Partial Onset SeizuresPhase 2NCT01167335
Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
A Phase 2 study testing BGG492 in people with Partial Onset Seizures, run by Novartis at 23 sites in 11 countries.
Trial summary
This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory 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?
- BGG492
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 23 sitesin 11 countries
- Study dates
- Aug 2010to Nov 2010
- 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 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
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
- 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
Trial locations and contacts
23 sites in 11 countries.
23 sites in 11 countries
India4 sites
Novartis Investigative Site
Bangalore, Karnataka, 560054
Novartis Investigative Site
Dehli, New Delhi, 110002
Novartis Investigative Site
Jaipur, 302004
Novartis Investigative Site
Mumbai, Maharashtra, 400012
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Epilepsy Care Specialists, S.C.
Milwaukee, Wisconsin, 53215
University of South Alabama
Mobile, Alabama, 36693
Austria3 sites
Novartis Investigative Site
Salzburg, A-5020
Novartis Investigative Site
Vienna, 1090
Novartis Investigational Site
Vienna, 1130
Belgium2 sites
Novartis Investigative Site
Duffel, 2570
Novartis Investigative Site
Ottignies, 1340
Canada2 sites
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2J2
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Estonia2 sites
Novartis Investigative Site
Tallinn, 10617
Novartis Investigative Site
Tartu, 51014
Latvia2 sites
Novartis Investigative Site
Riga, 1002
Novartis Investigative Site
Riga, LV-1038
Romania2 sites
Novartis Investigative Site
Bucharest, 011635
Novartis Investigative Site
Bucharest, 024092
About this study
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
This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures
- Conditions
- Partial Onset Seizures
- Being tested
- BGG492, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BGG492 | Experimental | Not described Receives: Drug: BGG492 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
Measured: 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.
Measured: 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
Measured: 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.)
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 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
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
- 0 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
- NCT01167335
- Sponsor's protocol ID
- CBGG492A2211
- Other IDs
- 2010-018766-23
- Status last verified
- Apr 2012
- First submitted
- 25 Jun 2010
- Last updated
- 1 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01167335
- Acronym / sponsor ID
- CBGG492A2211
- 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
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- First posted
- 22 Jul 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 of BGG492 as adjunctive treatment in patients with refractory 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
- 2
| Arm | Type | Receives |
|---|---|---|
| BGG492 | Experimental | Drug: BGG492 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 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.
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
- Pregnant or nursing (lactating) women
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 |
| Placebo | Drug | Placebo |
Primary outcome
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
Time frame: 28 days
3 secondary outcomes
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 evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks
Time frame: 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.)
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
Related trials for Partial Onset Seizures
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RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
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A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures
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
23 sites in 11 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 at 23 sites in 11 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 7 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: withdrawn, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in India, United States, Austria, Belgium, Canada and 6 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 was withdrawn before enrolling participants, so there are no results.
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?
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the 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 1 May 2012.