Trial · NCT01262677
Once-A-Day Pregabalin For Partial Seizures
NCT01262677, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2018-06-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Once-A-Day Pregabalin For Partial Seizures. Trials, record NCT01262677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01262677
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Once-A-Day Pregabalin For Partial Seizures
- NCT number
- NCT01262677
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 325 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Partial Seizures, Epilepsies, Partial
- Interventions
- pregabalin, pregabalin, pregabalin, pregabalin, pregabalin, pregabalin, placebo
- First posted
- 2010-12-17
- Last updated
- 2021-01-25
- Other registries' IDs
- eudract:2010-019035-35
- Results first posted
- 2018-06-06
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
| Secondary | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder. |
| Secondary | Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
| Secondary | Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. |
| Secondary | Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase | Week 2 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
| Secondary | Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase | Week 0 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. |
| Secondary | Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase | Week 2 to Week 14 | Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. |
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 | Baseline, Week 14 | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 | Baseline, Week 14 | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Secondary | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 | Baseline, Week 14 | Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range \* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Week 0 to Week 14 | The intent-to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | ln (seizures per 28 days) | MEAN |
| SECONDARY | Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Week 0 to Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | percentage of participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase | Week 0 to Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | ln (seizures per 28 days) | LEAST_SQUARES_MEAN |
| SECONDARY | Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase | Week 0 to Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | seizures per 28 days | MEAN |
| SECONDARY | Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase | Week 2 to Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | ln (seizures per 28 days) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase | Week 0 to Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | percentage of participants | NUMBER |
| SECONDARY | Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase | Week 2 to Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | ln(28-day seizure rate) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14 | Baseline, Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14 | Baseline, Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14 | Baseline, Week 14 | The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109. | units on a scale | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group414
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Pregabalin 165 mg | Baseline | 2.24 | Standard Deviation 0.757 | ln (seizures per 28 days) |
| Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Pregabalin 330 mg | Baseline | 2.33 | Standard Deviation 0.873 | ln (seizures per 28 days) |
| Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Placebo | Baseline | 2.32 | Standard Deviation 0.910 | ln (seizures per 28 days) |
| Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Pregabalin 165 mg | Week 14 | 1.84 | Standard Deviation 1.003 | ln (seizures per 28 days) |
| Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Pregabalin 330 mg | Week 14 | 1.80 | Standard Deviation 1.030 | ln (seizures per 28 days) |
| Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase | Placebo | Week 14 | 1.93 | Standard Deviation 1.132 | ln (seizures per 28 days) |
| Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Pregabalin 165 mg | Responder | 37.8 | percentage of participants | |
| Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Pregabalin 330 mg | Responder | 45.9 | percentage of participants | |
| Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Placebo | Responder | 35.8 | percentage of participants | |
| Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase | Pregabalin 165 mg | Non-responder | 62.2 | percentage of participants |
1 to 10 of 414Source ClinicalTrials.gov
See all 414 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin 165 mg | 100 | |
| Overall Study | STARTED | Pregabalin 330 mg | 113 | |
| Overall Study | STARTED | Placebo | 110 | |
| Overall Study | COMPLETED | Pregabalin 165 mg | 91 | |
| Overall Study | COMPLETED | Pregabalin 330 mg | 98 | |
| Overall Study | COMPLETED | Placebo | 98 | |
| Overall Study | NOT COMPLETED | Pregabalin 165 mg | 9 | |
| Overall Study | NOT COMPLETED | Pregabalin 330 mg | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Pregabalin 165 mg | 11 | 100 | |
| other | Dizziness | Nervous system disorders | Pregabalin 330 mg | 11 | 113 | |
| other | Dizziness | Nervous system disorders | Placebo | 2 | 110 | |
| other | Fatigue | General disorders | Pregabalin 165 mg | 3 | 100 | |
| other | Fatigue | General disorders | Pregabalin 330 mg | 6 | 113 | |
| other | Fatigue | General disorders | Placebo | 1 | 110 | |
| other | Weight increased | Investigations | Pregabalin 165 mg | 1 | 100 | |
| other | Weight increased | Investigations | Pregabalin 330 mg | 7 | 113 | |
| other | Weight increased | Investigations | Placebo | 0 | 110 | |
| serious | Bronchitis | Infections and infestations | Pregabalin 165 mg | 1 | 100 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin 165 mg | ||
| Total, all-cause mortality | Pregabalin 330 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin 165 mg | 14 | 100 |
| Total, other adverse events | Pregabalin 330 mg | 21 | 113 |
| Total, other adverse events | Placebo | 3 | 110 |
| Total, serious adverse events | Pregabalin 165 mg | 5 | 100 |
| Total, serious adverse events | Pregabalin 330 mg | 5 | 113 |
| Total, serious adverse events | Placebo | 2 | 110 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24962242 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01262677
GET https://conductscience.org/api/trials/v1/NCT01262677/registered?page=2