Trial Outcomes & Findings for Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo (NCT NCT00351611)
NCT ID: NCT00351611
Last Updated: 2021-04-13
Results Overview
In this primary outcome measure, percentage of participants is reported, with a decrease in the threshold value from baseline to Week 12 or termination in any 5 or more points (in either eye) at the p\<0.05 level repeated in the same 5 points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard). It was derived from the Humphrey 24-2 SITA standard visual field analyzer. For each eye there were 52 test points. For each test point, the Humphrey analyzer determined the threshold value for sensitivity to light by the participant. In addition, for each of the 52 points, the test provided probabilities (p\<0.05, p\<0.02, etc.) that a participant with normal vision of the same age would have the same result, i.e., that the measured value at that point was at or below the respective percentile of the age-specific empiric distribution at that position of the field for normal participants.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
187 participants
Primary outcome timeframe
Baseline, Week 12 or Early Termination (any time up to Week 12)
Results posted on
2021-04-13
Participant Flow
Participant milestones
| Measure |
Pregabalin
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 milligram per day (mg/day) as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
98
|
|
Overall Study
Treated
|
89
|
98
|
|
Overall Study
COMPLETED
|
75
|
88
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
Pregabalin
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 milligram per day (mg/day) as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
No Longer Willing to Participate in Study
|
0
|
5
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo
Baseline characteristics by cohort
| Measure |
Pregabalin
n=89 Participants
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
n=98 Participants
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.1 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
39.1 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
38.6 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Others
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 or Early Termination (any time up to Week 12)Population: Per protocol population included all participants randomized to treatment who received at least 1 dose of study medication and excluded participants who had a decrease in at least 5 points at termination but did not return for a repeat test.
In this primary outcome measure, percentage of participants is reported, with a decrease in the threshold value from baseline to Week 12 or termination in any 5 or more points (in either eye) at the p\<0.05 level repeated in the same 5 points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard). It was derived from the Humphrey 24-2 SITA standard visual field analyzer. For each eye there were 52 test points. For each test point, the Humphrey analyzer determined the threshold value for sensitivity to light by the participant. In addition, for each of the 52 points, the test provided probabilities (p\<0.05, p\<0.02, etc.) that a participant with normal vision of the same age would have the same result, i.e., that the measured value at that point was at or below the respective percentile of the age-specific empiric distribution at that position of the field for normal participants.
Outcome measures
| Measure |
Pregabalin
n=78 Participants
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
n=90 Participants
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
|---|---|---|
|
Percentage of Participants With a Decrease (p<0.05) From Baseline in Threshold Value in Any 5 or More Points in Humphrey 24-2 Swedish Interactive Threshold Algorithm (SITA) Standard Testing at Week 12 or Early Termination
|
3.8 Percentage of participants
|
5.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12 or Early Termination (any time up to Week 12)Population: ITT population included all participants randomized to treatment, who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" refers to those participants who were evaluable for this outcome measure.
Mean deviation (MD) is a global index of visual field depression. The MD ranges from 0 decibels (no defect) to about -32 decibels (end-stage damage), higher scores indicate worse condition. It is derived from the Humphrey 24-2 SITA standard visual field analyzer. Change in mean deviation score from baseline to Week 12 or termination was computed for each participant. As planned, for each participant, the worst eye (eye with the greatest decrease in mean deviation) was used in the analysis and data is reported for same.
Outcome measures
| Measure |
Pregabalin
n=83 Participants
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
n=96 Participants
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
|---|---|---|
|
Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination
|
-0.339 Decibels
Standard Error 0.1467
|
-0.214 Decibels
Standard Error 0.1321
|
SECONDARY outcome
Timeframe: Baseline, Week 12 or Early Termination (any time up to Week 12)Population: ITT population included all participants randomized to treatment, who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" refers to those participants who were evaluable for this outcome measure.
Visual acuity best-corrected (with glasses or best possible glasses prescription) was measured using early treatment diabetic retinopathy study (ETDRS) charts. There were 2 ETDRS charts. The letters on chart A were read using the right eye and on chart B using the left eye. The participants started from the top of the chart to down. The participants read down the chart until they reached a row where a minimum of 3 letters on a line could not be read. The participants were scored by number of letters identified correctly. Range was from 0 to 70, with higher scores indicate better visual acuity. As planned, for each participant, the worst eye (eye with the greatest decrease in visual acuity) was used in the analysis and data is reported for same.
Outcome measures
| Measure |
Pregabalin
n=83 Participants
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
n=94 Participants
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
|---|---|---|
|
Change From Baseline in Visual Acuity at Week 12 or Early Termination
|
-1.890 Letters identified correctly
Standard Error 0.5515
|
-0.990 Letters identified correctly
Standard Error 0.5057
|
Adverse Events
Pregabalin
Serious events: 4 serious events
Other events: 33 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=89 participants at risk
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
n=98 participants at risk
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.1%
1/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
0.00%
0/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
1.1%
1/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
0.00%
0/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Nervous system disorders
Postictal state
|
1.1%
1/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
0.00%
0/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Nervous system disorders
Status epilepticus
|
1.1%
1/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
0.00%
0/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
1.0%
1/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Major depression
|
1.1%
1/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
0.00%
0/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
1.1%
1/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
0.00%
0/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.1%
1/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
0.00%
0/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Pregabalin
n=89 participants at risk
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
|
Placebo
n=98 participants at risk
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
|
|---|---|---|
|
General disorders
Fatigue
|
6.7%
6/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
3.1%
3/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Investigations
Weight increased
|
5.6%
5/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
2.0%
2/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
22.5%
20/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
3.1%
3/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
3.4%
3/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
5.1%
5/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
7.9%
7/89 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
3.1%
3/98 • Baseline up to Week 15
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER