Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

Epilepsies, Partial Clinical Trial

— VITOBA  

Official title:

A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098162
• Other study ID #: SP0973
• 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

• Epilepsies, Partial
• Epilepsy

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

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