Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01147003
First received: June 15, 2010
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Partial Onset Seizures |
Drug: Investigational new drug, company code: BGG492 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Safety and tolerability of BGG492 compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetic profile of BGG492 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 93 |
| Study Start Date: | June 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BGG492 low dose | Drug: Investigational new drug, company code: BGG492 |
| Placebo Comparator: Placebo | Drug: Placebo |
| Experimental: BGG492 high dose | Drug: Investigational new drug, company code: BGG492 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147003
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Hide Study LocationsLocations
| United States, Arizona | |
| Barrow Neurological Clinics at St. Joseph's Hospital and MC | |
| Phoenix, Arizona, United States, 85013 | |
| Center for Neurosciences | |
| Tucson, Arizona, United States, 85718 | |
| United States, Arkansas | |
| Clinical Trials, Inc. | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Colorado | |
| Medical Center of the Rockies | |
| Loveland, Colorado, United States, 80538 | |
| United States, Florida | |
| AMO Corporation | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Mississippi | |
| Investigative Site - Private Practice | |
| Ocean Springs, Mississippi, United States, 39564 | |
| United States, Missouri | |
| St.John's Research Institute, Inc | |
| Springfield, Missouri, United States, 65804 | |
| United States, Nevada | |
| Renown Institute for Neurosciences | |
| Reno, Nevada, United States, 89521 | |
| United States, New Jersey | |
| NJ to Capital Health in Hamilton | |
| Somerset, New Jersey, United States, 08873 | |
| Princeton and Rutgers Neurology | |
| Somerset, New Jersey, United States, 08873 | |
| United States, New York | |
| NYU Comprehensive Epilepsy Center | |
| New York, New York, United States, 10016 | |
| United States, Pennsylvania | |
| Thomas Jefferson University, Dept. of Psychiatry & Neurology | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Neurological Clinic of Texas | |
| Dallas, Texas, United States, 75230 | |
| Bulgaria | |
| Novartis Investigative Site | |
| Sofia, Bulgaria, 1113 | |
| Germany | |
| Novartis Investigative Site | |
| Bernau, Germany, 16321 | |
| Novartis Investigative Site | |
| Bielefeld, Germany, 33617 | |
| Novartis Investigative Site | |
| Bonn, Germany, 53127 | |
| Novartis Investigative Site | |
| Kehl-Kork, Germany, 77694 | |
| Novartis Investigative Site | |
| Marburg, Germany | |
| Novartis Investigative SIte | |
| Regensburg, Germany | |
| Novartis Investigative Site | |
| Tuebingen, Germany, 72076 | |
| Novartis Investigative Site | |
| Ulm, Germany | |
| Hungary | |
| Novartis Investigative Site | |
| Budapest, Hungary, 1096 | |
| Novartis Investigative Site | |
| Kecskemet, Hungary, 6000 | |
| Novartis Investigative Site | |
| Szombathely, Hungary, 9700 | |
| Italy | |
| Novartis Investigative Site | |
| Bologna, Italy, 40123 | |
| Novartis Investigative Site | |
| Catanzaro, Italy, 88100 | |
| Novartis Investigative Site | |
| Firenze, Italy, 50143 | |
| Novartis Investigative Site | |
| Milano, Italy, 20142 | |
| Novartis Investigative Site | |
| Milano, Italy, 40123 | |
| Novartis Investigative Site | |
| Napoli, Italy, 80131 | |
| Novartis Investigative Site | |
| Venezia, Italy, 30122 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 738-736 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 120-752 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Poland | |
| Novartis Investigative Site | |
| Gdansk, Poland, 80-303 | |
| Novartis Investigative Site | |
| Krakow, Poland, 31-209 | |
| Novartis Investigative Site | |
| Warsaw, Poland, 02-957 | |
| Slovakia | |
| Novartis Investigative Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| Novartis Investigative Site | |
| Bratislava, Slovakia | |
| Novartis Investigative Site | |
| Kosice, Slovakia, 041 90 | |
| Switzerland | |
| Novartis Investigative Site | |
| Aarau, Switzerland, 5001 | |
| Novartis Investigative Site | |
| Bern, Switzerland, 3010 | |
| Novartis Investigative Site | |
| Zuerich, Switzerland, 8008 | |
| Taiwan | |
| Novartis Investigative Site | |
| Changhua, Taiwan | |
| Novartis Investigative Site | |
| Kaohsiung, Taiwan | |
| Novartis Investigative Site | |
| Lin-ko, Taiwan, 33305 | |
| Novartis Investigative Site | |
| Taipei, Taiwan, 112 | |
| Novartis Investigative Site | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01147003 History of Changes |
| Other Study ID Numbers: | CBGG492A2207, 2009-017961-52 |
| Study First Received: | June 15, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency Korea: Food and Drug Administration Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovakia: State Institute for Drug Control Switzerland: Ethikkommission Taiwan: Department of Health United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Seizure frequency nervous system diseases brain diseases neurologic manifestations |
adjunctive treatment AEDs antiepileptic drug |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013