Epilepsies, PartialPhase 3NCT00620555

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

A Phase 3 study testing gabapentin in people with Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures Read more about this study

Who is it for?: Ages 3 years and older
Conditions the study is for: Epilepsies, Partial
What is being tested?: gabapentin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 22 sitesJapan
Study dates: May 2008to Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Completion of study A9451162 (NCT00603473)

Who cannot join

Seizures related to drugs or acute medical illness
History of any serious medical or psychiatric disorder

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Japan22 sites

Pfizer Investigational Site
Hiroshima
Pfizer Investigational Site
Izumi-shi, Osaka
Pfizer Investigational Site
Jonan-ku, Fukuoka
Pfizer Investigational Site
Kanazawa, Ishikawa-ken
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Kodaira, Tokyo
Pfizer Investigational Site
Kurashiki, Okayama Pref.
Pfizer Investigational Site
Miyakojima-ku, Osaka
Pfizer Investigational Site
Niigata, Niigata
Pfizer Investigational Site
Obu-shi,Morioka-machi, Aichi-ken
Pfizer Investigational Site
Okayama, Okayama-ken
Pfizer Investigational Site
Saitama
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Shinjuku-ku, Tokyo
Pfizer Investigational Site
Shizuoka, Shizuoka
Pfizer Investigational Site
Shōwaku, Nagoya
Pfizer Investigational Site
Suita, Osaka
Pfizer Investigational Site
Suma-Ku,Kobe, Hyōgo
Pfizer Investigational Site
Yamagata
Pfizer Investigational Site
Yokohama, Kanagawa Pref.
Pfizer Investigational Site
Zentsuuji, Kagawa-ken

Other trials in Japan

About this study

Official title: A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT00603473)

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

Conditions: Epilepsies, Partial
Being tested: gabapentin
Medical subject headings: Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gabapentinDrug
Orally administered gabapentin

Study groups in NCT00620555
Study group	Role	What they receive
gabapentin	Experimental	Not described Receives: Drug: gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
Measured: up to 53 weeks

Secondary outcomes (3)

Response Ratio
The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Measured: Up to 52 weeks
Responder Rate
Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Measured: Up to 52 weeks
Percent Change in Seizure Frequency
Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Dec 2010

First posted21 Feb 2008 (estimated)
Study startMay 2008
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Epilepsies, PartialStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00620555
Sponsor's protocol ID: A9451165
Status last verified: Nov 2011
First submitted: 11 Feb 2008
Last updated: 3 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures

All Epilepsies, Partial trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT00603473)
ClinicalTrials.gov ID: NCT00620555
Acronym / sponsor ID: A9451165
Conditions: Epilepsies, Partial
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 20 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
gabapentin	Experimental	Drug: gabapentin

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Completion of study A9451162 (NCT00603473)

Key exclusion criteria (2 listed)

Seizures related to drugs or acute medical illness
History of any serious medical or psychiatric disorder

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
gabapentinOrally administered gabapentin	Drug	gabapentin

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Time frame: up to 53 weeks
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.

3 secondary outcomes

Response Ratio
Time frame: Up to 52 weeks
Responder Rate
Time frame: Up to 52 weeks
Percent Change in Seizure Frequency
Time frame: Up to 52 weeks

Results and safety

Results posted to the registry on 20 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gabapentin	65	44

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)

Time frame: up to 53 weeks. Number. Unit: Participants

Measure	Gabapentin n = 65
All-causality adverse events (AEs)	58
Treatment-related AEs	13
All-causality serious AEs	2
Treatment-related serious AEs	0
All-causality severe AEs	1
Treatment-related severe AEs	0
Discontinuation due to all-causality AEs	4
Discontinuation due to treatment-related AEs	2

Population analysed: Safety analysis set: All paticipants who have received at least one dose of the study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gabapentin	2 of 65 (3.1%)	48 of 65 (73.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Epilepsies, Partial

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic 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.

Pfizer CT.gov Call Center study director

Pfizer

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gabapentin in people with Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Japan.

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 1 inclusion and 2 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) (time frame: up to 53 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620555.

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 3 Feb 2021.