intervention (lithium carbonate) and 3
months analysis time. Enrollment
now closed.
- Clinical Trial of IGF-I in Patients with
Amyotrophic Lateral Sclerosis (ALS) – Pre-clinical
trials in cell culture and animal models showed
that IGF-I may promote survival of motor neurons
and may inhibit cell death. An earlier clinical
trial of IGF-1 in patients with ALS was promising,
but inconclusive. This trial was conducted
to determine whether IGF-1 slows the progression
of disease. This trial closed in May 2007.
Results of this study are currently pending
and will be announced after final statistical
and data analysis is completed.
- A Multi-Center, Phase III, Randomized,
Double-Blind Placebo-Controlled, Clinical
Trial of Minocycline in 400 Subjects with
ALS – Minocycline is
a tetracycline antibiotic that has been available
for about 50 years and has been used for the
treatment of bacterial infections, acne and
inflammatory arthritis. Minocycline treatment
in the mouse model of ALS resulted in extended
survival. This study is now closed and results
have been announced. Results showed that
subjects who took Minocycline actually did
worse than patients who took placebo. Thus,
Minocycline will not be a treatment for ALS.
- Combination
Drug Selection Trial in Amyotrophic Lateral
Sclerosis. A Multi-Center, Randomized, Double-Blind,
Phase II Selection trial of Combination Therapy
in 120 Subjects with ALS – The combinations
of minocycline/creatine and celecoxib/creatine
have shown additive effects in the ALS mouse
mode, with each combination extending survival.
This study compared these two combinations
of medications against each other. The object
of this study was to determine whether one
combination was more effective for ALS. This
study is now closed. Results of this
trial showed that the combination of celecoxib/creatine
was non-futile when compared to the placebo
group from another trial. This trial yielded
important information for ways to improve the
design of future trials in ALS.
Current Opportunities to Participate in Research:
- Placebo Controlled Clinical Trial of Dextramethorphan/Quinidine
(07-AVR-123) for Pseudobulbar Affect – Pseudobulbar Affect (PBA) can occur
in people with neurologic disease and causes
sudden, uncontrollable episodes of crying,
laughing or other emotional displays. We
are now participating in a placebo-controlled
clinical trial that investigates the efficacy
and safety of an investigational treatment
known as Zenvia or AVP-923. Subjects will
be randomly assigned to three different arms
of the trial: 1) DM30mg/Q10mg 2) DM20mg/Q10mg
3) placebo for three months. After the initial
three month period every subject with then
be placed on DM30mg/Q10mg for another three
months. Total involvement in this study is
six months. We are currently recruiting.
If you are interested in participating in
this clinical trial call Laura Klenke-Borgmann,
RN at 215-829-5041.
- ALS/FTD Research Project – The
purpose of this research study is to develop
a better understanding of the genetic causes
for both ALS and a form of dementia called
frontotemporal degeneration (FTD). It is hoped
that such information will advance the knowledge
of what causes this condition and in the future
lead to a diagnostic test and treatment for
both ALS and frontotemporal degeneration. The
study involves one blood sample, one urine
sample, possible cerebrospinal fluid sample
(only if clinically indicated), brain MRI and
neuro-cognitive evaluations.
- PEG
study – The purpose of this research
study is to explore the factors/issues that
affect patient/caregivers' decisions
regarding feeding tube placement. The study
involves participants who are considering feeding
tube placement (and their caregivers) to take
a short, paper/pencil surveys before the feeding
tube is placed. If a feeding tube is placed,
the participants will be asked to complete
2 post- feeding tube placement (1 month and
3-6months following the tube placement) surveys.
- Tissue
Donation at the University of Pennsylvania – family
and individuals who are patients of physicians
within the University of Pennsylvania Health
System are eligible to enroll in a program
for autopsy to be performed at the time of
death. In particular, individuals or their
families may choose to donate their brain and
spinal cord to help further research conducted
at the Center of Neurodegenerative Research
in collaboration with the Department of Neurology
at the University of Pennsylvania.
If you are interested in participating in
this program,, please speak to Laura Klenke-Borgmann,
215-829-5041 or contact
the center directly:
The Center for Neurodegenerative Disease Research
University of Pennsylvania School of Medicine
3rd Floor Maloney Building
Philadelphia, PA 19104-4283
Phone: 215-662-4708
Online: www.med.upenn.edu/cndr/
If you are interested in hearing more about
any of the above research opportunities, please
speak to your neurologist at your next office
visit.
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