Epilepsy, Neuralgia
Conditions
Keywords
lyrica pregabalin epilepsy partial seizures
Brief summary
Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.
Detailed description
\- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).
Interventions
The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with partial seizures.
Exclusion criteria
* Contraindications according to Summary of Product Characteristics (SmPC).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency | Baseline through week 16 or early termination (ET) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit | Baseline and week 16 or ET | 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. |
| Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study | Week 4 through week 16 or ET | 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. |
| Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit | Baseline, week 4 and week 16 or ET | VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety). |
| Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Week 16 or ET | 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. |
| Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET | Baseline and week 16 or ET | 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. |
| Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Concomitant Drug Treatments | Baseline through Week 16 or ET | Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study. |
| Number of Participants With Concomitant Co-morbidities | Baseline through week 16 or ET | 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. |
Countries
Slovakia
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16. | 281 |
| Total | 281 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Insufficient clinical response | 1 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| 28-Day partial seizure frequency | 2.31 seizures STANDARD_DEVIATION 1.33 |
| Age, Continuous | 43.7 years STANDARD_DEVIATION 13.7 |
| Comorbidities in the past Alcohol abuse | 1 Participants |
| Comorbidities in the past Appendicectomy | 1 Participants |
| Comorbidities in the past Back pain | 1 Participants |
| Comorbidities in the past Brain contusion | 4 Participants |
| Comorbidities in the past Brain neoplasm | 2 Participants |
| Comorbidities in the past Central nervous system lesion | 1 Participants |
| Comorbidities in the past Cerebral hemorrhage | 1 Participants |
| Comorbidities in the past Cerebrovascular accident | 3 Participants |
| Comorbidities in the past Cholecystectomy | 1 Participants |
| Comorbidities in the past Concussion | 2 Participants |
| Comorbidities in the past Convulsion | 1 Participants |
| Comorbidities in the past Craniotomy | 1 Participants |
| Comorbidities in the past Delivery | 1 Participants |
| Comorbidities in the past Demyelination | 1 Participants |
| Comorbidities in the past Depression | 2 Participants |
| Comorbidities in the past Dyspepsia | 1 Participants |
| Comorbidities in the past Encephalitis | 3 Participants |
| Comorbidities in the past Encephalomalacia | 1 Participants |
| Comorbidities in the past Encephalopathy | 3 Participants |
| Comorbidities in the past Epilepsy | 1 Participants |
| Comorbidities in the past Extradural haematoma | 1 Participants |
| Comorbidities in the past Femur fracture | 1 Participants |
| Comorbidities in the past Gastric ulcer | 1 Participants |
| Comorbidities in the past Glaucoma surgery | 1 Participants |
| Comorbidities in the past Headache | 1 Participants |
| Comorbidities in the past Head injury | 2 Participants |
| Comorbidities in the past Hepatitis B surface antigen positive | 1 Participants |
| Comorbidities in the past Hepatitis non-A non-B | 1 Participants |
| Comorbidities in the past Hepatitis toxic | 1 Participants |
| Comorbidities in the past Herpes zoster | 1 Participants |
| Comorbidities in the past Hypercoagulation | 1 Participants |
| Comorbidities in the past Hypertension | 2 Participants |
| Comorbidities in the past Hypothyroidism | 1 Participants |
| Comorbidities in the past Hypotonia | 1 Participants |
| Comorbidities in the past Hypoxic encephalopathy | 1 Participants |
| Comorbidities in the past Hysterectomy | 1 Participants |
| Comorbidities in the past Ill-defined disorder | 4 Participants |
| Comorbidities in the past Inguinal hernia repair | 1 Participants |
| Comorbidities in the past Meningioma | 5 Participants |
| Comorbidities in the past Meningioma surgery | 1 Participants |
| Comorbidities in the past Meningitis | 1 Participants |
| Comorbidities in the past Muscle spasms | 1 Participants |
| Comorbidities in the past Neonatal asphyxia | 1 Participants |
| Comorbidities in the past Neuritis | 1 Participants |
| Comorbidities in the past Pleura carcinoma | 1 Participants |
| Comorbidities in the past Psychotic disorder | 1 Participants |
| Comorbidities in the past Pulmonary embolism | 1 Participants |
| Comorbidities in the past Pyrexia | 1 Participants |
| Comorbidities in the past Spinal anaesthesia | 1 Participants |
| Comorbidities in the past Spinal laminectomy | 1 Participants |
