Keppra for Cervical Dystonia (Keppra)
Primary Purpose
Cervical Dystonia
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Keppra
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia focused on measuring cervical dystonia, keppra, botox, spasmodic torticollis
Eligibility Criteria
Inclusion Criteria:
- Patients will have received their last Botox injections 12-16 weeks ago
- Any oral medications for cervical dystonia will be stable for 4 weeks and will continue throughout the study
Exclusion Criteria:
- Less than 21 years old
- Received Botox more than 16 weeks ago
- Not on a stable dose of oral medications for cervical dystonia
Sites / Locations
Outcomes
Primary Outcome Measures
Primary endpoint will be the difference in change in TWSTRS score from baseline to week 16.
Secondary Outcome Measures
Secondary outcome measures will include difference in change in TWSTRS score from baseline to weeks 4, 8, 12, 16, 20, and 24 in patient-reported duration of benefit for their Botox injection, and length of time between injections.
Full Information
NCT ID
NCT00760318
First Posted
September 24, 2008
Last Updated
November 21, 2018
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT00760318
Brief Title
Keppra for Cervical Dystonia
Acronym
Keppra
Official Title
Prospective Double Blind Evaluation of Levetiracetam (Keppra) for the Treatment of Cervical Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decided to stop enrollment to review data.
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate if there is an improved response in CD symptoms when Keppra is used as adjunctive therapy to Botox.
Detailed Description
Up to 40 patients with cervical dystonia and receiving intermittent Botox injections will be enrolled in the study. Patients will be evaluated at baseline 12-16 weeks following their prior set of Botox injections. Patients will be evaluated using the TWSTRS Cervical Dystonia Scale. Any oral medications for the treatment of cervical dystonia will be stable for at least four weeks and will continue unchanged throughout the study. Following Baseline evaluation, subjects will undergo their standard set of Botox injections. This will consist of the same dose and approximate placement as their prior set of injections. Subjects will then be randomized to LEV or placebo. They will begin oral study medication beginning with an LEV dose of 250 mg each evening or placebo. There will be flexible dose titration increasing by 250 mg per week for 12 weeks to a maximum of 3000 mg divided BID. The subjects will be on a stable dose of medication for weeks 12 to 16 (or to week 20 in subjects with sufficient improvement that they do not require Botox injections). Subjects will be evaluated at weeks 4,8,12, 16, 20 and 24. The primary efficacy outcome measure will be the difference in change in TWSTRS score from baseline to week 16. Patients may undergo Botox injections prior to the week 16 visit if it is medically necessary or if the subject indicates that they are experiencing intolerable discomfort. In these cases, final evaluation will be performed prior to Botox injection and their scores will be carried forward to endpoint. Those subjects who have sufficient improvement such that they don't require Botox injections at or by week 16 will be monitored on study medication for an additional four weeks. Following Botox injection or 20 weeks, subjects will undergo a two-week off titration of study medication. Secondary outcome measures will include difference in change in TWSTRS score from baseline to weeks 4, 8, 12, 16, 20 and 24 in patient-reported pain scale, Clinical Global Impression scale, Clinical Patient Improvement scale, patient reported disability scale, and length of time between injections. Adverse events will be recorded and described. Serious Adverse events will be reported to the FDA in writing within 15 calendar days of knowledge of the event with a copy sent to UCB and the USF Internal Review Board.
A comparison across groups of the number of subjects who require injections prior to week 16 will be undertaken. In addition, a comparison across groups of the number of subjects not requiring injections at week 16 will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
Keywords
cervical dystonia, keppra, botox, spasmodic torticollis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Keppra
Other Intervention Name(s)
levetiracetam
Intervention Description
There will be flexible dose titration increasing by 250 mg per week for 12 weeks to a maximum of 3000 mg divided BID.
Primary Outcome Measure Information:
Title
Primary endpoint will be the difference in change in TWSTRS score from baseline to week 16.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Secondary outcome measures will include difference in change in TWSTRS score from baseline to weeks 4, 8, 12, 16, 20, and 24 in patient-reported duration of benefit for their Botox injection, and length of time between injections.
Time Frame
Weeks 4, 8, 12, 16, 20, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will have received their last Botox injections 12-16 weeks ago
Any oral medications for cervical dystonia will be stable for 4 weeks and will continue throughout the study
Exclusion Criteria:
Less than 21 years old
Received Botox more than 16 weeks ago
Not on a stable dose of oral medications for cervical dystonia
12. IPD Sharing Statement
Learn more about this trial
Keppra for Cervical Dystonia
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