Dyskinesia, Medication-inducedPhase 2NCT00175955
Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia
A Phase 2 study testing Levetiracetam in people with Dyskinesia, Medication-induced, run by UCB Pharma at 7 sites in 2 countries.
Trial summary
An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyskinesia, Medication-induced
- What is being tested?
- Levetiracetam
- How many people
- 70 participants
- Where
- 7 sitesin 2 countries
- Study dates
- May 2005to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Subjects between ages 18 and 80 years
- Subjects must have a diagnosis of stable axis I psychiatric disorder at least 6 months prior to screening
- Subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria
- Subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening
Who cannot join
- Presence of any axis II condition within 6 months prior to screening
- Huntington´s disease, idiopathic dystonia, Wilson´s disease, Sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia
- Start of drugs-other than neuroleptics- that can cause dyskinesia
- Presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Belgium6 sites
Study site
Antwerp
Study site
Bourgois
Study site
Gonce
Study site
Hulselmans
Study site
Liège
Study site
Roeselare
About this study
Official title: An 8-week Exploratory, Double-blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-induced Tardive Dyskinesia in Subjects With Stable Axis I Psychiatric Disorder, Aged From at Least 18 Years to 80 Years.
An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia
- Conditions
- Dyskinesia, Medication-induced
- Being tested
- Levetiracetam
- Keywords
- Neuroleptic-induced tardive dyskinesia, Keppra, Levetiracetam
- Medical subject headings
- Dyskinesia, Drug-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
Secondary outcomes (3)
Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
Effect on the primary psychiatric disorder
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyskinesia, Medication-inducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175955
- Sponsor's protocol ID
- N01142
- Other IDs
- EudraCT Number 2004-001302-27
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2005
- Last updated
- 6 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week Exploratory, Double-blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-induced Tardive Dyskinesia in Subjects With Stable Axis I Psychiatric Disorder, Aged From at Least 18 Years to 80 Years.
- ClinicalTrials.gov ID
- NCT00175955
- Acronym / sponsor ID
- N01142
- Conditions
- Dyskinesia, Medication-induced
- Keywords
- Neuroleptic-induced tardive dyskinesia, Keppra, Levetiracetam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects between ages 18 and 80 years
- Subjects must have a diagnosis of stable axis I psychiatric disorder at least 6 months prior to screening
- Subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria
- Subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening
Key exclusion criteria (4 listed)
- Presence of any axis II condition within 6 months prior to screening
- Huntington´s disease, idiopathic dystonia, Wilson´s disease, Sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia
- Start of drugs-other than neuroleptics- that can cause dyskinesia
- Presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam | Drug | – |
Primary outcome
Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
3 secondary outcomes
Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
Effect on the primary psychiatric disorder
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
UCB Pharma
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam in people with Dyskinesia, Medication-induced, run by UCB Pharma at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2013.