Trial · NCT01262677
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in MOS-SS - Snoring 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 MOS-SS - Awaken Short of Breath or With Headache 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 MOS-SS - Quantity of Sleep (Hours) 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. | hours | MEAN |
| SECONDARY | Change From Baseline in MOS-SS - Sleep Adequacy 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 MOS-SS - Sleep Somnolence 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 MOS-SS - Sleep Problems Index I 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 Problems Index II 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 | Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale | 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 | Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question | 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 | BSW: Satisfaction From Treatment Question | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01262677/outcomes