A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

Browse trials for

• Epilepsy 1,848
• Seizures 766

Keywords

• safety
• partial onset seizures
• primary generalized tonic-clonic seizures
• pregabalin
• pediatric
• adult
• open-label
• long term

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's enrollment of 605 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 434 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

First submitted before Pfizer's Upjohn has merged with Mylan to form Viatris Inc. became part of Viatris Inc..

Study arms

• Experimental
  Open

  Pregabalin open label flexible dose

  Drug: Pregabalin

Interventions

• DrugPregabalin

  Pregabalin administered as either capsule or liquid oral formulations. Subjects \<4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.

  Also known as: Lyrica

Primary outcomes

1. Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.

   Time frame: Baseline (Day 1) up to 13 Months

2. Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months

   Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.

   Time frame: Baseline up to 12 Months

3. Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities

   Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) \>=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) \>=20 mmHg.

   Time frame: Baseline up to 12 months

4. Number of Participants With Tanner Staging Evaluation at Baseline

   Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

   Time frame: Baseline (Day 1)

5. Number of Participants With Tanner Staging Evaluation at Month 12

   Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

   Time frame: Month 12

6. Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months

   In this outcome measure number of participants with increase and decrease of \>=7% in body weight, from baseline up to 12 months are reported.

   Time frame: Baseline up to 12 Months

7. Absolute Values for Body Height at Baseline

   Time frame: Baseline

8. Absolute Values for Body Height at Month 12

   Time frame: Month 12

9. Number of Participants With Incidence of Laboratory Abnormalities

   Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: \<0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN/greater than (\>)1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil- absolute/%:\<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte- absolute/%:\>1.2\*ULN; total/direct/indirect bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN/\>1.2\*ULN; thyroxine, thyroid stimulating hormone \<0.8\*LLN/\>1.2\*ULN; cholesterol, triglycerides:\> \>1.3\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium: \<0.9\*LLN or \>1.1\*ULN; glucose \<0.6\*LLN/\>1.5\*ULN, creatine kinase\>2.0\*ULN; urine (specific gravity \<1.003/\>1.030, pH \<4.5/\>8, glucose, ketones, protein: \>=1, WBC, RBC:\>=20, bacteria \>20, hyaline casts/casts \>1); prothrombin (PT), PT international ratio\>1.1\*ULN.

   Time frame: Baseline up to 12 Months

10. Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters

    Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond \[msec\]) percent change (PctChg) \>=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg\>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change \>=30 to \<60; change \>=60. 'PctChg\>=25/50%': \>= 25% increase from baseline when baseline ECG parameter is \> 200 msec, and is \>= 50% increase from baseline when baseline ECG parameter is non-missing and \<=200 msec.

    Time frame: Baseline up to 12 Months

11. 28-Days Seizure Rate at Week 1

    28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

    Time frame: Week 1

12. 28-Days Seizure Rate at Month 1

    28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

    Time frame: Month 1

13. 28-Days Seizure Rate at Month 2

    28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

    Time frame: Month 2

14. 28-Days Seizure Rate at Month 4

    28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

    Time frame: Month 4

15. 28-Days Seizure Rate at Month 6

    28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

    Time frame: Month 6

16. 28-Days Seizure Rate at Month 9

    28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

    Time frame: Month 9

17. 28-Days Seizure Rate at Month 12/Early Termination

    28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

    Time frame: Month 12/Early Termination

Secondary outcomes

1. Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)

   Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with any methods (not plan) without intent to act", "active suicidal ideation with some intent to act, without specific plan", "active suicidal ideation with some intent to act, without specific plan".

   Time frame: Baseline (Day 1), Post-baseline on Day 1 up to 12 Months

2. Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)

   Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of "Yes" on "actual attempt"); (3) preparatory acts toward imminent suicidal behavior ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior").

   Time frame: Baseline (Day 1), Post-baseline up to 12 Months

3. Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task

   CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a "YES" response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI \<=-1.65, decline in cognition when RCI =\>1.65.

   Time frame: Month 12

4. Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task

   CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered "YES" if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by (\[square root 2\] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI \<=-1.65, decline in cognition: RCI =\>1.65.

   Time frame: Month 12

Baseline characteristics

Related links

• To obtain contact information for a study center near you, click here. ↗

Study documents

• Study protocol ↗ · May 7, 2014
• Statistical analysis plan ↗ · Sep 3, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Data sharing details ↗ · www.pfizer.com