Phase 3
N=30
A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01777139 ↗Enrolled (actual)
30
Serious AEs
14.7%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs — 23; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Retigabine IR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs |
23; 5 | — |
| PRIMARY Percentage of Participants With TEAEs Leading to Study Discontinuation |
17 | — |
| PRIMARY Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs |
4; 9; 5; 5; 9; 5 | — |
| PRIMARY Number of Participants With PCC Values of Change From Baseline for Body Weight |
11; 4 | — |
| PRIMARY Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters |
1; 0; 1; 0; 5; 0 | — |
| PRIMARY Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) |
0.000; 0.000; 0.000; -0.003; 0.001; 0.003 | — |
| PRIMARY Change From Baseline in Hematocrit |
-0.0035; -0.0048; -0.0033; -0.0022; -0.0004; -0.0014 | — |
| PRIMARY Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) |
-2.6; -2.8; -2.2; -0.2; -0.8; -1.9 | — |
| PRIMARY Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level |
-0.30; -0.16; -0.23; -0.14; -0.46; -0.65 | — |
| PRIMARY Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) |
0.1; 0.4; 0.1; -0.7; -1.1; -1.2 | — |
| PRIMARY Change From Baseline in Red Blood Cell (RBC) Count |
-0.03; -0.06; -0.03; 0.01; 0.05; 0.04 | — |
| PRIMARY Change From Baseline in Red Cell Distribution Width (RDW) |
0.31; 0.43; 0.18; -0.33; -0.03; 0.01 | — |
| PRIMARY Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) |
0.8; 3.3; 0.3; 0.9; 0.6; 1.5 | — |
| PRIMARY Change From Baseline in Albumin and Total Protein |
-0.9; -0.3; -0.3; 0.1; -0.3; -1.1 | — |
| PRIMARY Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio |
4.2; 6.2; 7.0; 7.0; 18.11; 5.5 | — |
| PRIMARY Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN |
-0.015; -0.009; 0.017; 0.009; 0.020; -0.013 | — |
| PRIMARY Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid |
-2.18; -0.79; -0.35; -1.39; 0.32; 0.61 | — |
| PRIMARY Change From Baseline in Urine Albumin/Creatinine Ratio |
-0.05; 0.16; 1.51; -0.32; -0.26; 9.80 | — |
| PRIMARY Number of Participants With Abnormal Urinalysis Values (Categorical Data) |
2; 4; 4; 6; 1; 6 | — |
| PRIMARY Specific Gravity of Urine at Indicated Time Points |
1.0160; 1.0157; 1.0187; 1.0161; 1.0153; 1.0157 | — |
| PRIMARY Potential of Hydrogen (pH) of Urine at Indicated Time Points |
6.68; 6.48; 6.35; 6.39; 6.74; 6.40 | — |
| PRIMARY Change From Baseline in Urine Creatinine Concentration |
-1803.3; -1725.9; -508.0; -94.7; -58.8; -286.7 | — |
| PRIMARY Change From Baseline in American Urological Association (AUA) Symptom Scale Scores |
-0.5; 0.3; -0.3; -0.7; -2.0; -0.1 | — |
| PRIMARY Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes |
-3.4; 9.2; 2.0; 1.7; -8.0; -8.2 | — |
| PRIMARY Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) |
1; 0 | — |
| PRIMARY Number of Participants Who Discontinued From RTG |
0; 1; 1; 1; 1; 1 | — |
| PRIMARY Percentage of Participants With Retinal Pigmentary Abnormalities |
18 | — |
| PRIMARY Percentage of Participants With Pigmentation of Non-retinal Ocular Tissues |
32 | — |
| PRIMARY Percentage of Participants With Dermatologist-confirmed Abnormal Discoloration |
— | — |
| PRIMARY Percentage of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination |
16 | — |
| PRIMARY Percentage of Participants With Decrease in Confrontational Visual Field From Initial Examination |
21 | — |
| PRIMARY Percentage of Responders to POS Frequency |
23 | — |
| PRIMARY Percent Change From Baseline in 28-day Total POS Frequency |
-29.37 | — |
| PRIMARY Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of RTG |
0; 0 | — |
| PRIMARY Number of Participants With Resolution of Dermatologist-confirmed Abnormal Discoloration After Discontinuation of RTG |
— | — |
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).
Eligibility Criteria
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 pregnancy test at Screening.
- Is not pregnant or lactating or planning to become pregnant during the study.
Exclusion Criteria
- Has met any of the withdrawal criteria in the parent study (RTG114855) or has, in the opinion of the investigator, clinically significant abnormal laboratory or ECG findings that preclude entry into RTG114873.
- Is planning to begin treatment with an investigational drug (other than retigabine) and/or an experimental device for the treatment of epilepsy or any other medical condition.
- Has any medical condition that, in the investigator's judgement, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to clinically significant cardiac, renal, or hepatic condition; or a condition that affects the absorption, distribution, metabolism, or excretion of drugs.
- Is unwilling or unable to follow the study procedures or reporting of AEs.
- Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months or has history of suicide attempt in the last 2 years or >1 lifetime suicide attempt.
Data sourced from ClinicalTrials.gov (NCT01777139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.