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Keppra for Cervical Dystonia

This study has suspended participant recruitment.
(Sponsor decided to stop enrollment to review data.)
Sponsor:
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00760318
First received: September 24, 2008
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Cervical Dystonia
Drug: Keppra
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Double Blind Evaluation of Levetiracetam (Keppra) for the Treatment of Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Primary endpoint will be the difference in change in TWSTRS score from baseline to week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

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. [ Time Frame: Weeks 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: November 2005
Estimated Study Completion Date: December 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Keppra
    There will be flexible dose titration increasing by 250 mg per week for 12 weeks to a maximum of 3000 mg divided BID.
    Other Name: levetiracetam
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Robert A. Hauser, MD, MBA, University of South Florida
ClinicalTrials.gov Identifier: NCT00760318     History of Changes
Other Study ID Numbers: UCB Pharma- Keppra
Study First Received: September 24, 2008
Last Updated: September 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
cervical dystonia, keppra, botox, spasmodic torticollis

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Anticonvulsants
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014