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

NCT00477802 | Terminated Phase 4 DMC

• 1 other identifier: 06122801
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Keywords

Parkinson's disease; levodopa-induced cervical dyskinesias

Outcome Measures

Primary Outcomes (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.

  1 and 3 months after injection

Secondary Outcomes (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)

  1 and 3 months after injection

Study Arms (2)

Botox

EXPERIMENTAL

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

Biological: Botulinum Toxin Type A

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Botulinum Toxin Type A BIOLOGICAL

Injected once during the course of the study.

Botox

Placebo BIOLOGICAL

Injected once during the course of the study.

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Allergan: collaborator

Study Sites (1)

University Neurology - Movement Disorders Clinic

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Alberto Espay, MD

  University of Cincinnati- Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

US (1)