- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004670
Phase II Study of Pallidotomy for Parkinson Disease
OBJECTIVES:
I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative assessments vs. delayed pallidotomy following 6 months of standard medical therapy in patients with Parkinson disease.
Study Overview
Detailed Description
PROTOCOL OUTLINE: This is a randomized study. One group of patients undergoes the surgical procedure pallidotomy, a precise lesioning of brain cells in the globus pallidus.
The other group receives standard medical care for 6 months followed by a pallidotomy.
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Idiopathic Parkinson disease Hoehn and Yahr stage III or worse during "off" periods
Responsive to levodopa by history or exam Sub-optimal clinical response to maximal medication Medication optimized for at least 4 weeks prior to entry
No atypical or secondary disease, e.g.:
- No history of cerebrovascular accident
- No cerebellar involvement
- No severe brain atrophy on magnetic resonance imaging
No Mattis Dementia Rating Scale score less than 116
No dementia meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria
No Hamilton Depression Rating Scale score greater than 10
No Hamilton Anxiety Scale score greater than 14
--Patient Characteristics--
Other: No medical contraindication to surgery, e.g.:
- Diabetes
- Cardiopulmonary disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Mahlon R. DeLong, Emory University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/12083
- EUSM-018
- EUSM-409-92
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on pallidotomy
-
InSightecActive, not recruitingParkinson DiseaseUnited States, Canada, United Kingdom, Korea, Republic of, Spain, Israel, Italy, Taiwan
-
All India Institute of Medical Sciences, New DelhiNot yet recruiting
-
Children's National Research InstituteRecruitingCerebral Palsy, Dyskinetic | Secondary DystoniaUnited States
-
InSightecRecruitingMovement Disorders | Parkinsons Disease | NeurologyUnited States, Japan
-
Yonsei UniversityCompletedLevodopa Induced Dyskinesia in Patients With Parkinson's DiseaseKorea, Republic of
-
Peking University People's HospitalActive, not recruitingBlepharospasm | Meige Syndrome | Meigs Syndrome | Meige Disease | Meig Syndrome | Blepharospasm of Left Eyelid | Blepharospasm of Right Eyelid | Blepharospasm of Both Eyelids | Blepharospasm Oromandibular DystoniaChina