| Comorbidities in the past Strabismus correction | 1 Participants |
| Comorbidities in the past Subdural haematoma | 1 Participants |
| Comorbidities in the past Subdural haematoma evacuation | 1 Participants |
| Comorbidities in the past Transposition of great vessels | 1 Participants |
| Comorbidities in the past Traumatic brain injury | 5 Participants |
| Prior anti-epileptic medications Carbamazepine | 135 Participants |
| Prior anti-epileptic medications Cinolazepam | 1 Participants |
| Prior anti-epileptic medications Clonazepam | 7 Participants |
| Prior anti-epileptic medications Ergenyl chrono | 27 Participants |
| Prior anti-epileptic medications Gabapentin | 2 Participants |
| Prior anti-epileptic medications Lacosamide | 4 Participants |
| Prior anti-epileptic medications Lamotrigine | 57 Participants |
| Prior anti-epileptic medications Levetiracetam | 30 Participants |
| Prior anti-epileptic medications Oxcarbazepine | 12 Participants |
| Prior anti-epileptic medications Phenobarbital | 2 Participants |
| Prior anti-epileptic medications Phenytoin | 14 Participants |
| Prior anti-epileptic medications Pregabalin | 15 Participants |
| Prior anti-epileptic medications Primidone | 1 Participants |
| Prior anti-epileptic medications Sultiame | 1 Participants |
| Prior anti-epileptic medications Topiramate | 40 Participants |
| Prior anti-epileptic medications Valproate sodium | 24 Participants |
| Prior anti-epileptic medications Valproic acid | 66 Participants |
| Prior anti-epileptic medications Vigabatrin | 1 Participants |
| Prior anti-epileptic medications Zentronal | 1 Participants |
| Sex/Gender, Customized Female | 142 participants |
| Sex/Gender, Customized Male | 137 participants |
| Sex/Gender, Customized Unspecified | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 281 |
| serious Total, serious adverse events | 1 / 281 |
Outcome results
Primary
Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency | 85.00 Percentage of participants |
Secondary
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
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.
Time frame: Baseline and week 16 or ET
Population: The FAS included all participants who received at least 1 dose of the study drug and had at least one efficacy measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
| Pregabalin | 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 |
Secondary
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).
Time frame: Baseline, week 4 and week 16 or ET
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pregabalin | Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit | Baseline | 54.12 millimeter (mm) |
| Pregabalin | 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) |
| Pregabalin | 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) |
Secondary
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Not Assessed | 0 participants |
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Normal, not at all ill | 17 participants |
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Borderline ill | 25 participants |
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Mildly ill | 64 participants |
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Moderately ill | 118 participants |
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Markedly ill | 32 participants |
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Severely ill | 8 participants |
| Pregabalin | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Among the most extremely ill participants | 5 participants |
Secondary
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
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.
Time frame: Week 16 or ET
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Not Assessed | 0 Participants |
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Very much improved | 48 Participants |
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Much improved | 145 Participants |
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Minimally improved | 50 Participants |
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | No change | 29 Participants |
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Minimally worse | 0 Participants |
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Much worse | 1 Participants |
| Pregabalin | Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit | Very much worse | 0 Participants |
Secondary
Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study
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.
Time frame: Week 4 through week 16 or ET
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study | 172 Participants |
Secondary
Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit
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.
Time frame: Baseline and week 16 or ET
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit | -100.00 percent change |
p-value: <0.0001Signed Rank Test
Other Pre-specified
Number of Participants With Concomitant Co-morbidities
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.
