Impact of Switching to Continuous Release Dopamine Agonists

This is an interventional treatment trial for Parkinson Disease Read More

Inclusion Criteria:

Each subject must meet all of the following inclusion criteria to qualify for entrance into the study:

• Subjects who are male or female and are aged 55 and older.
• Subjects and/or their legal guardians must be able and willing to give informed consent.
• Subjects must be on stable doses of pramipexole for greater than 4 weeks duration prior to screening.
• Subjects who are female must be non-pregnant and non-nursing. Women of Child-Bearing Potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum pregnancy test at screening. Women are considered to not be of child-bearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation) or if they are post-menopausal.
• Subjects must have a clinical diagnosis of Parkinson's based on the presence of at least 2 of the 3 cardinal criteria - rest tremor, bradykinesia, rigidity - and no obvious history of head trauma, stroke, infectious, structural, or metabolic abnormality consistent with an alternative diagnosis to Parkinson's disease.
• Evidence of one or more of the following symptoms: somnolence (ESS score ≥ 9), cognitive decline (MMSE < 24 ± presence of hallucinations (NPI-Q), peripheral edema (present by objective physical exam with baseline ankle and calf circumference measured in centimeters).

Exclusion Criteria:

A subject who meets any of the following criteria will NOT qualify for the study:

• Subjects must not be receiving any treatments for excess somnolence such as amphetamine derivatives, other stimulants or Provigil.
• Subjects with actively treated malignancies, clinically significant heart disease, kidney, liver, or pulmonary disorders will be excluded.
• Subjects with clinical depression who are not receiving stable doses of antidepressant therapy in excess of 4 weeks duration.
• Subjects with history of orthostatic hypotension (>30mm drop in systolic pressure and/or >20mm drop in diastolic pressure) associated with syncope.
• Subjects started within the last 14 days on any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, fluvoxamine) or induce CYP1A2 (e.g.omeprazole) (Note: Subjects already on these agents may be enrolled but must remain on the stable doses of the agents from 14 days prior to the beginning of the study).
• Subjects who have other medical conditions that are considered clinically unstable or that may compromise the safety of the patient during this study.