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“I participate because it is the right thing to do, for myself, for my children, and for the millions of people who have Parkinson’s disease.  Without participation there will be no cure.” –Mike, Diagnosed 7 years

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Recently Diagnosed with Parkinson's Disease?

If you have recently been diagnosed with Parkinson’s disease (PD) understanding the disease, and learning about the resources available to you, are good first steps.

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Safety and Efficacy Study of Levodopa–Carbidopa Intestinal Gel in Levodopa-Responsive Participants with Advanced Parkinson's and Severe Motor Fluctuations - Still Enrolling!

Official Study Title: 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. 6-12 Months 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
Sponsor: Solvay Pharmaceuticals B.V.
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 over six 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
  • Minimum Years Since Diagnosis: 2

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: Mar 2010
Last Updated Date: Feb 25 2010
Trial Post Date: Feb 12 2009
Website: http://www.clinicaltrials.gov/ct2/show/NCT00335153

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 — Primary 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

Local Contacts and Locations

Alabama

  • David Standaert
    University of Alabama at Birmingham
    Phone: (205) 996-4030
    Department of Neurology
    1720 7th Avenue South
    Birmhingham, AL 35222
    USA

California

  • Mark Lew
    University of Southern California
    mlew@surgery.usc.edu
    Phone: (323) 442-5791
    Division of Movement Disorder, Department of Neurology
    1520 San Pablo Street
    Los Angeles, CA 90033
    USA
  • Karen Frei
    Parkinson's & Movement Disorder Institute
    drkfrei@yahoo.com
    Phone: (714) 378-5062
    9940 Talbert Ave
    Suite 204
    Fountain Valley, CA 92708
    USA
  • Neil Hermanowicz — Study Coordinator
    University of California Medical Center Irvine Medical Center
    Phone: (949) 824-8116
    Department of Neurology
    100 Irvine Hall
    Irvine, CA 92697
    USA
  • Shari Niswonger — Irvine Medical Center
    University of California Medical Center
    slniswon@uci.edu
    Phone: (949) 824-8116
    Department of Neurology
    100 Irvine Hall
    Irvine, CA 92697
    USA
  • Lupe Sanchez, C.C.R.C.
    Neurology  NeurologyThe scientific study of the nervous system, especially in respect to its structure, functions, and abnormalities. Center
    lsanchez@neurocenter.com
    Phone: (760) 732-0557, EXT. #147
    3907 Waring Road
    Suite #3
    Oceanside, CA 92056
    USA
  • Michael Lobatz
    Neurology Center
    Phone: (760) 732-0577, EXT. # 143
    3907 Waring Road
    Suite #3
    Oceanside, CA 92056
    USA

Colorado

  • Rajeev Kumar
    Colorado Neurological Institute
    Phone: (303) 783-4974
    701 East Hampden Avenue
    Suite 510
    Englewood, CO 80113
    USA

District Of Columbia

  • Denise Barlett, R.N. — Study Coordinator
    Georgetown University Hospital
    bartletd@georgetown.edu
    Phone: (202) 444-2658
    Department of Neurology - Movement Disorders
    3800 Reservoir Road West, #7PHC
    Washington, DC 20007
    USA
  • Fernando Pagan
    Georgetown University Hospital
    Phone: (202) 444-1382
    Department of Neurology - Movement Disorders
    3800 Reservoir Road West, #7PHC
    Washington, DC 20007
    USA

Florida

  • Robert Hauser
    University Of South Florida Medical Center
    hdelgado@hsc.usf.edu
    Phone: (813) 844-4453
    5 Tampa General Circle
    Suite 410
    Tampa, FL 33606
    USA
  • Hubert Fernandez
    University of Florida
    fernandez@neurology.ufl.edu
    Phone: (212) 273-8408
    Department of Neurology, PO Box 100236
    100 S. Newell Drive, Rm L3-100
    Gainesville, FL 32610
    USA
  • Zhigao Huang
    University of Florida
    Phone: (904) 244-9480
    Department of Neurology, 580 West 8th Street
    9th Floor Tower A
    Jacksonville, FL 32209
    USA
  • Carol Swink, C.R.C. — Study Coordinator
    Charlotte Neurological Services
    cswink@daystar.net
    Phone: (941) 743-4987
    4235 Kings Highway
    Suite #102
    Port Charlotte, FL 33890
    USA
  • Ramon Gil — Study Coordinator
    Charlotte Neurological Services
    Phone: (941) 743-4987
    4235 Kings Highway
    Suite #102
    Port Charlotte, FL 33890
    USA
  • Jonathan Harris
    Neurologic Consultants, PA
    brainville@incresearch.com
    Phone: (954) 776-9111
    1841 NE 45th Street
    Ft. Lauderdale, FL 33308
    USA
  • Laurie Emmert, L.P.N. — Study Coordinator
    Bradenton Research Center, Inc.
    laurieemmert@bradentonresearch.com
    Phone: (941)708-0005
    Dr. McElveen's Office
    3924 9th Avenue West
    Brandenton, FL 34205
    USA
  • William McElveen
    Bradenton Research Center, Inc.
    bradenton_neurology@hotmail.com
    Phone: (941) 708-0005
    Dr. McElveen's Office
    3924 9th Avenue West
    Brandenton, FL 34205
    USA

