Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00477802
Recruitment Status : Terminated (Intervention did not appear to be effective in most enrolled patients.)
First Posted : May 24, 2007
Last Update Posted : February 16, 2009
Information provided by:
University of Cincinnati

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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Biological: Botulinum Toxin Type A Biological: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Botox
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 Comparator: Placebo
Randomized to receive placebo first. At cross-over, patients will receive the active Botox.
Biological: Placebo
Injected once during the course of the study.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00477802

Layout table for location information
United States, Ohio
University Neurology - Movement Disorders Clinic
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Layout table for investigator information
Principal Investigator: Alberto Espay, MD University of Cincinnati- Neurology

Layout table for additonal information
Responsible Party: Alberto Espay, MD, University of Cincinnati Identifier: NCT00477802     History of Changes
Other Study ID Numbers: 06122801
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by University of Cincinnati:
Parkinson's disease
levodopa-induced cervical dyskinesias

Additional relevant MeSH terms:
Layout table for MeSH terms
Botulinum Toxins
Botulinum Toxins, Type A
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents