Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson Disease
Intervention: Botulinum Toxin Type A (Biological); Placebo (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Alberto Espay, MD, Principal Investigator, Affiliation: University of Cincinnati- Neurology
Overall contact:
Ms. Noël Burton, MA, PC, Phone: 513-558-7019, Email: noel.burton@uc.edu
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).
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: 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: 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)
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.
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients must have idiopathic PD (by standard clinical criteria).
2. 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]).
3. Patients must have severity of LID > 1 [mildly disabling] on item 33 of the UPDRS.
4. Patients must have a Mini-Mental State score of > 24.
5. Patients must be willing and able to give consent.
Exclusion Criteria:
1. Patients who are older than 75 years of age.
2. Patients who have a Parkinsonian syndrome that is unresponsive or weakly responsive to
levodopa (improvement < 30%).
3. Patients who require concurrent use of warfarin or other anticoagulating agents.
4. Uncontrolled clinically significant medical condition other than the condition under
evaluation
5. Known allergy or sensitivity to any of the components in the study medication.
6. Concurrent participation in another investigational drug or device study or
participation in the 30 days immediately prior to study enrollment.
7. 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.
8. Evidence of recent alcohol or drug abuse.
9. Infection or skin disorder at an anticipated injection site (if applicable).
10. 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.
Locations and Contacts
Ms. Noël Burton, MA, PC, Phone: 513-558-7019, Email: noel.burton@uc.edu
University Neurology - Movement Disorders Clinic, Cincinnati, Ohio 45219, United States; Recruiting
Additional Information
Starting date: May 2007
Ending date: August 2008
Last updated: April 25, 2008
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