Georgia

  • Kapil Sethi
    Medical College of Georgia
    jgleba@neuro.mcg.edu
    Phone: (706) 721-2798
    Department of Neurology
    1429 Harper Street, HF1121
    Augusta, GA 30912
    USA

Illinois

  • Cindy Zadikoff
    Northwestern Medical Faculty Foundation
    czadikof@nmff.org
    Phone: (312) 695-7950
    710 N. Lake Shore Dr.
    Abbott Hall, 11th Floor
    Chicago, IL 60611
    USA
  • Jean Jaglin, R.N., C.C.R.C. — Study Coordinator
    Rush University Medical Center
    jean_a_jaglin@rush.edu
    Phone: (312) 563-2900
    1725 West Harrison Street
    Suite #809
    Chicago, IL 60612
    USA
  • Leonard Verhagen
    Rush University Medical Center
    Phone: (312) 942-5157
    1725 West Harrison Street
    Suite #809
    Chicago, IL 60612
    USA

Kentucky

  • John Slevin
    University of Kentucky
    Phone: (859) 323-6702
    Department of Neurology, 740 S. Limestone Street
    L 445 Kentucky Clinic
    Lexington, KY 40536
    USA

Louisiana

  • LaBrilla Johnson, R.N. — Clinical Coordinator
    Louisiana State University Health Sciences Center
    ljoh23@lsuhsc.edu
    Phone: (318) 675-8157
    Department of Movement Disorders
    1501 Kings Highway Room 3-428
    Shreveport, LA 71103
    USA
  • Richard Zweig, M.D.
    Louisiana State University Health Sciences Center
    Phone: (318) 675-5683
    Department of Movement Disorders
    1501 Kings Highway Room 3-428
    Shreveport, LA 71103
    USA

Maryland

  • Bradley Robottom
    University of Maryland School of Medicine
    nzappala@som.umaryland.edu
    Phone: (410) 328-2164
    Office of Dr. Shulman
    110 South Paca Street Room #3-S-127
    Baltimore, MD 21201
    USA
  • Michelle Cines, R.N. — Study Coordinator
    University of Maryland School of Medicine
    mcines@som.maryland.edu
    Phone: (410) 328-7112
    Office of Dr. Shulman
    110 South Paca Street Room #3-S-127
    Baltimore, MD 21201
    USA
  • Nancy Zappala, R.N. — Study Coordinator
    University of Maryland School of Medicine
    nzappala@som.maryland.edu
    Phone: (410) 328-7112
    Office of Dr. Shulman
    110 South Paca Street Room #3-S-127
    Baltimore, MD 21201
    USA
  • Joseph Savitt — Study Coordinator
    Johns Hopkins University
    Phone: (410) 614-0577
    Department of Neurology - Movement Disorders
    600 North Wolfe Street Meyer 6-119
    Baltimore, MD 21287
    USA
  • Melissa Gerstenhaber, R.N.C., M.S.N. — Study Coordinator
    Johns Hopkins University
    mgerste1@jhmi.edu
    Phone: (410) 614-1242
    Department of Neurology - Movement Disorders
    600 North Wolfe Street Meyer 6-119
    Baltimore, MD 21287
    USA

Missouri

  • Brad Racette — Study Coordinator
    Washington University School of Medicine
    Phone: (314) 362-8548
    Movement Disorders Center
    660 S. Euclid Avenue Campus Box 8111
    St. Loius, MO 63110
    USA
  • Kathy Wharton, R.N. — Study Coordinator
    Washington University School of Medicine
    whartonk@neuro.wustl.edu
    Phone: (314) 362-2059
    Movement Disorders Center
    660 S. Euclid Avenue Campus Box 8111
    St. Loius, MO 63110
    USA
  • Mary Creech, R.N., M.S.W., L.C.S.W. — Study Coordinator
    Washington University School of Medicine
    maryc@npg.wustl.edu
    Phone: (314) 362-7651
    Movement Disorders Center
    660 S. Euclid Avenue Campus Box 8111
    St. Loius, MO 63110
    USA

