TerminatedPhase 3

Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS

Stopped: FDA placed a clinical hold on the Pediatric Program requiring retigabine discontinuation in subjects; early termination allows for timely reporting of results.

United States4 participantsStarted 2012-09-04

Plain-language summary

The purpose of this study is to evaluate the long-term safety and tolerability of retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset seizures (12 to \< 18 years old) or Lennox-Gastaut Syndrome (12 to \<30 years old) who have participated in a previous ("parent") study.

Who can participate

Age range12 Years – 29 Years

SexALL

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

Inclusion Criteria: * Has participated in either a Phase II or Phase III retigabine/ezogabine clinical trial evaluating partial onset seizures or seizures comprising Lennox-Gastaut syndrome and met the requirements defined in the parent study to transition into the open-label extension study * Investigator and caregiver consider it beneficial for the patient to continue treatment with retigabine/ezogabine * Female subjects of child-bearing potential (after menarche) must either not be sexually active or must be practicing an acceptable method of contraception (documented in the medical chart) from two weeks prior to administration of study medication and for 28 days after completion or premature discontinuation from the study * Subject is living with his/her custodial parent(s) or legal guardian(s) and has contact with them on a daily basis * Written informed consent is obtained from the subjects parent/guardian and accompanying assent from subject. The subject, and/or his/her custodial parents(s) or legal guardian(s) have the ability to comprehend the key components of the informed consent form Exclusion Criteria: * Has insufficient ability to articulate the presence or absence of urinary tract symptoms * Has experienced an adverse event, clinically significant laboratory abnormality or was discontinued from the parent study due to a reason that in the investigator's judgment would preclude enrollment to the study * Has a urine sample with: Urine specific gravity \>1.035,…

What they're measuring

Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period

Timeframe: From the start of study medication until the end of Follow-Up (up to 178 days)

Number of Participants With AEs Leading to Withdrawal

Timeframe: From the start of study medication until the end of the Follow-Up Visit (up to 178 days)

Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study

Timeframe: Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)

Change From Baseline in SBP and DBP at the Indicated Time Points

Timeframe: Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)

Change From Baseline in Heart Rate at the Indicated Time Points

Timeframe: Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)

Change From Baseline in Body Temperature at the Indicated Time Points

Timeframe: Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)

Trial details

NCT IDNCT01668654

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06-18

Results submitted2014-07-10

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