Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older

NCT01236001 | Completed Results

• 1 other identifier: SP1021
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 17

Brief Summary

Observational study at the request of the Belgian Institut National d'Assurance Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:

• type of patient treated with VIMPAT®
• VIMPAT® dose
• Effect of VIMPAT® on evolution of seizure control
• Persistence rate at 6 months in terms of treatment duration
• Discontinuation rate
• Description of any changes in other epilepsy therapies
• Safety and tolerability

Conditions

Seizures

Keywords

Lacosamide; Vimpat®

Outcome Measures

Primary Outcomes (6)

• Mean Total Daily Dose of VIMPAT® (mg) at Baseline

  Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.

  Baseline

• Mean Total Daily Dose of VIMPAT® (mg) at 3 Months

  3 months

• Mean Total Daily Dose of VIMPAT® (mg) at 6 Months

  6 months

• Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline

  This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.

  Baseline

• Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months

  VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.

  3 months

• Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months

  VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.

  6 months

Secondary Outcomes (5)

• Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment

  From baseline to study termination (6 months)

• Treatment Persistence of VIMPAT® After 6 Months

  >=6 months

• Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline

  Baseline

• Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months

  3 months

• Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months

  6 months

Study Arms (1)

Vimpat® treatment

Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.

Drug: Lacosamide

Interventions

Lacosamide DRUG

Also known as: VIMPAT®

Vimpat® treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Routine clinical practice of neurologist / neuropsychiatrist / neurosurgeon / neuropediatrician Sampling based upon request by the Belgian reimbursement authorities: request to report on 100 patients

You may qualify if:

• An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form
• Subject/legal representative is considered reliable and capable of adhering to the medication intake according to the judgement of the investigator
• Based on the investigators clinical judgement, the subjects' seizure activity is uncontrolled on current therapy and it is in the subjects' best interest to be prescribed an antiepileptic drug (AED) as adjunctive therapy. The choice to prescribe VIMPAT® as adjunctive therapy is made by the treating investigator
• The subject is aged 16 or older
• The subject has a diagnosis of epilepsy with partial-onset seizures according to the label
• The subject has a medication history with at least 3 AED therapies (lifetime and/or concomitant) with treatment failure: due to insufficient efficacy, due to significant adverse events
• Sufficient data on the clinical situation before start of VIMPAT® and information on VIMPAT® dosing are present in the subject's medical record for patients on treatment with VIMPAT® at the time of enrollment into the study

You may not qualify if:

• The subject has previously participated in this study or has participated in a clinical trial within the last 2 months
• The subject has a history of chronic alcohol or drug abuse within the last 6 months
• The subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
• The subject has a known hypersensitivity and/or allergy to soya, peanuts, or any component of VIMPAT®
• The subject is pregnant or lactating
• The subject has a known AV-block degree 2 or 3
• The subject is expected to be insufficiently compliant with contraception.
• The subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (17)

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Assebroek, Belgium

Location

Unknown Facility

Bruges, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Charleroi, Belgium

Location

Unknown Facility

Duffel, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Hasselt, Belgium

Location

Unknown Facility

La Louvière, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Marche-en-Famenne, Belgium

Location

Unknown Facility

Mons, Belgium

Location

Unknown Facility

Montegnée - Liege, Belgium

Location

Unknown Facility

Ottignies-Louvain-la-Neuve, Belgium

Location

Unknown Facility

Yvoir, Belgium

Location

MeSH Terms

Conditions

Seizures

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center

+1 887 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 8, 2013
• Results First Posted: August 8, 2013

Record last verified: 2013-08

Locations

BE (17)