NCT00760318

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
Last Updated

November 23, 2018

Status Verified

September 1, 2008

Enrollment Period

1.9 years

First QC Date

September 24, 2008

Last Update Submit

November 21, 2018

Conditions

Cervical Dystonia

Keywords

cervical dystonia, keppra, botox, spasmodic torticollis

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint will be the difference in change in TWSTRS score from baseline to week 16.

    Week 16

Secondary Outcomes (1)

  • 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.

    Weeks 4, 8, 12, 16, 20, 24

Interventions

KeppraDRUG

There will be flexible dose titration increasing by 250 mg per week for 12 weeks to a maximum of 3000 mg divided BID.

Also known as: levetiracetam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Less than 21 years old
  • Received Botox more than 16 weeks ago
  • Not on a stable dose of oral medications for cervical dystonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Torticollis

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 26, 2008

Study Start

November 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

November 23, 2018

Record last verified: 2008-09