Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Partial Onset Seizures Clinical Trial

Official title:

A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01167335
• Other study ID #: CBGG492A2211
• Secondary ID: 2010-018766-23
• Status: Withdrawn
• Phase: Phase 2
• First received: June 25, 2010
• Last updated: April 30, 2012
• Start date: August 2010

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyCanada: Health CanadaEstonia: The State Agency of MedicineIndia: Drugs Controller General of IndiaLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthRomania: National Medicines AgencySpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Outpatients = 50 kg (110 lb) of weight

• A diagnosis of epilepsy (= 2 years prior to screening) with partial seizures with or without secondarily generalized seizures

• Uncontrolled partial seizures despite having been treated with at least two different AEDs within the last 2 years prior to screening.

• Treated with a stable dose of 1-2 AEDs

• At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.

• No 28-day seizure-free period during the 8 weeks preceding randomization

• Positive biomarker screening

Exclusion Criteria:

• Presence of only non-motor simple partial seizures

• History of psychogenic seizures

• Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;

• Previous history of Lennox-Gastaut syndrome

• Pregnant or nursing (lactating) women

• Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Partial Onset Seizures
• Seizures

Intervention

Drug:
• BGG492

• Placebo

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigational Site	Wien
Belgium	Novartis Investigative Site	Duffel
Belgium	Novartis Investigative Site	Ottignies
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Dehli	New Delhi
India	Novartis Investigative Site	Jaipur
India	Novartis Investigative Site	Mumbai	Maharashtra
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Lithuania	Novartis Investigative Site	Kaunas
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Spain	Novartis Investigative Site	Barcelona
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Epilepsy Care Specialists, S.C.	Milwaukee	Wisconsin
United States	University of South Alabama	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Canada,  Estonia,  India,  Latvia,  Lithuania,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.		28 days	No
Secondary	Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.		28 days	No
Secondary	Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks		12 weeks	Yes
Secondary	Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.)		10 weeks	No