A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
NCT00603473
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
- Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
- Have not been able to achieve adequate seizure control with antiepileptic drugs
- Seizures related to drugs or acute medical illness
- History of any serious medical or psychiatric disorder
- Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be
progressive
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Obu-shi,Morioka-machi, Aichi
- Jonan-ku, Fukuoka
- Kobe, Hyogo
- Suma-Ku,Kobe, Hyogo
- Kanazawa, Ishikawa
- Zentsuuji, Kagawa
- Yokohama, Kanagawa Pref.
- Sendai-shi, Miyagi-ken
- Showa-Ku, Nagoya
- Niigata-shi, Niigata
- Kurashiki-City, Okayama Pref.
- Okayama-shi, Okayama
- Izumi-shi, Osaka
- Miyakojima-ku, Osaka
- Suita, Osaka
- Shizuoka-shi, Shizuoka
- Kodaira, Tokyo
- Setagaya-ku, Tokyo
- Shinjuku-ku, Tokyo
- Hiroshima,
- Saitama,
- Yamagata,
- Mobile, Alabama
- Mobile, Alabama
- Phoenix, Arizona
- Jonesboro, Arkansas
- Little Rock, Arkansas
- San Francisco, California
- Gulf Breeze, Florida
- Pensacola, Florida
- Tampa, Florida
- Tampa, Florida
- Springfield, Missouri
- Buffalo, New York
- Durham, North Carolina
- Houston, Texas
- San Antonio, Texas
- Seoul,
- Mexico, DF
- Guadalajara, Jalisco
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures | |||
Official Title ICMJE | An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects | |||
Brief Summary | Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Epilepsies, Partial | |||
Intervention ICMJE | Drug: gabapentin
Orally administered gabapentin | |||
Study Arms ICMJE | Experimental: gabapentin
Intervention: Drug: gabapentin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 92 | |||
Original Estimated Enrollment ICMJE | 95 | |||
Actual Study Completion Date ICMJE | December 2009 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 3 Years to 15 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00603473 | |||
Other Study ID Numbers ICMJE | A9451162 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trials Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |