Trial Outcomes & Findings for Clinical Study With Lyrica In Patients Suffering From Epilepsy (NCT NCT00922987)
NCT ID: NCT00922987
Last Updated: 2021-01-25
Results Overview
Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency \* 100, divided by the partial seizure frequency at the baseline visit.
Recruitment status
COMPLETED
Target enrollment
286 participants
Primary outcome timeframe
Baseline through week 16 or early termination (ET)
Results posted on
2021-01-25
Participant Flow
A total of 286 participants were assigned to treatment. At 1 of study sites, lack of archival of study files, source documentation, missing informed consent forms and large data discrepancies led to exclusion of all data from this site (N=5), as data could not be verified. Removal of these 5 participants did not change interpretation of results.
Participant milestones
| Measure |
Pregabalin
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Overall Study
STARTED
|
281
|
|
Overall Study
COMPLETED
|
277
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Pregabalin
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Overall Study
Insufficient clinical response
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Clinical Study With Lyrica In Patients Suffering From Epilepsy
Baseline characteristics by cohort
| Measure |
Pregabalin
n=281 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
137 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
142 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unspecified
|
2 participants
n=5 Participants
|
|
Comorbidities in the past
Hypercoagulation
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Transposition of great vessels
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Hypothyroidism
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Dyspepsia
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Gastric ulcer
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Ill-defined disorder
|
4 Participants
n=5 Participants
|
|
Comorbidities in the past
Pyrexia
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Hepatitis toxic
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Hepatitis non-A non-B
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Herpes zoster
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Meningitis
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Brain contusion
|
4 Participants
n=5 Participants
|
|
Comorbidities in the past
Concussion
|
2 Participants
n=5 Participants
|
|
Comorbidities in the past
Extradural haematoma
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Femur fracture
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Head injury
|
2 Participants
n=5 Participants
|
|
Comorbidities in the past
Subdural haematoma
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Traumatic brain injury
|
5 Participants
n=5 Participants
|
|
Comorbidities in the past
Hepatitis B surface antigen positive
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Back pain
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Muscle spasms
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Brain neoplasm
|
2 Participants
n=5 Participants
|
|
Comorbidities in the past
Meningioma
|
5 Participants
n=5 Participants
|
|
Comorbidities in the past
Pleura carcinoma
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Central nervous system lesion
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Cerebral hemorrhage
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Cerebrovascular accident
|
3 Participants
n=5 Participants
|
|
Comorbidities in the past
Convulsion
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Demyelination
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Encephalitis
|
3 Participants
n=5 Participants
|
|
Comorbidities in the past
Encephalomalacia
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Encephalopathy
|
3 Participants
n=5 Participants
|
|
Comorbidities in the past
Epilepsy
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Headache
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Hypotonia
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Hypoxic encephalopathy
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Neuritis
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Delivery
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Alcohol abuse
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Depression
|
2 Participants
n=5 Participants
|
|
Comorbidities in the past
Psychotic disorder
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Neonatal asphyxia
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Pulmonary embolism
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Appendicectomy
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Cholecystectomy
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Craniotomy
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Glaucoma surgery
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Hysterectomy
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Inguinal hernia repair
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Meningioma surgery
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Spinal anaesthesia
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Spinal laminectomy
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Strabismus correction
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Subdural haematoma evacuation
|
1 Participants
n=5 Participants
|
|
Comorbidities in the past
Hypertension
|
2 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Carbamazepine
|
135 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Cinolazepam
|
1 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Clonazepam
|
7 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Ergenyl chrono
|
27 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Gabapentin
|
2 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Lacosamide
|
4 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Lamotrigine
|
57 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Levetiracetam
|
30 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Oxcarbazepine
|
12 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Phenobarbital
|
2 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Phenytoin
|
14 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Pregabalin
|
15 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Primidone
|
1 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Sultiame
|
1 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Topiramate
|
40 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Valproate sodium
|
24 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Valproic acid
|
66 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Vigabatrin
|
1 Participants
n=5 Participants
|
|
Prior anti-epileptic medications
Zentronal
|
1 Participants
n=5 Participants
|
|
28-Day partial seizure frequency
|
2.31 seizures
STANDARD_DEVIATION 1.33 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through week 16 or early termination (ET)Population: The modified full analysis set (MFAS) included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis.
Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency \* 100, divided by the partial seizure frequency at the baseline visit.
Outcome measures
| Measure |
Pregabalin
n=260 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
|
85.00 Percentage of participants
Interval 80.66 to 89.34
|
SECONDARY outcome
Timeframe: Baseline and week 16 or ETPopulation: MFAS included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis. Analysis was done using last observation carried forward (LOCF) method.
The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit \* 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency\*100 divided by partial seizure frequency at baseline visit.
Outcome measures
| Measure |
Pregabalin
n=262 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit
|
-100.00 percent change
Interval -100.0 to -87.93
|
SECONDARY outcome
Timeframe: Week 4 through week 16 or ETPopulation: MFAS: Data collected during the titration phase, i.e. prior to Visit 2 (Week 4) were not analyzed for this endpoint. Only participants who did not discontinue in the first 4 weeks after the baseline visit (titration phase) and had at least 4 weeks of seizure data during the maintenance phase were analyzed for this endpoint.
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.
Outcome measures
| Measure |
Pregabalin
n=243 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study
|
172 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 4 and week 16 or ETPopulation: Full Analysis Set (FAS): Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. Analysis was done using LOCF method.
VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).
Outcome measures
| Measure |
Pregabalin
n=279 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
Change at Week 16 or ET
|
-26.16 millimeter (mm)
Interval -28.73 to -23.59
|
|
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
Baseline
|
54.12 millimeter (mm)
Interval 51.32 to 56.92
|
|
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
Change at Week 4
|
-13.60 millimeter (mm)
Interval -15.37 to -11.84
|
SECONDARY outcome
Timeframe: BaselinePopulation: FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Outcome measures
| Measure |
Pregabalin
n=269 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Not Assessed
|
0 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Normal, not at all ill
|
17 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Among the most extremely ill participants
|
5 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Borderline ill
|
25 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Mildly ill
|
64 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Moderately ill
|
118 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Markedly ill
|
32 participants
|
|
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Severely ill
|
8 participants
|
SECONDARY outcome
Timeframe: Week 16 or ETPopulation: FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.
The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C). At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.
Outcome measures
| Measure |
Pregabalin
n=273 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Minimally improved
|
50 Participants
|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
No change
|
29 Participants
|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Much worse
|
1 Participants
|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Not Assessed
|
0 Participants
|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Very much improved
|
48 Participants
|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Much improved
|
145 Participants
|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Minimally worse
|
0 Participants
|
|
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 16 or ETPopulation: The FAS included all participants who received at least 1 dose of the study drug and had at least one efficacy measurement.
MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.
Outcome measures
| Measure |
Pregabalin
n=281 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Sleep Problems Index II
|
44.55 Units on a scale
Standard Deviation 18.59
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Sleep Problems Index I
|
44.72 Units on a scale
Standard Deviation 18.61
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Sleep Disturbance
|
44.31 Units on a scale
Standard Deviation 22.44
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Snoring
|
33.71 Units on a scale
Standard Deviation 26.19
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Awaken Short of Breath
|
34.41 Units on a scale
Standard Deviation 26.45
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Quantity of Sleep (hours)
|
6.77 Units on a scale
Standard Deviation 1.23
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Sleep Adequacy
|
45.50 Units on a scale
Standard Deviation 22.12
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Baseline: Somnolence
|
37.19 Units on a scale
Standard Deviation 20.58
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Sleep Problems Index I
|
-16.93 Units on a scale
Standard Deviation 18.52
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Sleep Problems Index II
|
-19.44 Units on a scale
Standard Deviation 17.27
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Sleep Disturbance
|
-25.04 Units on a scale
Standard Deviation 19.49
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Snoring
|
-10.14 Units on a scale
Standard Deviation 18.88
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Awaken Short of Breath
|
-16.55 Units on a scale
Standard Deviation 24.26
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Quantity of Sleep (hours)
|
0.92 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Sleep Adequacy
|
9.27 Units on a scale
Standard Deviation 29.76
|
|
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Change at Week 16: Somnolence
|
-17.72 Units on a scale
Standard Deviation 16.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 16 or ETPopulation: Safety analysis set included all enrolled participants who received 1 dose of study medication.
Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.
Outcome measures
| Measure |
Pregabalin
n=281 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Number of Participants With Concomitant Drug Treatments
Gliclazide
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Hyzaar
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Ibuprofen
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Imidapril hydrochloride
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Insulin
|
3 participants
|
|
Number of Participants With Concomitant Drug Treatments
Ipratropium bromide
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Ticlopidine hydrochloride
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Tocopherol
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Topiramate
|
34 participants
|
|
Number of Participants With Concomitant Drug Treatments
Tramadol
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Acetylsalicylic acid
|
8 participants
|
|
Number of Participants With Concomitant Drug Treatments
All other therapeutic products
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Allopurinol
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Alprazolam
|
4 participants
|
|
Number of Participants With Concomitant Drug Treatments
Aminophylline
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Amlodipine
|
3 participants
|
|
Number of Participants With Concomitant Drug Treatments
Amlodipine Besilate
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Asasantin
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Atenolol
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Atorvastatin
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Baclofen
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Betahistine
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Betahistine hydrochloride
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Betaxolol hydrochloride
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Biselect
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Bisoprolol
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Carbamazepine
|
114 participants
|
|
Number of Participants With Concomitant Drug Treatments
Citalopram
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Clonazepam
|
8 participants
|
|
Number of Participants With Concomitant Drug Treatments
Clopidogrel
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Clopidogrel sulfate
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Coversum combi
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Desloratadine
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Diazepam
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Diclofenac
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Digoxin
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Drug unspecified
|
4 participants
|
|
Number of Participants With Concomitant Drug Treatments
Ergenyl chrono
|
27 participants
|
|
Number of Participants With Concomitant Drug Treatments
Escitalopram
|
3 participants
|
|
Number of Participants With Concomitant Drug Treatments
Fenofibrate
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Fentanyl
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Fluphenazine decanoate
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Folic acid
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Furosemide
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Gabapentin
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Gingko biloba
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Gingko biloba extract
|
5 participants
|
|
Number of Participants With Concomitant Drug Treatments
Lacosamide
|
3 participants
|
|
Number of Participants With Concomitant Drug Treatments
Lamotrigine
|
54 participants
|
|
Number of Participants With Concomitant Drug Treatments
Levetiracetam
|
30 participants
|
|
Number of Participants With Concomitant Drug Treatments
Levothyroxine sodium
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Magnesium
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Metamizole sodium
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Metformin hydrochloride
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Molsidomine
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Oxazepam
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Oxcarbazepine
|
11 participants
|
|
Number of Participants With Concomitant Drug Treatments
Paracetamol
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Pentoxifylline
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Perindopril
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Perindopril arginine
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Phenobarbital
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Phenytoin
|
11 participants
|
|
Number of Participants With Concomitant Drug Treatments
Piracetam
|
6 participants
|
|
Number of Participants With Concomitant Drug Treatments
Pregabalin
|
66 participants
|
|
Number of Participants With Concomitant Drug Treatments
Primidone
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Ramipril
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Seretide mite
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Sertraline
|
3 participants
|
|
Number of Participants With Concomitant Drug Treatments
Silymarin
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Sultiame
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Telmisartan
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Theophylline
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Thioctic acid
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Tianeptine
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Tiapride
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Ticlopidine
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Trandolapril
|
3 participants
|
|
Number of Participants With Concomitant Drug Treatments
Trazodone hydrochloride
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Valproate sodium
|
23 participants
|
|
Number of Participants With Concomitant Drug Treatments
Valproic acid
|
55 participants
|
|
Number of Participants With Concomitant Drug Treatments
Venlafaxine
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Venlafaxine hydrochloride
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Verapamil hydrochloride
|
1 participants
|
|
Number of Participants With Concomitant Drug Treatments
Vinpocetine
|
2 participants
|
|
Number of Participants With Concomitant Drug Treatments
Warfarin sodium
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through week 16 or ETPopulation: Safety analysis set included all enrolled participants who received 1 dose of study medication.
Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.
Outcome measures
| Measure |
Pregabalin
n=281 Participants
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Number of Participants With Concomitant Co-morbidities
Type 2 diabetes mellitus
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Mucoskeletal pain
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Schizophrenia
|
2 participants
|
|
Number of Participants With Concomitant Co-morbidities
Diabetic neuropathy
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Nephropathy
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Hypertension
|
28 participants
|
|
Number of Participants With Concomitant Co-morbidities
Anaemia
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Thrombocytopenia
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Cardiomyopathy
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Coronary artery disease
|
3 participants
|
|
Number of Participants With Concomitant Co-morbidities
Myocardial ischaemia
|
4 participants
|
|
Number of Participants With Concomitant Co-morbidities
Sturge-Weber syndrome
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Deafness
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Hypoacusis
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Vertigo
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Autoimmune thyroiditis
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Endocrine disorder
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Goitre
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Hypothyroidism
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Reflux oesophagitis
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Hepatic fibrosis
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Liver disorder
|
4 participants
|
|
Number of Participants With Concomitant Co-morbidities
Multiple allergies
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Seasonal allergy
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Neuroborreliosis
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Injury
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Diabetes mellitus
|
6 participants
|
|
Number of Participants With Concomitant Co-morbidities
Hyperlipidemia
|
2 participants
|
|
Number of Participants With Concomitant Co-morbidities
Obesity
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Type 1 diabetes mellitus
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Osteoarthritis
|
3 participants
|
|
Number of Participants With Concomitant Co-morbidities
Osteoporosis
|
2 participants
|
|
Number of Participants With Concomitant Co-morbidities
Spinal disorder
|
2 participants
|
|
Number of Participants With Concomitant Co-morbidities
Brain neoplasm malignant
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Oligodendroglioma
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Cerebral ischaemia
|
2 participants
|
|
Number of Participants With Concomitant Co-morbidities
Cerebrovascular accident
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Dementia Alzheimer's type
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Dizziness
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Encephalopathy
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Grand mal convulsion
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Headache
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Hemiparesis
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Mental retardation
|
3 participants
|
|
Number of Participants With Concomitant Co-morbidities
Migraine
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Migraine without aura
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Neuropathy peripheral
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Polyneuropathy
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Anxiety
|
6 participants
|
|
Number of Participants With Concomitant Co-morbidities
Anxiety disorder
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Depression
|
11 participants
|
|
Number of Participants With Concomitant Co-morbidities
Generalised anxiety disorder
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Post-traumatic stress disorder
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Psychotic disorder due to medical condition
|
4 participants
|
|
Number of Participants With Concomitant Co-morbidities
Asthma
|
1 participants
|
|
Number of Participants With Concomitant Co-morbidities
Chronic obstructive pulmonary disease
|
2 participants
|
|
Number of Participants With Concomitant Co-morbidities
Post thrombotic syndrome
|
1 participants
|
Adverse Events
Pregabalin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=281 participants at risk
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.36%
1/281 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Pregabalin
n=281 participants at risk
Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
|
|---|---|
|
Investigations
Weight increased
|
1.4%
4/281 • Number of events 4
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.36%
1/281 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
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