Partial Seizures
Conditions
Keywords
Lyrica, Epilepsies - Partial
Brief summary
The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
Detailed description
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
Interventions
DRUGPregabalin
150 to 600 mg/day during 21 weeks
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
* Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.
Exclusion criteria
* Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase | Week 9 to Week 21 or End of Treatment (early termination) | 28-day seizure rate (at observation period \[obs\]) = \[(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 \[Week 9\] date)\] \* 28. Percent change = \[(28-day seizure rate obs minus 28-day seizure rate at baseline \[b\]) divided by 28-day seizure rate b\] \* 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21 | Week 21 or End of Treatment (early termination) | Percent change from Baseline = \[(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline \[b\]) divided by (28-day seizure rate b) \* 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency. |
| Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period | Week 9 to Week 21 or End of Treatment (early termination) | Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency. |
| Percent of Seizure- Free Participants During the Treatment Observation Period | Week 9 to Week 21 or Early Termination (end of treatment) | Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline). |
| Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period | Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) | Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline). |
| Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9) | — |
| Response Ratio (RR) | Week 9 to Week 21 or End of Treatment (early termination) | Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = \[(28-day seizure rate in observation period \[obs\] minus 28-day seizure rate at baseline \[b\] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)\] \* 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures. |
| Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21, LOCF | Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC. |
| Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21, LOCF | Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b. |
| Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale | Week 21, LOCF | Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline \[b\]) divided by MOS score b. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) | Week 21, LOCF | Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b. |
| Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) | — |
Countries
Mexico
Participant flow
Pre-assignment details
A total of 152 subjects were screened and 136 subjects were assigned to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin 150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability | 136 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 7 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| 28 day seizure frequency in Subjects with <= 6 and > 6 seizures during Baseline Period <=6 seizures | 2 seizures STANDARD_DEVIATION 0.8 |
| 28 day seizure frequency in Subjects with <= 6 and > 6 seizures during Baseline Period > 6 seizures | 12 seizures STANDARD_DEVIATION 17.2 |
| 28-Day Seizure Rate | 7.8 seizure rate STANDARD_DEVIATION 14 |
| Age, Customized 18 - 44 years | 107 participants |
| Age, Customized 45 - 64 years | 25 participants |
| Age, Customized >= 65 years | 4 participants |
| Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score | 8.8 score on scale STANDARD_DEVIATION 4.2 |
| Hospital Anxiety and Depression Scale (HADS) Depression Total Score | 7.3 score on scale STANDARD_DEVIATION 4.1 |
| Medical Outcomes Study Sleep Scale 9-Item Sleep Problems Index | 33.4 scores on scale STANDARD_DEVIATION 15.8 |
| Medical Outcomes Study Sleep Scale Awaken Short of Breath | 26.0 scores on scale STANDARD_DEVIATION 24.8 |
| Medical Outcomes Study Sleep Scale Optimal Sleep | 0.5 scores on scale STANDARD_DEVIATION 0.5 |
| Medical Outcomes Study Sleep Scale Quantity of Sleep | 7.9 scores on scale STANDARD_DEVIATION 1.9 |
| Medical Outcomes Study Sleep Scale Sleep Adequacy | 64.6 scores on scale STANDARD_DEVIATION 26.1 |
| Medical Outcomes Study Sleep Scale Sleep Disturbance | 32.9 scores on scale STANDARD_DEVIATION 20.9 |
| Medical Outcomes Study Sleep Scale Snoring | 40.1 scores on scale STANDARD_DEVIATION 33.4 |
| Medical Outcomes Study Sleep Scale Somnolence | 39.2 scores on scale STANDARD_DEVIATION 24.5 |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 91 / 136 |
| serious Total, serious adverse events | 8 / 136 |
Outcome results
Primary
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase
28-day seizure rate (at observation period \[obs\]) = \[(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 \[Week 9\] date)\] \* 28. Percent change = \[(28-day seizure rate obs minus 28-day seizure rate at baseline \[b\]) divided by 28-day seizure rate b\] \* 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.
Time frame: Week 9 to Week 21 or End of Treatment (early termination)
Population: Full Analysis Set (FAS): all subjects who received at least 1 dose of assigned treatment, had valid baseline seizure data, and had at least 1 subsequent rating of seizure frequency (modified intent to treat population). N=number of subjects with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase | -51.2 percent change | Standard Deviation 45.2 |
Comparison: Percent change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.
Time frame: Week 21, LOCF
Population: FAS. LOCF = Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) | Week 21: Anxiety | -1.4 scores on scale | Standard Deviation 3.7 |
| Pregabalin | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) | LOCF: Anxiety | -1.4 scores on scale | Standard Deviation 3.8 |
| Pregabalin | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) | Week 21: Depression | -0.8 scores on scale | Standard Deviation 4.8 |
| Pregabalin | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) | LOCF: Depression | -0.7 scores on scale | Standard Deviation 4.7 |
Comparison: Anxiety: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: <0.0001t-test, 2 sided
Comparison: Anxiety: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: <0.0001t-test, 2 sided
Comparison: Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.0799t-test, 2 sided
Comparison: Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.0846t-test, 2 sided
Secondary
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.
