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Keppra for Cervical Dystonia (Keppra)

Primary Purpose

Cervical Dystonia

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Keppra
Sponsored by
University of South Florida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring cervical dystonia, keppra, botox, spasmodic torticollis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 24, 2008
    Last Updated
    November 21, 2018
    Sponsor
    University of South Florida
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    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

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    Keppra for Cervical Dystonia

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