gamma-aminobutyric acid and Drug Refractory Epilepsy

gamma-aminobutyric acid has been researched along with Drug Refractory Epilepsy in 14 studies

gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.

Research

Studies (14)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

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]). (NCT00537940)
Timeframe: 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. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

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. (NCT00537940)
Timeframe: 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. (NCT00537940)
Timeframe: 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. (NCT00537940)
Timeframe: Baseline, Week 21

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). (NCT00537940)
Timeframe: 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). (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

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. (NCT00537940)
Timeframe: Baseline, Week 21

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. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks

Reviews

4 reviews available for gamma-aminobutyric acid and Drug Refractory Epilepsy

Trials

1 trial available for gamma-aminobutyric acid and Drug Refractory Epilepsy

Other Studies

9 other studies available for gamma-aminobutyric acid and Drug Refractory Epilepsy