Epilepsy
Conditions
Brief summary
The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.
Interventions
150 mg up to a maximum of 600 mg per day bid or tid as required
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin * Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest
Exclusion criteria
* Is pregnant or is considering becoming pregnant during the course of the study * Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Year 5 and follow-up (30 days after last dose) | 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 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Seizures | Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose) | Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Other | 1 |
| Overall Study | Study Terminated by Sponsor | 18 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Continuous | 44.0 Years STANDARD_DEVIATION 12.6 |
| Mean Number of Seizures | 30.70 Seizures STANDARD_DEVIATION 40.63 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 21 |
| serious Total, serious adverse events | 3 / 21 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (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 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to Year 5 and follow-up (30 days after last dose)
Population: Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 21 Participants |
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 3 Participants |
Secondary
Mean Number of Seizures
Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.
Time frame: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)
Population: SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Number of Seizures | Month 24 to Month 30 (n = 18) | 32.50 Seizures | Standard Deviation 33.91 |
| Pregabalin | Mean Number of Seizures | Month 6 to Month 12 (n = 20) | 35.10 Seizures | Standard Deviation 46.92 |
| Pregabalin | Mean Number of Seizures | Month 12 to Month 18 (n = 18) | 29.70 Seizures | Standard Deviation 26.05 |
| Pregabalin | Mean Number of Seizures | Month 18 to Month 24 (n = 19) | 27.80 Seizures | Standard Deviation 28.75 |
| Pregabalin | Mean Number of Seizures | Month 30 to Month 36 (n = 18) | 29.30 Seizures | Standard Deviation 29.13 |
| Pregabalin | Mean Number of Seizures | Month 36 to Month 42 (n = 17) | 28.70 Seizures | Standard Deviation 28.38 |
| Pregabalin | Mean Number of Seizures | Month 42 to Month 48 (n = 11) | 24.80 Seizures | Standard Deviation 32.99 |
| Pregabalin | Mean Number of Seizures | Month 54 or EOS (n = 19) | 22.90 Seizures | Standard Deviation 24.57 |
| Pregabalin | Mean Number of Seizures | Follow-up (n = 14) | 6.40 Seizures | Standard Deviation 6.39 |