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Official Study Title: A Multi-Center, Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson’s Disease
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on 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. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID: NCT01280123
Study ID: FS03-2010

Summary

This study for people with early Parkinson’s disease (PD) hopes to determine whether pioglitazone, given at 15 and 45 mgs, may slow clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. decline over the course of a 44 week period.  Participants have a two out of three chance of receiving active study medication. A third of the participants will receive a placebo,  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. or inactive pill.  The study is double-blinded, meaning both the participant and investigator will not know whether the participant is receiving the study drug or placebo. Pioglitazone is a Food and Drug Administration-approved drug for the treatment of diabetes.  It has not been studied in people with PD.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Movement and Non-movement

General PD symptoms

Time Commitment

• More than six months
• A minimum of six in-person visits and one telephone visit over a maximum of a year.

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 5
• Study is enrolling non-PD participants

Inclusion Criteria

• Willing and able 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.
• On stable dosage of rasagiline 1 mg/day or selegiline  SelegilineInhibitor that increases the amount of dopamine in the brain to help control the symptoms of Parkinson's in people who are taking levodopa and carbidopa in combination (Sinemet). Selegiline may help people with Parkinson's to decrease the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms. 10 mg/day for at least eight weeks but not more than eight months prior to baseline.  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. Expected to remain on stable dose of rasagiline or selegiline as the only treatment for their PD for the duration of the study (44 weeks).
• Diagnosis must be confirmed by bradykinesia  BradykinesiaSlowness of movement. plus one of the other cardinal signs (resting tremor,  Resting TremorA tremor of a limb that increases when the limb is at rest. 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. being present, without any other known or suspected cause of parkinsonism. The clinical signs must be asymmetric.
• Subjects may be taking stable doses (30 days) of anticholinergics or creatine (< 5gm/day) but must be expected to remain on the same dose.
• Women who are not postmenopausal or surgically sterile must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include  intrauterine devices in place for at least three months; surgical infertility or adequate barrier methods in conjunction with spermicide. Women must have a pregnancy test unless they are at least two years postmenopausal or surgically sterile. Women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating.

Exclusion Criteria

• Exposure to dopaminergic PD therapy  TherapyAnother word for “treatment”. or amantadine within 60 days prior to baseline visit or for 90 days or more at any point in the past.
• Use of any of the following drugs within 180 days prior to baseline: neuroleptics, metoclopramide, alpha-methyldopa, clozapine, olanzapine and flunarizine.
• Use of any of the following drugs within 90 days prior to baseline: methylphenidate, cinnarizine, reserpine, tetrabenazine, amphetamine or monoamine oxidase (MAO-A) inhibitors (pargyline, phenelzine, and tranylcypromine).
• Presence of drug-induced parkinsonism (e.g., metoclopramide, flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other atypical 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. (e.g., 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. multiple system atrophy).
• Participation in other drug studies or receipt of other investigational drugs within 30 days prior to baseline or during the study.
• Presence of freezing.
• Any clinically significant psychiatric or medical condition (e.g., active GI illnesses, angina, active neoplasm).
• History of stereotaxic brain surgery for 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 transplant).
• History of congestive heart failure.
• Use of pioglitazone or rosiglitazone within 90 days before randomization.  RandomizationA method based on chance by which study participants are assigned to a treatment group (arm). Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better.
• Known intolerance to pioglitazone or rosiglitazone.
• Allergy to rasagiline or selegiline, or contraindication to rasagiline or selegiline use.
• Type I or Type II diabetes mellitus.
• Known liver disease.
• Known history of osteoporosis. All women  65 years or older or men and woman at high risk of osteoporosis should have documented evidence of screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. for osteoporosis. Factors associated with high risk of osteoporosis include: previous non traumatic fracture, chronic glucocorticoid use, body weight under 58 kilograms, family history of hip fracture, current cigarette smoking and excessive alcohol intake.
• Drug or alcohol use or dependence.
• Significant peripheral edema – swelling of tissues -- (2+ or more) of the extremities of any etiology.
• Current or planned use of gemfibrozil or rifampin during the trial.
• History of bladder cancer.
• Evidence of hematuria (blood in urine) which has not been evaluated for evidence of bladder cancer.
• History of macular edema.

Enrollment

Expected Enrollment: 216 (US)
Date Enrollment Began: May 2011
Date Enrollment Ends: Jun 2012
Last Updated Date: Nov 02 2011
Trial Post Date: Oct 12 2011
Website: http://clinicaltrials.gov/ct2/show/NCT01280123

Primary Contacts and Locations

New York

• Lisa Stiffler
  lisa.stiffler@chet.rochester.edu
  Phone: (585) 275-3507
  265 Crittenden Blvd CU 420694
  Rochester, NY 14642
  USA
  

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