• PDtrials - Parkinson's Disease Clinical Trials
• /Browse All Trials

Official Study Title: An Open-Label,  Open-labelA trial design that allows the researcher and the study participant to know what treatment the participant is receiving. This is the opposite of double-blind study. 12-Month Safety and Efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. Study of Levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. – Carbidopa  CarbidopaDrug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects. Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. and Severe Motor-Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications
Sponsor: Abbott Healthcare Products BV
Clinicaltrials.gov ID: NCT00335153
Study ID: S187.3.004

Summary

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel up to 12 months in people with advanced Parkinson’s disease (PD) and severe motor-fluctuations who have not had optimal response to oral levodopa-carbidopa treatment. Additional supportive evidence for efficacy will be assessed in the treatment of severe motor fluctuations, dyskinesia  DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa. and mobility.

Levodopa-carbidopa intestinal gel is delivered to the upper intestine through a permanent extension tube inserted via percutaneous endoscopic gastrostomy (PEG-J, or a surgical procedure for placing the tube without having to perform an abdominal operation), for long-term treatment.

The delivery of levodopa-carbidopa intestinal gel directly to the upper intestine is anticipated to result in: continuous delivery of levodopa-carbidopa, avoidance of pulsating gastric emptying, and decreased motor fluctuations and dyskinesia.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Balance, Freeze Attacks,  Freeze AttacksThe sudden loss of ability to move. General PD symptoms, Loss of Motor Skills, Muscle Pain, Postural difficulties, Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Speech problems (hypophonic)  HypophonicRelating to hypophonia, or the reduction in the volume and clarity of one's voice. , Tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. Uncontrollable movements (Dyskinesia), Walking/Gait,  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. Writing difficulty

Time Commitment

• More than six months
• Every 2 weeks during 1.5 month, then every month during 3 months and finally every 1.5 months up to end of study

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. PD with the diagnosis made at least 2 years prior to enrollment in the study.
• The participant’s PD must be the levodopa-responsive type as judged by the investigator.
• Participants will need to demonstrate severe motor fluctuations in spite of individually optimized treatment, and where other therapy  TherapyAnother word for “treatment”. options beside oral treatment are indicated.
• Participants must have had optimal treatment with available PD medication and, based upon the judgment of the investigator, are judged inadequately controlled on this optimized treatment.
• Presence of a recognizable “off” and “on” state (motor fluctuations) as confirmed by a diary at baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. (diary measurements will be performed for the three days preceding the baseline visit).
  

Exclusion Criteria

• Diagnosis is unclear or a suspicion of other Parkinsonian syndromes  Parkinsonian SyndromesA group of diseases characterized by symptoms (e.g. tremor, rigidity or stiffness, slow movements and difficulty maintaining balance) common in Parkinson's disease. exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy)  Progressive Supranuclear Palsy, PSPA rare brain disorder diagnosed by the identification of early gait instability and difficulty moving the eyes. PSP is often misdiagnosed because some of its symptoms are very much like those of PD. Although PSP gets progressively worse and there is no effective treatment for it, the disease itself is not directly life-threatening. or other neurodegenerative diseases.
• People who have undergone surgery for the treatment of PD (e.g. pallidotomy, deep brain stimulation,  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. fetal tissue transplantation).
• Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder.
• Psychiatric, neurological or behavioral disorders that may interfere with the person’s ability to give informed consent,  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. or interfere with the conduct or interpretation of the study; troublesome hallucinations would also be included under this category.
• Alzheimer’s disease; or other conditions including significant cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment or dementia.  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality.
• Exposure to any investigational drug  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. within 30 days prior to baseline.
• Prior exposure to levodopa-carbidopa gel.
• People for whom placement of a PEG-J tube for levodopa/carbidopa intestinal gel treatment is contraindicated (inadvisable due to an existing condition), or that the person would be considered a high risk for the PEG-J procedure (placement of the intestinal tube), according to the gastroenterologist’s evaluation. 
  

Enrollment

Expected Enrollment: 250 (International)
Date Enrollment Began: Feb 2008
Date Enrollment Ends: Dec 2010
Last Updated Date: Aug 17 2010
Trial Post Date: Feb 12 2009
Website: http://www.advancedpdstudy.com/?rfr=pdtri

Primary Contacts and Locations

Georgia

• Staci Rokette — Senior Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Program Manager
  Solvay Pharmaceuticals
  staci.rokette@solvay.com
  Phone: (770) 579-7430
  1800 Parkway Place
  Suite 500
  Marietta, GA 30067
  USA
  

Washington

• Alida Griffith — Principal Investigator
  Evergreen Health Care Center
  agriffith@evergreenhealthcare.org
  Phone: (425) 899-3115
  Booth Gardner Parkinson's Care Center
  13030 121st Way NE Ste 203
  Kirkland, WA 98034
  USA
  
• Marsha Merrick — Study Coordinator
  Evergreen Health Care Center
  mgmerrick@evergreenhealthcare.org
  Phone: (425) 899-3115
  Booth Gardner Parkinson's Care Center
  13030 121st Way NE Ste 203
  Kirkland, WA 98034
  USA
  

View All Locations and Contacts