Partial Onset SeizuresPhase 2NCT01147003
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
A Phase 2 study testing Investigational new drug, company code: BGG492 in people with Partial Onset Seizures, run by Novartis at 51 sites in 10 countries.
Trial summary
This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Partial Onset Seizures
- What is being tested?
- Investigational new drug, company code: BGG492
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 51 sitesin 10 countries
- Study dates
- Jun 2010to Sep 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 antiepileptic drugs (AEDs) within the last 2 years prior to screening.
- 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.
- Cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 AEDs.Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs.
Who cannot join
- 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.
- Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization.
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
51 sites in 10 countries.
51 sites in 10 countries
United States14 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Neurological Clinic of Texas
Dallas, Texas, 75230
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
Medical Center of the Rockies
Loveland, Colorado, 80538
NYU Comprehensive Epilepsy Center
New York, New York, 10016
Investigative Site - Private Practice
Ocean Springs, Mississippi, 39564
Thomas Jefferson University, Dept. of Psychiatry & Neurology
Philadelphia, Pennsylvania, 19107
Barrow Neurological Clinics at St. Joseph's Hospital and MC
Phoenix, Arizona, 85013
Renown Institute for Neurosciences
Reno, Nevada, 89521
NJ to Capital Health in Hamilton
Somerset, New Jersey, 08873
Princeton and Rutgers Neurology
Somerset, New Jersey, 08873
St.John's Research Institute, Inc
Springfield, Missouri, 65804
AMO Corporation
Tallahassee, Florida, 32308
Center for Neurosciences
Tucson, Arizona, 85718
Germany8 sites
Novartis Investigative Site
Bernau, 16321
Novartis Investigative Site
Bielefeld, 33617
Novartis Investigative Site
Bonn, 53127
Novartis Investigative Site
Kehl-Kork, 77694
Novartis Investigative Site
Marburg
Novartis Investigative SIte
Regensburg
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Ulm
Italy7 sites
Novartis Investigative Site
Bologna, 40123
Novartis Investigative Site
Catanzaro, 88100
Novartis Investigative Site
Florence, 50143
Novartis Investigative Site
Milan, 20142
Novartis Investigative Site
Milan, 40123
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Venezia, 30122
Taiwan5 sites
Novartis Investigative Site
Changhua
Novartis Investigative Site
Kaohsiung City
Novartis Investigative Site
Lin-ko, 33305
Novartis Investigative Site
Taipei, 112
Novartis Investigative Site
Taipei
South Korea4 sites
Novartis Investigative Site
Seoul, 110-744
Novartis Investigative Site
Seoul, 120-752
Novartis Investigative Site
Seoul, 135-710
Novartis Investigative Site
Seoul, 738-736
Hungary3 sites
Novartis Investigative Site
Budapest, 1096
Novartis Investigative Site
Kecskemét, 6000
Novartis Investigative Site
Szombathely, 9700
Poland3 sites
Novartis Investigative Site
Gdansk, 80-303
Novartis Investigative Site
Krakow, 31-209
Novartis Investigative Site
Warsaw, 02-957
Slovakia3 sites
Novartis Investigative Site
Banská Bystrica, 975 17
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Košice, 041 90
Switzerland3 sites
Novartis Investigative Site
Aarau, 5001
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Zurich, 8008
About this study
Official title: A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures
This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
- Conditions
- Partial Onset Seizures
- Being tested
- Investigational new drug, company code: BGG492, Placebo
- Keywords
- Seizure frequency, nervous system diseases, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug
- Medical subject headings
- 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.
Investigational new drug, company code: BGG492Drug
PlaceboDrug
Investigational new drug, company code: BGG492Drug
| Study group | Role | What they receive |
|---|---|---|
| BGG492 low dose | Experimental | Not described Receives: Drug: Investigational new drug, company code: BGG492 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BGG492 high dose | Experimental | Not described Receives: Drug: Investigational new drug, company code: BGG492 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
Measured: 28 days
Secondary outcomes (4)
To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.
Measured: 28 days
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
Measured: 28 days
Safety and tolerability of BGG492 compared to placebo.
Measured: 12 weeks
Pharmacokinetic profile of BGG492
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147003
- Sponsor's protocol ID
- CBGG492A2207
- Other IDs
- 2009-017961-52, 2009
- Status last verified
- Mar 2013
- First submitted
- 15 Jun 2010
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures
- ClinicalTrials.gov ID
- NCT01147003
- Acronym / sponsor ID
- CBGG492A2207
- Conditions
- Partial Onset Seizures
- Keywords
- Seizure frequency, nervous system diseases, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Jun 2010 (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 study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BGG492 low dose | Experimental | Drug: Investigational new drug, company code: BGG492 |
| Placebo | Placebo comparator | Drug: Placebo |
| BGG492 high dose | Experimental | Drug: Investigational new drug, company code: BGG492 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 antiepileptic drugs (AEDs) within the last 2 years prior to screening.
- 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.
- Cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 AEDs.Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs.
Key exclusion criteria (7 listed)
- 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.
- Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization.
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 |
|---|---|---|
| Investigational new drug, company code: BGG492 | Drug | BGG492 low dose |
| Placebo | Drug | Placebo |
| Investigational new drug, company code: BGG492 | Drug | BGG492 high dose |
Primary outcome
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
Time frame: 28 days
4 secondary outcomes
To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.
Time frame: 28 days
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
Time frame: 28 days
Safety and tolerability of BGG492 compared to placebo.
Time frame: 12 weeks
Pharmacokinetic profile of BGG492
Time frame: 10 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 17 Dec 2020.
- Results for CBGG492A2207 on the Novartis clinical trials websiteLink provided by the sponsor.
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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
51 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational new drug, company code: BGG492 in people with Partial Onset Seizures, run by Novartis at 51 sites in 10 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 5 inclusion and 7 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Germany, Italy, Taiwan, South Korea and 5 more countries. 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. Some participants in this study may receive a placebo. 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 detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period. (time frame: 28 days). 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 17 Dec 2020.