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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01098162
Other study ID # SP0973
Secondary ID
Status Completed
Phase N/A
First received April 1, 2010
Last updated August 22, 2014
Start date March 2010
Est. completion date July 2013

Study information

Verified date August 2014
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
Study type Observational

Clinical Trial Summary

The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 576
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat®

- The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study

- The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient

- The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures

- Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®

Exclusion Criteria:

In accordance with the Summary of Product Characteristics (SmPC)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany 55 Aachen
Germany 119 Aalen
Germany 194 Aichach
Germany 191 Altenburg
Germany 136 Alzenau
Germany 78 Aschaffenburg
Germany 35 Bad Berka
Germany 90 Baesweiler
Germany 107 Berlin
Germany 10A Berlin
Germany 141 Berlin
Germany 25 Berlin
Germany 49 Berlin
Germany 66 Berlin
Germany 75 Berlin
Germany 36 Bielefeld
Germany 192 Böblingen
Germany 5 Bonn
Germany 175 Brandenburg
Germany 105 Chemnitz
Germany 182 Coppenbrügge
Germany 161 Dortmund
Germany 128 Dresden
Germany 21 Dresden
Germany 39 Dresden
Germany 111 Düren
Germany 38 Düsseldorf
Germany 7 Eberswalde
Germany 102 Eisenach
Germany 174 Eisenach
Germany 56 Ellwangen
Germany 50 Erbach
Germany 179 Erfurt
Germany 186 Erfurt
Germany 6 Erlangen
Germany 12 Essen
Germany 27 Freiburg
Germany 137 Fulda
Germany 112 Gelsenkirchen
Germany 103 Gera
Germany 158 Göttingen
Germany 65 Göttingen
Germany 88 Göttingen
Germany 1 Greifswald
Germany 47 Grevenbroich
Germany 134 Halle (Saale)
Germany 160 Hamburg
Germany 71 Hamburg
Germany 93 Hamm
Germany 147 Heilbronn
Germany 122 Herborn
Germany 15 Herdecke
Germany 130 Höchberg
Germany 40 Immenstadt
Germany 52 Jena
Germany 61 Jülich
Germany 44 Karlstadt
Germany 133 Kastellaun
Germany 125 Kaufbeuren
Germany 16 Kiel
Germany 99 Kleve
Germany 176 Köln
Germany 180 Köln
Germany 37 Krefeld
Germany 46 Lappersdorf
Germany 113 Leipzig
Germany 4 Leipzig
Germany 68 Leipzig
Germany 81 Leipzig
Germany 138 Lohr am Main
Germany 148 Lüdenscheid
Germany 131 Ludwigsburg
Germany 33 Mainz
Germany 154 Mannheim
Germany 151 Mühlhausen
Germany 101 München
Germany 167 München
Germany 2 München
Germany 43 Neuburg
Germany 62 Neukirchen-Vluyn
Germany 123 Neumarkt
Germany 69 Nürnberg
Germany 80 Oelde
Germany 98 Oldenburg
Germany 87 Oranienburg
Germany 57 Potsdam
Germany 3 Radeberg
Germany 159 Rathenow
Germany 45 Ravensburg
Germany 95 Rostock
Germany 85 Rüsselsheim
Germany 20 Schleswig
Germany 157 Schlüchtern
Germany 166 Schorndorf
Germany 181 Schriesheim
Germany 150 Schwäb. Gmünd
Germany 168 Schwedt
Germany 140 Senftenberg
Germany 164 Siegen
Germany 144 Sondershausen
Germany 127 Stralsund
Germany 14 Stuttgart
Germany 170 Stuttgart
Germany 104 Traunstein
Germany 183 Troisdorf
Germany 17 Tübingen
Germany 13 Ulm
Germany 48 Ulm
Germany 54 Unterhaching
Germany 171 Wermsdorf
Germany 143 Westerstede
Germany 79 Wismar
Germany 169 Wolfratshausen

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Global Impression of Change (CGI-C) at Month 6 For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
Month 6 No
Secondary Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures.
From Baseline to Month 3 No
Secondary Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures can be classified into one of the following three groups:
Simple partial seizures
Complex partial seizures
Partial seizures evolving to secondarily generalized seizures.
From Baseline to Month 6 No
Secondary Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
Simple partial seizures evolving to generalized seizures
Complex partial seizures evolving to generalized seizures
Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.
From Baseline to Month 3 No
Secondary Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6 Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.
Change in number of partial-onset seizures with secondary generalization was derived as follows:
Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days).
A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.
Partial-onset seizures with secondary generalization can be classified into one of the following three groups:
Simple partial seizures evolving to generalized seizures
Complex partial seizures evolving to generalized seizures
Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.
From Baseline to Month 6 No
Secondary Incidence of Adverse Events During the Study The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below. From Inclusion Visit (Day 0) up to Month 6 No
See also
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Completed NCT00143143 - Pregabalin Open-Label Extension Trial in Patients With Partial Seizures Phase 3
Completed NCT00771927 - Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures N/A
Completed NCT00236873 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures. Phase 2
Completed NCT01745952 - Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS) N/A
Completed NCT00772603 - Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures Phase 3
Completed NCT00280696 - A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures Phase 3
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Withdrawn NCT00422110 - A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures Phase 2/Phase 3
Completed NCT00620555 - A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures Phase 3
Completed NCT00448916 - Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures Phase 3
Completed NCT00210522 - An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy Phase 2
Completed NCT00236886 - Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients Phase 3
Completed NCT00236860 - A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures Phase 2
Active, not recruiting NCT03689114 - Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) Phase 4
Completed NCT05273398 - Effects of Diazepam on RNS Detections Phase 4
Completed NCT00918047 - Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients Phase 1