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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00477802
• Other study ID #: 06122801
• Status: Terminated
• Phase: Phase 4
• First received: May 22, 2007
• Last updated: February 13, 2009
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Biological:
• Botulinum Toxin Type A
Injected once during the course of the study.
• Placebo
Injected once during the course of the study.

Locations

Country	Name	City	State
United States	University Neurology - Movement Disorders Clinic	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 and 3 months after injection
Secondary	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)		1 and 3 months after injection