To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
482
150, 300, 450 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
300, 600, 1200, 2000 mg/day administered orally TID, until seizure control/improvement or intolerable side effects
Hospital Clinica Biblica
San José, Costa Rica
Instituto de Neurociencias
San Salvador, El Salvador
Clinica de Especialidades Neurologicas
San Salvador, El Salvador
Private Office
Guatemala Ciudad, Departamento de Guatemala, Guatemala
Percent Change From Baseline in 28-day Seizure Frequency at Week 21.
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure \[SGTC\]).
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline \<= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no).
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline \<= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC).
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Percentage of Participants Without Seizures.
Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
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Private Office
Guatemala City, Guatemala
Clinica Anglo Americana
Lima, Peru
Torre de Consultorios Clinica Anglo Americana
Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen - Essalud
Lima, Peru
Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.
Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.
SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate.
Time frame: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
Hospital Anxiety and Depression Scale (HADS) Score.
HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (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.
Time frame: Baseline, Week 21
Medical Outcomes Study Sleep Scale (MOS-SS) Score.
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range:0-100; higher score=more intensity of attribute.
Time frame: Baseline, Week 21
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.
Time frame: Baseline, Week 21