Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial

Browse trials for

• Seizures 881

Keywords

• Lyrica
• Epilepsies - Partial

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

This study's enrollment of 136 is above the median of 64 across 610 interventional studies indexed under Seizures.

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Study arms

• Experimental
  Pregabalin

  Drug: Pregabalin

Interventions

• DrugPregabalin

  150 to 600 mg/day during 21 weeks

Primary outcomes

1. Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase

   28-day seizure rate (at observation period \[obs\]) = \[(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 \[Week 9\] date)\] \* 28. Percent change = \[(28-day seizure rate obs minus 28-day seizure rate at baseline \[b\]) divided by 28-day seizure rate b\] \* 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.

   Time frame: Week 9 to Week 21 or End of Treatment (early termination)

Secondary outcomes

1. Response Ratio (RR)

   Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = \[(28-day seizure rate in observation period \[obs\] minus 28-day seizure rate at baseline \[b\] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)\] \* 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.

   Time frame: Week 9 to Week 21 or End of Treatment (early termination)

2. Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21

   Percent change from Baseline = \[(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline \[b\]) divided by (28-day seizure rate b) \* 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.

   Time frame: Week 21 or End of Treatment (early termination)

3. Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period

   Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.

   Time frame: Week 9 to Week 21 or End of Treatment (early termination)

4. Percent of Seizure- Free Participants During the Treatment Observation Period

   Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).

   Time frame: Week 9 to Week 21 or Early Termination (end of treatment)

5. Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period

   Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).

   Time frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)

6. Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period

   Time frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)

7. Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period

   Time frame: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)

8. Treatment Satisfaction: Patient General Impression to Change (PGIC)

   Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.

   Time frame: Week 21, LOCF

9. Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)

   Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.

   Time frame: Week 21, LOCF

10. Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale

    Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline \[b\]) divided by MOS score b.

    Time frame: Week 21, LOCF

11. Change From Baseline in Hospital Anxiety and Depression Scale (HADS)

    Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.

    Time frame: Week 21, LOCF

Baseline characteristics