 The Department of Neurology maintains
its own Clinical Trials Unit on the fifth floor of the
Lakeside Building. The unit is directed by Elisabeth
Welter, MS, MA , who supervises three full time
coordinators. Dr. Gerald Grossman acts as the
Administrative Director of the unit.
The Clinical Trials Unit is presently conducting studies
in a variety of neurologic disorders, including stroke,
epilepsy, Parkinson’s disease, peripheral
neuropathy and late onset Tay-Sachs Disease.
Among the trials presently enrolling patients are included:
Secondary Prevention of
Small Subcortical Strokes
Overview: The purpose of this study is to determine
whether combination antiplatelet therapy consisting of
aspirin plus clopidogrel is superior to aspirin alone
for reducing recurrent stroke (the primary endpoint),
cognitive decline and major vascular events. Another aim
of this study is to determine whether "intensive" blood
pressure lowering to a specific target range is superior
to "usual" hypertension management for reducing
recurrent stroke, cognitive decline and major vascular
events.
Criteria: Participants who had a symptomatic small
subcortical stroke within the prior 6 months, will be
assigned, in a factorial design, to two interventions:
Antiplatelet therapy:
aspirin (325 mg/d, enteric coated) plus placebo vs.
aspirin (325 mg/d, enteric coated) plus clopidogrel (75
mg/day) combination therapy.
Two target levels of
systolic blood pressure control: "usual" (130-149 mmHg)
vs."intensive" (<130 mmHg).
PFO (Patent Foramen Ovale), Stroke
patients
Overview: The Departments of Neurology and Cardiology
are conducting a study to compare Patent Foramen Ovale (PFO)
closure using the AMPLATZER PFO Occluder device to
current standard of care medical treatment in the
prevention of recurrent embolic stroke or transient
ischemic attacks.
Criteria: Participants must be between the ages of 18
and 60 years old with a PFO, and must have had a
cryptogenic stroke defined as follows: acute focal
neurological deficit within the last 90 days presumed
due to focal ischemia, and either 1) persisting over 24
hours; or 2) persisting for less than 24 hours but
associated with MR or CT findings of acute ischemic
stroke.
Insulin Resistance
Intervention after Stroke
Overview: The Department of Neurology is conducting a
research study to find out if pioglitazone, a medication
that is used to treat diabetes, may help prevent another
stroke in patients who have been diagnosed with insulin
resistance and who already suffered a stroke.
Participants will be randomly assigned to receive either
pioglitazone or placebo. This study may or may not
benefit the participant. Participants will be asked to
return to University Hospitals for a clinic visit three
to four times the first year, then once a year for three
years. Parking will be reimbursed but there will be no
other compensation.
Criteria: Participants must be 45 or older, must have
suffered an ischemic stroke within 180 days of
participation and must be insulin resistant.
Participants will have a blood test at the beginning of
the study to determine if they are insulin resistant or
not.
For more information, please contact Elisabeth Welter
at 216-844-5605.
Efficacy and Safety of
SPM927 as Adjunctive Therapy in Subjects With Partial
Seizures
Overview: The purpose of this research study is to
investigate the safety and efficacy of an
investigational drug, SPM927, when used as adjunctive
therapy in patients with partial seizures, with or
without secondary generalization, whose seizures are not
well controlled with their current anti-epileptic drug (AED)
treatment. Participants will be randomized to receive
either one of two doses of SPM927 or placebo; the
investigational drug or placebo will be given in
addition to the AEDs the participants are taking at the
time of trial entry. Participants may or may not benefit
from the study.
The research study is conducted at University
Hospitals of Cleveland. The duration of the research
study is up to 29 weeks, and includes 9 visits; visits
are once a month, except for a 6-week titration phase,
when participants are asked to return for a visit every
two weeks. Participants will be compensated.
Criteria: Participants must be 18 years or older, and
must have a definite diagnosis of simple partial and/or
complex partial seizures, with or without secondary
generalization. They must have had partial onset
seizures for at least two years and must have been
observed to have on average at least 4 partial seizures
per 28 days. In addition, participants must be on a
stable dose of at least one, but no more than 3 AEDs,
with or without vagal nerve stimulation (VNS).
For more information, please contact Dorothy Lemmey
at 216-844-8597.
For other questions, please call:
Elisabeth Welter
University Hospitals
Department of Neurology
Clinical Trials Unit
tel: (216) 844-5605
fax: (216) 844-5613
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