Back to resultsBotulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, levodopa-induced cervical dyskinesias
Eligibility Criteria
Inclusion Criteria:
- Patients must have idiopathic PD (by standard clinical criteria).
- Patients must have persistence of LID despite optimization of anti-Parkinsonian medication (duration of LID > 1 [duration of at least 1-25% of the waking time] on item 32 of the United Parkinson's Disease Rating Scale [UPDRS]).
- Patients must have severity of LID > 1 [mildly disabling] on item 33 of the UPDRS.
- Patients must have a Mini-Mental State score of > 24.
- Patients must be willing and able to give consent.
Exclusion Criteria:
- Patients who are older than 75 years of age.
- Patients who have a Parkinsonian syndrome that is unresponsive or weakly responsive to levodopa (improvement < 30%).
- Patients who require concurrent use of warfarin or other anticoagulating agents.
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Known allergy or sensitivity to any of the components in the study medication.
- Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
- Any medical condition that may put the subject at an increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
- Evidence of recent alcohol or drug abuse.
- Infection or skin disorder at an anticipated injection site (if applicable).
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Sites / Locations
- University Neurology - Movement Disorders Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botox
Placebo
Arm Description
Randomized into receiving Botox first. At cross-over, patients will receive placebo.
Randomized to receive placebo first. At cross-over, patients will receive the active Botox.
Outcomes
Primary Outcome Measures
the change in the "on" time with LID 1 month and 3 months after injected compared to baseline scores. A reduction of 40% in the mean "on" time with LID in the Botox® group compared to the placebo group will be considered significant.
Secondary Outcome Measures
changes in: the duration, severity, and pain of LID using the UPDRS Part IV, physician and patient Clinical Global Impression [CGI] of change, Schwab & England score, Abnormal Involuntary Movement Scale, 4-point modified dyskinesia rating scale (Goetz)
Full Information
NCT ID
NCT00477802
First Posted
May 22, 2007
Last Updated
February 13, 2009
Sponsor
University of Cincinnati
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00477802
Brief Title
Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease
Official Title
Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease: A Double-Blind, Randomized, Placebo Controlled, Cross-Over Design Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
Intervention did not appear to be effective in most enrolled patients.
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to determine whether intramuscular injections of botulinum toxin type A (Botox®) in selected cervical muscles at antidystonic dosages can reduce levodopa-induced peak-dose dyskinesias (LID) in the cervical region in adult patients with idiopathic Parkinson's disease. It is hypothesized that the intramuscular injection of antidystonic doses of botulinum toxin into cervical muscles will decrease the duration and severity of LID in the cervical region in patients with Parkinson's disease (PD).
Detailed Description
The study will follow a cross-over design to maximize statistical power and decrease biases inherent to small samples as patients will become their own controls. After a baseline assessment, patients will be randomized to receive either botulinum toxin or an equal amount and distribution of normal saline (placebo). Patients will undergo reassessment of function at one and four weeks after the initial and second session of injections. The second procedure will occur, using the opposite treatment arm (Botox® or saline placebo), three months after the first injection session. Doses of levodopa, dopaminergic agonists, and antidyskinetic drugs if applicable, will be kept constant throughout the study. All study assessments will be carried out at the time treatment is expected to cause the greatest severity of LID.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, levodopa-induced cervical dyskinesias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botox
Arm Type
Experimental
Arm Description
Randomized into receiving Botox first. At cross-over, patients will receive placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized to receive placebo first. At cross-over, patients will receive the active Botox.
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A
Intervention Description
Injected once during the course of the study.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Injected once during the course of the study.
Primary Outcome Measure Information:
Title
the change in the "on" time with LID 1 month and 3 months after injected compared to baseline scores. A reduction of 40% in the mean "on" time with LID in the Botox® group compared to the placebo group will be considered significant.
Time Frame
1 and 3 months after injection
Secondary Outcome Measure Information:
Title
changes in: the duration, severity, and pain of LID using the UPDRS Part IV, physician and patient Clinical Global Impression [CGI] of change, Schwab & England score, Abnormal Involuntary Movement Scale, 4-point modified dyskinesia rating scale (Goetz)
Time Frame
1 and 3 months after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have idiopathic PD (by standard clinical criteria).
Patients must have persistence of LID despite optimization of anti-Parkinsonian medication (duration of LID > 1 [duration of at least 1-25% of the waking time] on item 32 of the United Parkinson's Disease Rating Scale [UPDRS]).
Patients must have severity of LID > 1 [mildly disabling] on item 33 of the UPDRS.
Patients must have a Mini-Mental State score of > 24.
Patients must be willing and able to give consent.
Exclusion Criteria:
Patients who are older than 75 years of age.
Patients who have a Parkinsonian syndrome that is unresponsive or weakly responsive to levodopa (improvement < 30%).
Patients who require concurrent use of warfarin or other anticoagulating agents.
Uncontrolled clinically significant medical condition other than the condition under evaluation
Known allergy or sensitivity to any of the components in the study medication.
Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
Any medical condition that may put the subject at an increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
Evidence of recent alcohol or drug abuse.
Infection or skin disorder at an anticipated injection site (if applicable).
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Espay, MD
Organizational Affiliation
University of Cincinnati- Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Neurology - Movement Disorders Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease
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