A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00603473

Purpose

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

Condition	Intervention	Phase
Epilepsies, Partial	Drug: gabapentin	Phase III

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Gabapentin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

To confirm Response Ratio of Gabapentin in Japanese pediatric patients with partial seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Responder Rate, Percent change in seizure frequency, Pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	95
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
gabapentin: Experimental	Drug: gabapentin Orally administered gabapentin

Eligibility

Ages Eligible for Study:	3 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603473

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Japan
Pfizer Investigational Site	Recruiting
yamanashi, Japan
Pfizer Investigational Site	Recruiting
Hiroshima, Japan
Pfizer Investigational Site	Recruiting
Saitama, Japan
Pfizer Investigational Site	Not yet recruiting
Yamagata, Japan
Japan, Hyogo
Pfizer Investigational Site	Recruiting
Kobe, Hyogo, Japan
Japan, Ishikawa
Pfizer Investigational Site	Recruiting
Kanazawa, Ishikawa, Japan
Japan, Kagawa
Pfizer Investigational Site	Not yet recruiting
zentsuuji, Kagawa, Japan
Japan, Kanagawa Pref.
Pfizer Investigational Site	Recruiting
Yokohama, Kanagawa Pref., Japan
Japan, Miyagi-ken
Pfizer Investigational Site	Recruiting
Sendai-shi, Miyagi-ken, Japan
Japan, Nagoya
Pfizer Investigational Site	Recruiting
Showa-Ku, Nagoya, Japan
Japan, Niigata
Pfizer Investigational Site	Recruiting
Niigata-shi, Niigata, Japan
Japan, Okayama
Pfizer Investigational Site	Recruiting
Okayama-shi, Okayama, Japan
Japan, Osaka
Pfizer Investigational Site	Recruiting
Suita, Osaka, Japan
Pfizer Investigational Site	Recruiting
Izumi-shi, Osaka, Japan
Japan, Shizuoka
Pfizer Investigational Site	Recruiting
Shizuoka-shi, Shizuoka, Japan
Japan, Tokyo
Pfizer Investigational Site	Recruiting
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site	Recruiting
Kodaira, Tokyo, Japan
Pfizer Investigational Site	Recruiting
Kiyose-shi, Tokyo, Japan
Pfizer Investigational Site	Recruiting
Setagaya-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A9451162
Study First Received:	January 16, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00603473
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Epilepsies, Partial
Excitatory Amino Acids
Calcium, Dietary
Gabapentin

Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 14, 2009