Augmenting Effects of L-DOPS With Carbidopa and Entacapone
Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
An experimental drug called L-DOPS increases production in the body of a messenger chemical
called norepinephrine. Cells in the brain that make norepinephrine are often gone in
Parkinson disease. The exact consequences of this loss are unknown, but they may be related
to symptoms such as fatigue, depression, or decreased attention that occur commonly in
Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa
and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the
effects are of increasing norepinephrine production in the brain and whether carbidopa and
entacapone augment those effects.
Volunteers for this study must be at least 18 years of age and able to give consent to
participate in the study. To participate in the study, volunteers must discontinue use of
alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or
discontinue certain kinds of medications that might interfere with the results of the study.
Candidates will be screened with a medical history and physical exam.
Participants will be admitted to the National Institutes of Health Clinical Center for two
weeks of testing. The study will have three testing phases in a randomly chosen order for
each participant:
- Single dose of L-DOPS
- Single dose of L-DOPS in conjunction with carbidopa
- Single dose of L-DOPS in conjunction with entacapone
Each phase will last two days, with a washout day between each phase in which no drugs will
be given and no testing will be performed. In each phase, participants will undergo a series
of tests and measurements, including blood pressure and electrocardiogram tests. Participants
who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture
(also known as a spinal tap) to obtain spinal fluid for chemical tests.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)