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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00160576
Other study ID # N01105
Secondary ID
Status Completed
Phase Phase 2
First received September 8, 2005
Last updated December 5, 2013
Start date July 2003
Est. completion date November 2004

Study information

Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Portugal: National Pharmacy and Medicines Institute
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 2004
Est. primary completion date November 2004
Accepts healthy volunteers
Gender Both
Age group 30 Years and older
Eligibility 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:

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;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Drug:
Levetiracetam


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Reduction in mean duration of dyskinesias per day at 9 month;Safety
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