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

February 13, 2009 updated by: University of Cincinnati

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 and 3 months after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 and 3 months after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Allergan

Investigators

  • Principal Investigator: Alberto Espay, MD, University of Cincinnati- Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (Estimate)

May 24, 2007

Study Record Updates

Last Update Posted (Estimate)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06122801

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.

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