A Phase 3 interventional study of Pregabalin Dose Level 1 and Pregabalin Dose Level 2 in Generalized Tonic Clonic Seizures, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 127 sites in 26 countries. Open to participants aged 5 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (part of Viatris Inc.) · Phase 3, Interventional, and Treatment
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's enrollment of 219 is above the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →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..
Counted across the registry records on this site, refreshed daily.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pregabalin Dose Level 1
Drug: Pregabalin Dose Level 2
Drug: Placebo
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Also known as: Lyrica Dose Level 1
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Also known as: Lyrica Dose Level 2
Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Time frame: Day 1 up to Week 12
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase
Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28.
Time frame: Day 1 up to Week 12
| Milestone | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo |
|---|---|---|---|
| Started | 75 | 72 | 72 |
| Completed | 60 | 61 | 66 |
| Not completed | 15 | 11 | 6 |
| Withdrew: Other | 1 | 1 | 1 |
| Withdrew: Adverse event | 8 | 5 | 2 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 4 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 1 |
All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
| Seizure per 28 days | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo |
|---|---|---|---|
| Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase | 1.17 ± 0.097 | 1.13 ± 0.095 | 1.14 ± 0.098 |
Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28.
| percentage of participants | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo |
|---|---|---|---|
| Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase | 41.3 | 38.9 | 41.7 |
Collected over Day 1 up to end of study (Week 13). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | 0/75 (0%) | 2/75 (2.7%) | 39/75 (52%) |
| Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | 0/72 (0%) | 2/72 (2.8%) | 41/72 (56.9%) |
| Placebo | 1/72 (1.4%) | 3/72 (4.2%) | 36/72 (50%) |
| Event | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo |
|---|---|---|---|
| Generalised tonic-clonic seizureNervous system disorders | 1/75 | 2/72 | 0/72 |
| SeizureNervous system disorders | 0/75 | 0/72 | 2/72 |
| Sudden unexplained death in epilepsyGeneral disorders | 0/75 | 0/72 | 1/72 |
| Status epilepticusNervous system disorders | 1/75 | 0/72 | 0/72 |
| Event | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo |
|---|---|---|---|
| DizzinessNervous system disorders | 13/75 | 12/72 | 5/72 |
| HeadacheNervous system disorders | 7/75 | 11/72 | 12/72 |
| SomnolenceNervous system disorders | 5/75 | 11/72 | 7/72 |
| Weight increasedInvestigations | 1/75 | 7/72 | 0/72 |
| FatigueGeneral disorders | 5/75 | 3/72 | 3/72 |
| Upper respiratory tract infectionInfections and infestations | 4/75 | 2/72 | 4/72 |
| FallInjury, poisoning and procedural complications | 1/75 | 2/72 | 3/72 |
| Increased appetiteMetabolism and nutrition disorders | 0/75 | 1/72 | 3/72 |
| VertigoEar and labyrinth disorders | 3/75 | 2/72 | 1/72 |
| NauseaGastrointestinal disorders | 2/75 | 2/72 | 1/72 |
Intent to treat (ITT) population included all randomized participants who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.
| Age, Continuous(years) | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| Mean | 24.0 ± 13.3 | 25.4 ± 12.7 | 26.2 ± 13.2 | 25.2 ± 13.1 |
| Sex: Female, Male(Participants) | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| Female | 42 | 39 | 40 | 121 |
| Male | 33 | 33 | 32 | 98 |
| Race (NIH/OMB)(Participants) | Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 8 | 8 | 6 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 67 | 64 | 65 | 196 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
Showing the first 100 of 127 sites across 26 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
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
Ran from Apr 2013 to primary completion in Feb 2019, 70 months.
Results were first posted in Aug 2019, 6 months after primary completion.
Of 43 industry-sponsored phase 3 interventional studies under Seizures, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 79. This study's 70 months is above that.
Counting every sponsor, half of 51 studies reached it within 54 months; a quarter within 33 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc. →