Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03301272
• Date of registration: 13/09/2017
• Prospective Registration: Yes
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease
• Scientific title: Effectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot Study
• Date of first enrolment: March 22, 2018
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03301272
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Daniel A Roque, MD
• Affiliation: University of North Carolina, Chapel Hill

Key inclusion & exclusion criteria

Inclusion Criteria:

1. At least 45 years of age, and no more than 80 years of age.

2. Meet UK Parkinson's disease brain bank diagnostic criteria

3. Have clinical evidence of rest tremor of one or both upper extremities defined as
involuntary, rhythmic oscillations about any joint within the upper extremities

4. Rest tremor amplitude must be at minimum 3 cm as determined by expert opinion by a
movement disorders specialist. Confirmation of amplitude measurement will be obtained
from the Px1 prior to active participation in the study but will not be used for
inclusion/exclusion in study participation.

5. Rest tremor must be historically refractory to at least 2 categories of medications
typically used as anti-parkinsonian agents including levodopa formulations, dopamine
agonists, amantadine, and anticholinergics.

6. Participants must be able to make no changes to their anti-parkinsonian medications
for 150 days (study duration). Ability and safety to do so must also be determined by
the participant's treating physician and confirmed in writing prior to participating.

7. Able to provide informed consent

Exclusion Criteria:

1. History of having undergone botulinum toxin injections for any other condition
previously

2. Allergy to carbidopa or levodopa.

3. Prescreening Montreal Cognitive Assessment (MoCA) score less than 22

4. Prescreening muscle weakness as determined by Medical Research Council grade less than
5/5 on direct testing in the upper limb afflicted with rest tremor.

5. Pregnancy: documentation of non-pregnancy by urine pregnancy test will be obtained
from all women of child-bearing potential prior to participation

6. Infection at the proposed injection site

7. Those with a pre-existing, concomitant neuromuscular disorder

8. Compromised respiratory function

9. History of having undergone deep brain stimulation surgery for any condition



Age minimum: 45 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Onabotulinumtoxin A Injection

Other: Placebo

Primary Outcome(s)

Change in the MDS-UPDRS Tremor Subscore [Time Frame: Prior to onabotulinumtoxinA injection and at 30 days after injection]

Secondary Outcome(s)

Change in Tremor Frequency in Hertz (Hz) as Measured by Px1 [Time Frame: Prior to onabotulinumtoxinA injection and at 30 days after injection]

Change in the ARAT Score [Time Frame: Prior to onabotulinumtoxinA injection and at 30 days after injection]

Change in Tremor Amplitude in Centimeters (cm) as Measured by Px1 [Time Frame: Prior to onabotulinumtoxinA injection and at 30 days after injection]

Correlation Between MDS-UPDRS Tremor Subscore and Px1 Tremor Amplitude [Time Frame: At Visit 1, prior to 1st injection through Visit 4, 30 days after last injection]

Secondary ID(s)

15-1831

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03301272