NCT00150813

Brief Summary

An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2005

Geographic Reach
4 countries

21 active sites

Status
completed

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

August 10, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2007

Completed
11.4 years until next milestone

Results Posted

Study results publicly available

October 1, 2018

Completed
Last Updated

November 21, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

September 6, 2005

Results QC Date

February 8, 2018

Last Update Submit

October 23, 2018

Conditions

Epilepsy, Tonic-clonic

Keywords

MonotherapyEpilepsyKeppraLevetiracetam

Outcome Measures

Primary Outcomes (1)

  • Percentage Participants With Treatment Emergent Adverse Events

    An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).

    From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Subjects received open-label Levetiracetam.

Drug: Levetiracetam

Interventions

LevetiracetamDRUG

Pharmaceutical form: oral tablets Route of administration: Oral use

Also known as: Keppra
Levetiracetam

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a confirmed diagnosis of epilepsy.
  • Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
  • Subjects having participated in the previous double-blind monotherapy trial (N01061 \[NCT00150735\] or N01093 \[NCT00150787\]).
  • Male/female subjects (\>= 16 years).

You may not qualify if:

  • \- Need for an additional Antiepileptic Drug (AED).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Beroun, Czechia

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

České Budějovice, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Rychnov nad Kněžnou, Czechia

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Debrecen, Hungary

Location

Unknown Facility

Pécs, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Szczecin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Helsingborg, Sweden

Location

Unknown Facility

Huddinge, Sweden

Location

Unknown Facility

Karlstad, Sweden

Location

Unknown Facility

Uppsala, Sweden

Location

Related Links

MeSH Terms

Conditions

Epilepsy, Tonic-ClonicEpilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
UCB
Organization
Cares
UCBCares@ucb.com
+1844 599

Study Officials

  • UCB Cares

    001 844 599 2273 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

August 10, 2005

Primary Completion

May 29, 2007

Study Completion

May 29, 2007

Last Updated

November 21, 2018

Results First Posted

October 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

HU(4)PL(7)SE(5)CZ(5)