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

NCT ID: NCT00477802

Last Updated: 2009-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Botox

Randomized into receiving Botox first. At cross-over, patients will receive placebo.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: BIOLOGICAL

Injected once during the course of the study.

Placebo

Randomized to receive placebo first. At cross-over, patients will receive the active Botox.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Injected once during the course of the study.

Interventions

Botulinum Toxin Type A

Injected once during the course of the study.

Intervention Type: BIOLOGICAL

Placebo

Injected once during the course of the study.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

University of Cincinnati

Principal Investigators

Alberto Espay, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati- Neurology

Locations

University Neurology - Movement Disorders Clinic

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

06122801

Identifier Type: -

Identifier Source: org_study_id