Time frame: Baseline through week 16 or ET
Population: Safety analysis set included all enrolled participants who received 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Anaemia | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Thrombocytopenia | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Cardiomyopathy | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Coronary artery disease | 3 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Myocardial ischaemia | 4 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Sturge-Weber syndrome | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Deafness | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Hypoacusis | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Vertigo | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Autoimmune thyroiditis | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Endocrine disorder | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Goitre | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Hypothyroidism | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Reflux oesophagitis | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Hepatic fibrosis | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Liver disorder | 4 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Multiple allergies | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Seasonal allergy | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Neuroborreliosis | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Injury | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Diabetes mellitus | 6 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Hyperlipidemia | 2 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Obesity | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Type 1 diabetes mellitus | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Type 2 diabetes mellitus | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Mucoskeletal pain | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Osteoarthritis | 3 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Osteoporosis | 2 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Spinal disorder | 2 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Brain neoplasm malignant | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Oligodendroglioma | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Cerebral ischaemia | 2 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Cerebrovascular accident | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Dementia Alzheimer's type | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Dizziness | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Encephalopathy | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Grand mal convulsion | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Mental retardation | 3 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Migraine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Migraine without aura | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Neuropathy peripheral | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Polyneuropathy | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Anxiety | 6 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Anxiety disorder | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Depression | 11 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Generalised anxiety disorder | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Post-traumatic stress disorder | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Psychotic disorder due to medical condition | 4 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Nephropathy | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Asthma | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Chronic obstructive pulmonary disease | 2 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Hypertension | 28 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Post thrombotic syndrome | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Headache | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Hemiparesis | 1 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Schizophrenia | 2 participants |
| Pregabalin | Number of Participants With Concomitant Co-morbidities | Diabetic neuropathy | 1 participants |
Other Pre-specified
Number of Participants With Concomitant Drug Treatments
Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.
Time frame: Baseline through Week 16 or ET
Population: Safety analysis set included all enrolled participants who received 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Desloratadine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Acetylsalicylic acid | 8 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | All other therapeutic products | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Allopurinol | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Alprazolam | 4 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Aminophylline | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Amlodipine | 3 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Amlodipine Besilate | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Asasantin | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Atenolol | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Atorvastatin | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Baclofen | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Betahistine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Betahistine hydrochloride | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Betaxolol hydrochloride | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Biselect | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Bisoprolol | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Carbamazepine | 114 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Citalopram | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Clonazepam | 8 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Clopidogrel | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Clopidogrel sulfate | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Coversum combi | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Diazepam | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Diclofenac | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Digoxin | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Drug unspecified | 4 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Ergenyl chrono | 27 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Escitalopram | 3 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Fenofibrate | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Fentanyl | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Gabapentin | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Gingko biloba | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Gingko biloba extract | 5 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Gliclazide | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Hyzaar | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Ibuprofen | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Imidapril hydrochloride | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Insulin | 3 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Ipratropium bromide | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Lacosamide | 3 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Lamotrigine | 54 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Levetiracetam | 30 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Levothyroxine sodium | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Magnesium | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Metamizole sodium | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Metformin hydrochloride | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Molsidomine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Oxazepam | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Oxcarbazepine | 11 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Paracetamol | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Pentoxifylline | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Perindopril | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Perindopril arginine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Phenobarbital | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Phenytoin | 11 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Piracetam | 6 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Pregabalin | 66 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Primidone | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Ramipril | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Seretide mite | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Sertraline | 3 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Silymarin | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Sultiame | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Telmisartan | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Theophylline | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Thioctic acid | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Tianeptine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Tiapride | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Ticlopidine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Ticlopidine hydrochloride | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Tocopherol | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Topiramate | 34 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Tramadol | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Trandolapril | 3 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Trazodone hydrochloride | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Valproate sodium | 23 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Valproic acid | 55 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Venlafaxine | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Venlafaxine hydrochloride | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Verapamil hydrochloride | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Vinpocetine | 2 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Warfarin sodium | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Fluphenazine decanoate | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Folic acid | 1 participants |
| Pregabalin | Number of Participants With Concomitant Drug Treatments | Furosemide | 1 participants |