Partial Onset SeizuresPhase 2NCT01338805
Phase II BGG492 Capsule Extension for Partial Epilepsy
A Phase 2 study testing BGG492 in people with Partial Onset Seizures, run by Novartis Pharmaceuticals at 16 sites in 6 countries.
Trial summary
This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Partial Onset Seizures
- What is being tested?
- BGG492
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 16 sitesin 6 countries
- Study dates
- Jun 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Germany5 sites
Novartis Investigative Site
Bernau, 16321
Novartis Investigative Site
Bielefeld, 33617
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Kehl-Kork, 77694
Novartis Investigative Site
Ulm, 89081
United States3 sites
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Hamilton, New Jersey, 08619
Novartis Investigative Site
Tallahassee, Florida, 32308
Hungary3 sites
Novartis Investigative Site
Budapest, 1096
Novartis Investigative Site
Kecskemét, 6000
Novartis Investigative Site
Szombathely, 9700
Slovakia2 sites
Novartis Investigative Site
Banská Bystrica, 97517
Novartis Investigative Site
Košice, 041 90
South Korea2 sites
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, Korea, 135-710
About this study
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
This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.
- Conditions
- Partial Onset Seizures
- Being tested
- BGG492
- Keywords
- Partial onset seizure, seizure frequency, nervous system diseases, central nervous system diseases, CNS, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug
- Medical subject headings
- Nervous System Diseases, Central Nervous System Diseases, Brain Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGG492Drug
| Study group | Role | What they receive |
|---|---|---|
| BGG492 | Experimental | hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID Receives: Drug: BGG492 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures
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
Measured: 38 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Onset SeizuresStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338805
- Sponsor's protocol ID
- CBGG492A2212
- Other IDs
- 2010-021448-17
- Status last verified
- Mar 2016
- First submitted
- 15 Apr 2011
- Last updated
- 5 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01338805
- Acronym / sponsor ID
- CBGG492A2212
- Conditions
- Partial Onset Seizures
- Keywords
- Partial onset seizure, seizure frequency, nervous system diseases, central nervous system diseases, CNS, brain diseases, neurologic manifestations, adjunctive treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This long-term extension study will assess the safety, tolerability and efficacy of BGG492 as adjunctive treatment in patients with partial onset seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGG492 | Experimental | Drug: BGG492hard gelatin capsule for oral administration at 50 mg TID, 100 mg TID or 150 mg TID |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGG492 | Drug | BGG492 |
Primary outcome
To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures
Time frame: 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
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Results for CBGG492A2212 from the Novartis Clinical Trials websiteLink provided by the sponsor.
Related trials for Partial Onset Seizures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGG492 in people with Partial Onset Seizures, run by Novartis Pharmaceuticals at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, United States, Hungary, Slovakia, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures (time frame: 38 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.