Time frame: Week 21, LOCF
Population: FAS. LOCF = Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21: Sleep Disturbance | -3.8 scores on scale | Standard Deviation 20.9 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | LOCF: Sleep Disturbance | -4.0 scores on scale | Standard Deviation 21.1 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21: Snoring | 1.4 scores on scale | Standard Deviation 35.4 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21: 9-Item Overall Sleep Problem Index | -2.2 scores on scale | Standard Deviation 16.6 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | LOCF: Snoring | 2.2 scores on scale | Standard Deviation 34.3 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21: Awaken Short of Breath | 0.7 scores on scale | Standard Deviation 32.4 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | LOCF: Awaken Short of Breath | 0.3 scores on scale | Standard Deviation 30.9 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21: Adequacy | 4.2 scores on scale | Standard Deviation 28 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | LOCF: Adequacy | 4.0 scores on scale | Standard Deviation 26.9 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21: Somnolence | 0.4 scores on scale | Standard Deviation 28.3 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | LOCF: Somnolence | -0.8 scores on scale | Standard Deviation 28.2 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | LOCF: 9-Item Overall Sleep Problem Index | -2.5 scores on scale | Standard Deviation 16.1 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | Week 21: Sleep Quantity | 0.4 scores on scale | Standard Deviation 2.1 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS) | LOCF: Sleep Quantity | 0.4 scores on scale | Standard Deviation 2.1 |
Comparison: Week 21: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.0552t-test, 2 sided
Comparison: LOCF: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.035t-test, 2 sided
Comparison: Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.6743t-test, 2 sided
Comparison: LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.4736t-test, 2 sided
Comparison: Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.8173t-test, 2 sided
Comparison: LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.9092t-test, 2 sided
Comparison: Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.1091t-test, 2 sided
Comparison: LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.0944t-test, 2 sided
Comparison: Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.8928t-test, 2 sided
Comparison: LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.7669t-test, 2 sided
Comparison: Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.1698t-test, 2 sided
Comparison: LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.0898t-test, 2 sided
Comparison: Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.0465t-test, 2 sided
Comparison: LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.0316t-test, 2 sided
Secondary
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale
Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline \[b\]) divided by MOS score b.
Time frame: Week 21, LOCF
Population: FAS. LOCF=Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale | Week 21 | 0.1 scores on scale | Standard Deviation 0.6 |
| Pregabalin | Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale | LOCF | 0.1 scores on scale | Standard Deviation 0.6 |
Comparison: Week 21; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.2187t-test, 2 sided
Comparison: LOCF; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: 0.1905t-test, 2 sided
Secondary
Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21
Percent change from Baseline = \[(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline \[b\]) divided by (28-day seizure rate b) \* 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.
Time frame: Week 21 or End of Treatment (early termination)
Population: FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21 | -36.0 percent change | Standard Deviation 55.8 |
Comparison: Percent change evaluated by a one-sample two-sided t-test comparing the difference to zero.p-value: <0.0001t-test, 2 sided
Secondary
Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period
Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.
Time frame: Week 9 to Week 21 or End of Treatment (early termination)
Population: FAS. N=number of subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period | <= 6 seizures at Baseline (n=50) | -57.9 percent change | Standard Deviation 44.9 |
| Pregabalin | Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period | > 6 seizures at Baseline (n=71) | -46.5 percent change | Standard Deviation 45.1 |
Comparison: Participants with \<= 6 seizures during Baseline period.p-value: <0.0001t-test, 2 sided
Comparison: Participants with \> 6 seizures during Baseline Period.p-value: <0.0001t-test, 2 sided
Secondary
Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
Time frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
Population: FAS. N=number of subjects with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | 63.6 percent of participants |
Secondary
Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
Time frame: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)
Population: FAS. N=number of subjects with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period | 48.8 percent of participants |
Secondary
Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period
Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).
Time frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
Population: FAS. N=number of subjects with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period | 40.5 percent of participants |
Secondary
Percent of Seizure- Free Participants During the Treatment Observation Period
Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).
Time frame: Week 9 to Week 21 or Early Termination (end of treatment)
Population: FAS. N=number of subjects with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percent of Seizure- Free Participants During the Treatment Observation Period | 20.7 percent of participants |
Secondary
Response Ratio (RR)
Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = \[(28-day seizure rate in observation period \[obs\] minus 28-day seizure rate at baseline \[b\] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)\] \* 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.
Time frame: Week 9 to Week 21 or End of Treatment (early termination)
Population: FAS. N=number of subjects with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Response Ratio (RR) | -45.1 ratio | Standard Deviation 37.9 |
p-value: <0.0001t-test, 2 sided
Secondary
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.
Time frame: Week 21, LOCF
Population: FAS. LOCF = Last Observation Carried Forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: Much Worse | 1.7 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: Very Much Worse | 0.9 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: Not Done | 2.6 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: Very Much Improved | 20.7 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: Much Improved | 51.1 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: Minimally Improved | 12.6 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: No Change | 4.4 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: Minimally Worse | 1.5 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: Much Worse | 1.5 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: Very Much Worse | 0.7 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | LOCF: Not Done | 7.4 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: Very Much Improved | 22.4 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: Much Improved | 52.6 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: Minimally Improved | 13.8 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: No Change | 4.3 percent of participants |
| Pregabalin | Treatment Satisfaction: Patient General Impression to Change (PGIC) | Week 21: Minimally Worse | 1.7 percent of participants |