primidone and Impotence

primidone has been researched along with Impotence in 1 studies

Primidone: A barbiturate derivative that acts as a GABA modulator and anti-epileptic agent. It is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite.
primidone : A pyrimidone that is dihydropyrimidine-4,6(1H,5H)-dione substituted by an ethyl and a phenyl group at position 5. It is used as an anticonvulsant for treatment of various types of seizures.

Research

Studies (1)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Change From Baseline in Adverse Event Profile (AEP) Score

Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. (NCT00522418)
Timeframe: Mean change from baseline AEP Score at 12 months

Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score

The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms. (NCT00522418)
Timeframe: Mean change from baseline CES-D Score at 12 months

Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms. (NCT00522418)
Timeframe: Mean change from baseline NDDI-E Score at 12 months

Changes in Anti-epileptic Drugs (AEDs)

Change from baseline in number of AED medications by visit (NCT00522418)
Timeframe: Change from baseline in number of AEDs at 12 months

Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months

The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00522418)
Timeframe: Mean change from baseline CGI-I Score at 12 months

Mean Percent Change in Seizure Frequency

Percent change in total seizuires per week from baseline at 12 months (NCT00522418)
Timeframe: Mean percent change from baseline in seizure frequency at 12 months

Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment

QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. (NCT00522418)
Timeframe: Mean change from baseline QOLIE-89 Overall Score at 12 months

Response Rate

Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period. (NCT00522418)
Timeframe: Number of Responders at 12 Months

Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40

QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. (NCT00522418)
Timeframe: Change from baseline up to 12 months

Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40

QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. (NCT00522418)
Timeframe: Change from baseline up to 12 months

Trials

1 trial available for primidone and Impotence