CompletedPhase 3

A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures

Malaysia, South Korea30 participantsStarted 2013-04-11

Plain-language summary

This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant partial-onset seizures (POS).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The subject has successfully completed the Maintenance Phase and Transition Phase of Study RTG114855. * The subject is expected, in the opinion of the investigator, to benefit from participation in this OLE study. * The subject or the caregiver is able and willing to maintain an accurate and complete written daily seizure calendar for the entire duration of the study. * The subject has given written informed consent, or has a legally authorized representative who has given written informed consent, prior to the performance of any study assessments. * A female subject is eligible to enrol and participate in the study if she is of: nonchildbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is premenarchal or postmenopausal), premenopausal females with a documented (medical report verification) hysterectomy with or without oophorectomy, or bilateral oophorectomy when reproductive status has been confirmed by hormone level assessment, and postmenopausal females defined as being amenorrhoeic for \>1 year with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). However, if indicated, this should be confirmed by oestradiol and follicle stimulating hormone levels consistent with menopause (according to local laboratory ranges). Women who have not been confirmed as postmenopausal should be advised to use contraception. * Childbearing potential, has a negative urine or serum pregna…

What they're measuring

Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs

Timeframe: Up to 4 years

Percentage of Participants With TEAEs Leading to Study Discontinuation

Timeframe: Up to 4 years

Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs

Timeframe: Baseline and up to 4 years

Number of Participants With PCC Values of Change From Baseline for Body Weight

Timeframe: Baseline and up to 4 years

Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters

Timeframe: Baseline and up to 4 years

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC)

Timeframe: Baseline and up to 4 years

Change From Baseline in Hematocrit

Timeframe: Baseline and up to 4 years

Trial details

NCT IDNCT01777139

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-14

Results submitted2017-11-27

View on ClinicalTrials.gov More Epilepsy trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs

Timeframe: Up to 4 years

Percentage of Participants With TEAEs Leading to Study Discontinuation

Timeframe: Up to 4 years

Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs

Timeframe: Baseline and up to 4 years

Number of Participants With PCC Values of Change From Baseline for Body Weight

Timeframe: Baseline and up to 4 years

Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters

Timeframe: Baseline and up to 4 years

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC)

Timeframe: Baseline and up to 4 years

Change From Baseline in Hematocrit

Timeframe: Baseline and up to 4 years