Phase II BGG492 Capsule Extension for Partial Epilepsy

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01338805

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.

Condition or Disease	Intervention/Treatment	Phase
Partial Onset Seizures	Drug: BGG492	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Open-label, Follow-up Study to Evaluate the Long-term Safety and Tolerability of BGG492 TID as Adjunctive Therapy in Patients With Partial Onset Seizures Completing Double-blind, Placebo-controlled Study CBGG492A2207 or CBGG492A2211

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BGG492 hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID	Drug: BGG492

Arm

Intervention/Treatment

Experimental: BGG492

hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID

Drug: BGG492

Outcome Measures

Primary Outcome Measures

To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures [38 weeks]
By measuring the number and percent of patients having any AE (advent event) by primary system organ class and/or preferred term. By laboratory, vital sign, and ECG data, summary statistics of values and change from baseline

Secondary Outcome Measures

To evaluate the efficacy over time by the change in partial seizure frequency original Baseline Period in the double-blind study CBGG492A2207 to the Open-label Extension Maintenance Phase. [38 weeks]
Responder rate: To evaluate the maintenance of efficacy by the change in responder rate and numbers of patients becoming seizure free from the original Baseline Period to the Open-label Extension Maintenance Phase. [38 weeks]
Seizure counts: To evaluate the maintenance of efficacy and safety as assessed in percent change of seizure frequency of BGG492 capsules from the original Baseline Period to the Open-label Extension Maintenance Phase. [38 weeks]
To evaluate long-term efficacy and safety by summarizing the number and percentage of patients who discontinue due to unsatisfactory therapeutic response effect and for all other reasons. [30 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 66 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Completed study CBGG492A2207, cooperated with the study procedures and did not experience persistent tolerability issues
Outpatients ≥ 45 kg (99 lb) of weight
Patient would like to continue BGG492 treatment and the investigator believes a reasonable benefit from the long-term administration of BGG492 may be expected
Treated with a stable dose of one or a maximum of three licensed Antiepileptic drugs (AEDs)and are known to take their medication(s) as directed
Will make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events
Provided written informed consent before any extension assessment is performed

Exclusion Criteria:

Status epilepticus or seizure clusters occurring during study CBGG492A2207 or in the period between the end of study the double blind study and the start of study CBGG492A2212 for patients experiencing a treatment gap
Have been treated with:
Felbamate, unless treatment has been continuous for ≥ 2 years
Vigabatrin during the 26 weeks prior to the first dose of open-label medication in the extension study
Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics
L-Dopa formulations
Use of concomitant medication that are potential inhibitors of Organic anion-transporting polypeptide (OATP) transporters
No physical examination changes suggestive of progressive neurological changes during Study CBGG492A2207
Used another investigational drug (other than BGG492) either at the time of enrollment in this extension study or within 5 half-lives prior to enrollment in this extension study
History of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides) or had multiple drug allergies or one or more severe drug reactions to an Antiepileptic drugs (AEDs), including dermatological reactions
Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Tallahassee	Florida	United States	32308
2	Novartis Investigative Site	Hamilton	New Jersey	United States	08619
3	Novartis Investigative Site	Dallas	Texas	United States	75230
4	Novartis Investigative Site	Bernau		Germany	16321
5	Novartis Investigative Site	Bielefeld		Germany	33617
6	Novartis Investigative Site	Bonn		Germany	53105
7	Novartis Investigative Site	Kehl-Kork		Germany	77694
8	Novartis Investigative Site	Ulm		Germany	89081
9	Novartis Investigative Site	Budapest		Hungary	1096
10	Novartis Investigative Site	Kecskemet		Hungary	6000
11	Novartis Investigative Site	Szombathely		Hungary	9700
12	Novartis Investigative Site	Seoul	Korea	Korea, Republic of	110 744
13	Novartis Investigative Site	Seoul	Korea	Korea, Republic of	135-710
14	Novartis Investigative Site	Warsaw		Poland	02-957
15	Novartis Investigative Site	Banska Bystrica		Slovakia	97517
16	Novartis Investigative Site	Kosice		Slovakia	041 90