Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease - Full Text View

Sponsor:	University of Cincinnati
Collaborator:	Allergan
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00477802

Purpose

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).

Condition	Intervention	Phase
Parkinson Disease	Biological: Botulinum Toxin Type A Biological: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Botox Parkinson's Disease

Drug Information available for: Levodopa Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

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. [ Time Frame: 1 and 3 months after injection ] [ Designated as safety issue: No ]

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) [ Time Frame: 1 and 3 months after injection ] [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	May 2007
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Botox: Experimental Randomized into receiving Botox first. At cross-over, patients will receive placebo.	Biological: Botulinum Toxin Type A Injected once during the course of the study.
Placebo: Placebo Comparator Randomized to receive placebo first. At cross-over, patients will receive the active Botox.	Biological: Placebo Injected once during the course of the study.

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

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477802

Locations

United States, Ohio
University Neurology - Movement Disorders Clinic
Cincinnati, Ohio, United States, 45219

Sponsors and Collaborators

University of Cincinnati

Allergan

Investigators

Principal Investigator:

Alberto Espay, MD

University of Cincinnati- Neurology

More Information

No publications provided

Responsible Party:	University of Cincinnati ( Alberto Espay, MD )
Study ID Numbers:	06122801
Study First Received:	May 22, 2007
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00477802 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

Parkinson's disease
levodopa-induced cervical dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Basal Ganglia Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Neuromuscular Agents
Neurodegenerative Diseases
Brain Diseases
Signs and Symptoms
Movement Disorders
Therapeutic Uses
Botulinum Toxin Type A

Levodopa
Nervous System Diseases
Central Nervous System Diseases
Dyskinesias
Pharmacologic Actions
Botulinum Toxins
Parkinson Disease
Neurologic Manifestations
Dopamine Agents
Parkinsonian Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010