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Gabapentin

Phase 4FDA approved

Epilepsies, Partial | Small molecule | Neurology |Viatris Inc.|Trials Updated: Feb 3, 2021

Gabapentin development status

FDA approval on record Oct 9, 1998 as Neurontin
Approval holderViatris
ApplicationNDA020882
Highest phase Phase 4 (NCT00584779)
Phase scored for VTRSPhase 3
Registered trials 28 across 9 sponsors since Sep 2005

Label indication NEURONTIN ® is indicated for: • Management of postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy NEURONTIN is indicated for: • Postherpetic neuralgia in adults ( 1 ) • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary…

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials9
Total Enrollment6,015

FDA Designations

No designations recorded

Gabapentin clinical trials

Gabapentin · 9 trials · 2 indications

Phase 3 9
NCT00620555A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial SeizuresEpilepsies, Partial
COMPLETED65 Analytics
NCT00603473A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial SeizuresEpilepsies, Partial
COMPLETED92 Analytics
NCT00659100A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter EnvironmentTransient Insomnia
COMPLETED1,254 Analytics
NCT00674752A Polysomnographic Study Of Single-Dose Gabapentin In Transient InsomniaTransient Insomnia
COMPLETED377 Analytics
NCT00163046A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase AdvanceTransient Insomnia
COMPLETED256 Analytics
NCT00666575A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional SleeplessnessTransient Insomnia
COMPLETED2,105 Analytics
NCT00666770A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase AdvanceTransient Insomnia
COMPLETED309 Analytics
NCT00666939A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase AdvanceTransient Insomnia
COMPLETED773 Analytics
NCT00667108A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase AdvanceTransient Insomnia
COMPLETED784 Analytics
PHASE3COMPLETED
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Epilepsies, PartialUnlock trial analytics
PHASE3COMPLETED
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Epilepsies, PartialUnlock trial analytics
PHASE3COMPLETED
A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
Transient InsomniaUnlock trial analytics
PHASE3COMPLETED
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
Transient InsomniaUnlock trial analytics
PHASE3COMPLETED
A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Transient InsomniaUnlock trial analytics
PHASE3COMPLETED
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
Transient InsomniaUnlock trial analytics
PHASE3COMPLETED
A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Transient InsomniaUnlock trial analytics
PHASE3COMPLETED
A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance
Transient InsomniaUnlock trial analytics
PHASE3COMPLETED
A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Transient InsomniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
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.

Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
12 weeks

The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+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 12-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.

Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
Throughout Day 90
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
Throughout Day 90
Wake after sleep onset as measured by polysomnography (PSG)
Hour +8
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
Day 1
Adverse Events
Day 45
Latency to persistent sleep as measured by polysomnography
Hour +8
Subjective sleep latency
Hour +8

Secondary Endpoints

Response Ratio
Up to 52 weeks
Responder Rate
Up to 52 weeks
Percent Change in Seizure Frequency
Up to 52 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
gabapentinEXPERIMENTAL -
AEXPERIMENTAL -
BEXPERIMENTAL -
CPLACEBO_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Gabapentin 250 mgEXPERIMENTAL -
Gabapentin 500 mgEXPERIMENTAL -

Interventions

NameTypeDescription
gabapentinDRUGOrally administered gabapentin
PlaceboDRUGMatched placebo oral capsule 30 minutes prior to bedtime
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Eligibility Criteria

Age Range3 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Completion of study A9451162 (NCT00603473) Exclusion Criteria: * Seizures related to drugs or acute medical illness * History of any serious medical or psychiatric disorder

Countries:JapanUnited States
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