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CompletedNCT00160576Updated Dec 6, 2013

Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias

A Phase 2 interventional study of Levetiracetam in Idiopathic Parkinson Disease, sponsored by UCB Pharma. Completed. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2013-12-06.

Sponsored by UCB Pharma · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
30 Years and older
Sex
All
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Study summary

This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease, without negative impact on the benefit on the motor function of the antiparkinsonian treatment.

02

Conditions studied

  • Idiopathic Parkinson Disease

Keywords

  • Idiopathic Parkinson's Disease, levodopa induced dyskinesia,
  • Levetiracetam, Keppra
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All

Inclusion criteria

  1. Male / female adult, 30 years old or more;
  2. Subject suffering from Idiopathic Parkinson's Disease, diagnosed according to the UK Brain Bank Criteria (see Appendix 14.8) (1) , since a minimum of 3 years, and stabilized with regard to the motor function (ratio .on./.off. over the day);
  3. Subject treated with levodopa whether or not combined with any other antiparkinsonian drugs (except apomorphine) for minimum one year;
  4. Subject experiencing during .on. periods, despite several attempts of treatment adjustment, persistent troublesome dyskinesias:

    1. with a minimum score of 2 on item 33 of the UPDRS-Part IV (moderately disabling dyskinesias);
    2. with a minimum score of 2 on item 32 of the UPDRS-Part IV (dyskinesias present during more than 25% of the waking day).

Exclusion criteria

Exclusion Criteria:

  1. Dyskinesias that cannot reliably be characterized on a regular basis by the subject himself/herself (more than 5 .errors. on DRC per 24 hours after repeated training);
  2. Subject currently treated with apomorphine or neuroleptic drugs either typical or atypical such as clozapine, olanzapine or risperidone;
  3. Subject currently treated with dopamine antagonists such as but not limited to metoclopramide, alizapride or phenothiazine derivatives (e.g. metopimazine). If necessary, the use of the dopamine antagonist domperidone is allowed.
  4. Subject Who had undergone or who was scheduled for functional neurosurgery for Parkinson's disease during the trial period;
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Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • DrugLevetiracetam
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What researchers measure

Primary outcomes

  1. Evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease by assessing the reduction in mean duration of dyskinesias during "on" period at 10-week

Secondary outcomes

  1. Reduction in mean duration of dyskinesias per day at 9 month;Safety

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00160576
Lead sponsor
UCB Pharma
First posted
Sep 12, 2005
Start date
Jul 2003
Primary completion
Nov 2004
Completion
Nov 2004
Last update
Dec 6, 2013

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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