North Carolina

  • Mustafa Siddiqui
    Wake Forest University School of Medicine
    Phone: (336) 716-1619
    Medical Center Blvd
    Winston Salem, NC 27157
    USA
  • Keith Hull, Jr., M.D.
    Raleigh Neurology Associates, P.A.
    Phone: (919) 420-1659
    Office of Dr. Hull
    1540 Sunday Drive
    Raleigh, NC 27607
    USA
  • Mary Allen, R.N. — Study Coordinator
    Raleigh Neurology Associates, P.A.
    mallen@raleighneurology.com
    Phone: (919) 782-3456, EXT. #8265
    Office of Dr. Hull
    1540 Sunday Drive
    Raleigh, NC 27607
    USA
  • Sanjay Iyer, M.D.
    Carolinas Medical Center
    Phone: (704) 446-1909
    Neuroscience and Spine Institute
    1010 Edgehill Road North
    Charlotte, NC 28207
    USA
  • Joanne Nemeth, R.N., B.S.N. — Study Coordinator
    Carolinas Medical Center
    joanne.nemeth@carolinashealthcare.org
    Phone: (704) 446-0803
    Neuroscience and Spine Institute
    1010 Edgehill Road North
    Charlotte, NC 28207
    USA
  • Jacqueline Foster — Study Coordinator
    Carolinas Medical Center
    jacqueline.foster@carolinashealthcare.org
    Phone: (704) 446-1909
    Neuroscience and Spine Institute
    1010 Edgehill Road North
    Charlotte, NC 28207
    USA

Nebraska

  • John Bertoni
    Creighton Neurology
    jbertoni@unmc.edu
    Phone: (402) 559-8932
    2045 Nebraska Medical Center
    Omaha, NE 68198
    USA

Nevada

  • Jean Ayan, R.N. — Study Coordinator
    North Shore - Long Island Jewish Feinstein Institute
    jayan@nshs.edu
    Phone: (516) 562-2426
    Neurology - Dr. Pourfar
    350 Community Drive
    Manhasset, NV 11030
    USA
  • Michael Pourfar, M.D. — Primary Investigator
    North Shore-LIJ Feinstein Institute
    Phone: (516) 562-2426
    Neurology - Dr. Pourfar
    350 Community Drive
    Manhasset, NV 11030
    USA

New York

  • Cheryl Waters
    Neurological Institute of NY
    Phone: (212) 305-3665
    710 West 168th St
    NI-3
    New York, NY 10032
    USA
  • Joan Bratton — Study Coordinator
    Mount Sinai Medical Center
    joan.bratton@mssm.edu
    Phone: (212) 659-5643
    Movement Disorder Center One Gustave Levy Place
    5 East 98th Street 1st Floor, Box #1139
    New York, NY 10029
    USA
  • Michele Tagliati — Study Coordinator
    Mount Sinai Medical Center
    Phone: (516) 470-6974
    Movement Disorder Center One Gustave Levy Place
    5 East 98th Street 1st Floor, Box #1139
    New York, NY 10029
    USA

Ohio

  • Ilia Itin
    Cleveland Clinic
    Phone: (216) 445-3862
    9500 Euclid Avenue
    Cleveland, OH 44106
    USA
  • Alberto Espay
    University Neurology, Inc.
    Phone: (513) 558-4035
    222 Piedmont Ave, Ste 3200
    Cincinnati, OH 45219
    USA

Pennsylvania

  • Gabriel Tatarian — Study Coordinator
    Thomas Jefferson University Hospitals
    Phone: (215) 955-8700
    Parkinson's Disease Research Unit
    1015 Chestnut Street Suite #520
    Philadelphia, PA 19107
    USA
  • Stephanie Sendak — Study Coordinator
    Thomas Jefferson University Hospitals
    stephanie.sendek@jefferson.edu
    Phone: (215) 955-8700
    Parkinson's Disease Research Unit
    1015 Chestnut Street Suite #520
    Philadelphia, PA 19107
    USA

Vermont

  • James Boyd
    Fletcher Allen Health Care/University of Vermont
    Phone: (802) 847-4589
    1 South Prospect St, 4th Floor
    Burlington, VT 05401
    USA

Wisconsin

  • Clara Schindler — Study Coordinator
    Medical College of Wisconsin
    cschindler@mcw.edu
    Phone: (414) 805-3260
    Department of Neurology
    9200 West Wisconsin Avenue
    Milwaukee, WI 53226
    USA
  • Department of Neurology
    9200 West Wisconsin Avenue
    Milwaukee, WI 53226
    USA
  • Serena Hung, M.D.
    Medical College of Wisconsin
    Phone: (414) 805-9719
    Department of Neurology
    9200 West Wisconsin Avenue
    Milwaukee, WI 53226
    USA

View All Locations and Contacts