Impact of Switching to Continuous Release Dopamine Agonists - Full Text View

Sponsor:	University of Toledo Health Science Campus
Information provided by:	University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:	NCT00465452

Purpose

The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.

Condition	Intervention	Phase
Parkinson Disease	Drug: Continuous Release Dopamine Agonists	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Edema Parkinson's Disease

Drug Information available for: Dopamine Dopamine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:

Equal or improved motor scores as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), parts 3 (motor performance) and 4 (disability). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ] [ Designated as safety issue: No ]
A significant improvement in somnolence as measured by the Epworth Sleepiness Scale (ESS). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ] [ Designated as safety issue: No ]
A significant stabilization or improvement in the cognitive/mood battery of the Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9) and the Neuropsychiatric Inventory Questionnaire (NPI-Q). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ] [ Designated as safety issue: No ]
An improvement in peripheral edema, as measured by quantitative assessment of ankle and calf edema. [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ] [ Designated as safety issue: No ]
Increased patient satisfaction/preference (Patient Satisfaction Questionnaire - PS) scores. [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ] [ Designated as safety issue: No ]
Improvement in quality of life (Parkinson's Disease Questionnaire - PDQ-39). [ Time Frame: initial visit and repeated at 4, 12, and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Continuous Release Dopamine Agonists

Detailed Description:

The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by these patients. Side effects that we will monitor in particular include somnolence, peripheral edema, cognitive decline with and without hallucinations. PD patients followed in the MUO Neurology Clinic who are being treated with pramipexole and have evidence of at least one of the following symptoms: somnolence, cognitive impairment with or without hallucinations, or peripheral edema will be offered the opportunity to participate in this study.

Fifteen subjects who are currently receiving pramipexole therapy (monotherapy or adjunctive therapy) who are experiencing one or more of the following symptoms: somnolence, cognitive decline with/without hallucinations, and peripheral edema will be asked if they are willing to participate at the time of their clinic visit at the PDMDP.

The crossover from pramipexole to ropinirole CR will be performed over a 2 week interval. During the first week, the initial drug dose will substitute ½ of the pramipexole with ½ of the target dose of ropinirole CR. If subjects are tolerating the drug change, then 100% of the target dose of ropinirole CR (and no pramipexole) will be started in the second week.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465452

Locations

United States, Ohio
Medical University of Ohio
Toledo, Ohio, United States, 43614

Sponsors and Collaborators

University of Toledo Health Science Campus

Investigators

Principal Investigator:

Lawrence Elmer, MD, PhD

Medical University of Ohio

More Information

No publications provided

Responsible Party:	Lawrence Elmer, MD, PhD, University of Toledo, Health Science Campus
ClinicalTrials.gov Identifier:	NCT00465452 History of Changes
Other Study ID Numbers:	MUO-04
Study First Received:	April 24, 2007
Last Updated:	March 18, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Dopamine Agonists

Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012