Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 October 2017 |
Main ID: |
NCT02419313 |
Date of registration:
|
27/01/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach
|
Scientific title:
|
Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized Approach |
Date of first enrolment:
|
August 2012 |
Target sample size:
|
33 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02419313 |
Study type:
|
Interventional |
Study design:
|
|
Phase:
|
Phase 2
|
|
Countries of recruitment
|
United States
| | | | | | | |
Contacts
|
Name:
|
Bahman Jabbari, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Yale University |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria.
1. Age more than 18 years
2. Both sexes
3. all races/ethnic groups.
4. Meeting the clinical diagnosis of Parkinson's disease with presence of moderate to
severe Parkinson tremor that is refractory to standard medical treatments and which
limits the patient?s functionality and/or poses significant discomfort.
5. Subjects who are able to read, speak, and understand English.
Exclusion Criteria.
1. Existing significant acute medical condition (i.e. cardiovascular, endocrine,
hematologic, neoplastic, infectious, or autoimmune disorders) or significant
swallowing or breathing difficulties.
2. Pregnancy or planned pregnancy (determined by urine pregnancy test).
3. Active breast feeding.
4. Enrollment in any clinical trial (currently or within the past 3 months) in which
treatments are imposed by a protocol.
5. Any subject for whom botulinum toxin treatment would be contraindicated; known allergy
or sensitivity to medication.
6. Subjects who are younger than 18 years of age. Neuromuscular-junction disorders.
7. Evidence of acute pathology in neuro-imaging.
8. Axis I diagnosis determined by a neurologist or psychiatrist.
9. Use of Anesthetic medications within two weeks and corticosteroid injections within 4
weeks of enrollment.
10. Those who received botulinum toxin injections in the past 4 months.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Tremor
|
Parkinson
|
Intervention(s)
|
Drug: incobotulinumtoxinA
|
Drug: Saline
|
Primary Outcome(s)
|
Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale
[Time Frame: 4 weeks]
|
Secondary Outcome(s)
|
Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale
[Time Frame: 4 Weeks]
|
Number of Patients Whose Patient Global Impression of Change (PGIC) Improved
[Time Frame: 4 weeks]
|
Secondary ID(s)
|
1206010370
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|