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

NCT01167335 | Withdrawn Phase 2

• 2 other identifiers: CBGG492A22112010-018766-23
• Study Type: interventional
• Target: N/A
• Locations: 10 countries
• Sites: 22

Brief Summary

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

Conditions

Partial Onset Seizures

Keywords

partial onset seizure; seizure frequency; nervous system diseases; central nervous system diseases; CNS; brain diseases; neurologic manifestations; adjunctive treatment; AEDs; antiepileptic drug

Outcome Measures

Primary Outcomes (1)

• Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.

  28 days

Secondary Outcomes (3)

• Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.

  28 days

• 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

• 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

Study Arms (2)

BGG492

EXPERIMENTAL

Drug: BGG492

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BGG492 DRUG

BGG492

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (23)

University of South Alabama

Mobile, Alabama, 36693, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Epilepsy Care Specialists, S.C.

Milwaukee, Wisconsin, 53215, United States

Location

Novartis Investigative Site

Salzburg, A-5020, Austria

Location

Novartis Investigative Site

Vienna, 1090, Austria

Location

Novartis Investigational Site

Vienna, 1130, Austria

Location

Novartis Investigative Site

Duffel, 2570, Belgium

Location

Novartis Investigative Site

Ottignies, 1340, Belgium

Location

Novartis Investigative Site

Sofia, 1113, Bulgaria

Location

Novartis Investigative Site

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2L 4M1, Canada

Location

Novartis Investigative Site

Tallinn, 10617, Estonia

Location

Novartis Investigative Site

Tartu, 51014, Estonia

Location

Novartis Investigative Site

Bangalore, Karnataka, 560054, India

Location

Novartis Investigative Site

Mumbai, Maharashtra, 400012, India

Location

Novartis Investigative Site

Dehli, New Delhi, 110002, India

Location

Novartis Investigative Site

Jaipur, 302004, India

Location

Novartis Investigative Site

Riga, 1002, Latvia

Location

Novartis Investigative Site

Riga, LV-1038, Latvia

Location

Novartis Investigative Site

Kaunas, 50009, Lithuania

Location

Novartis Investigative Site

Bucharest, 011635, Romania

Location

Novartis Investigative Site

Bucharest, 024092, Romania

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Nervous System Diseases; Central Nervous System Diseases; Brain Diseases; Neurologic Manifestations

Interventions

selurampanel

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 22, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

RO (2); ES (2); IN (4); BE (2); LI (1); LA (2); AU (3); CA (2); US (3); BU (1)