A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
Completed · Phase 1
Conditions studied: Parkinson Disease
In brief
This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease.
Key facts
- Study ID
- NCT03496870
- Run by
- Neurocrine Biosciences
- People needed
- 16
- Starts
- 2018-02-08
- Expected to finish
- 2018-07-02
- Last updated by the study team
- 2019-03-22
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment
- Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD
- Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
- Have a body mass index (BMI) of 18 to 40 kg/m2
- Have a modified Hoehn and Yahr stage of ≤4 in the OFF state
- Be able to tolerate an overnight period of 12 hours without CD/LD
- Be in good general health and expected to complete the clinical study as designed
You may not qualify if…
- Are currently pregnant or breastfeeding
- More than 2 alcoholic beverages daily or more than 14 alcoholic beverages weekly within 7 days of Day -1 or consume any alcohol within 48 hours of Day -1.
- Have motor fluctuations during the day (ie, effect of levodopa "wearing off" or having unpredictable "off" periods), or severe or intolerable levodopa-induced dyskinesia
- Have had previous exposure to opicapone, or have an allergy, hypersensitivity, or intolerance to opicapone or other COMT inhibitor.
- Have a history of a medical condition or surgical procedure that might interfere with absorption or metabolism.
- Have a known history of neuroleptic malignant syndrome
- Have an unstable medical condition or chronic disease
- Have taken certain prohibited medications within 28 days of Day -1.
- Have a known or suspected diagnosis of AIDS, or have tested seropositive for HIV
- Have hepatitis A or B
- Have a significant risk of suicidal or violent behavior
Where it is running
- Neurocrine Clinical Site — Glendale, California, United States
- Neurocrine Clinical Site — Long Beach, California, United States
- Neurocrine Clinical Site — Farmington Hills, Michigan, United States
Full record on ClinicalTrials.gov
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