carbamates and Migraine Disorders

carbamates has been researched along with Migraine Disorders in 12 studies

Migraine Disorders: A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

Research

Studies (12)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

"Number of Participants Who Were Much Improved or Very Much Improved (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17"

"The CGIC is a single question measured on a 7-point Likert Scale. (1 = very much improved; 2= much improved, and 7 = very much worse) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'." (NCT00742209)
Timeframe: Week 17

"Number of Participants Who Were Much Improved or Very Much Improved on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17"

"The PGIC is a single question measured on the 7-point Likert Scale (1 = very much improved; 2 = much improved; 7 = very much worse). A responder is defined as being very much improved or much improved." (NCT00742209)
Timeframe: Week 17

Adjusted Mean Change From Baseline in the Number of Migraine Attacks

A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper

A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Change From Baseline in the Mean Migraine Attack Duration

The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Change From Baseline in the Mean Peak Migraine Pain Severity

Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17

The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life. (NCT00742209)
Timeframe: Week 17

Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)

A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered

The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use

The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17

"Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale." (NCT00742209)
Timeframe: Week 17

Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17

The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status. (NCT00742209)
Timeframe: Baseline and Week 17

Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia

The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)

Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant. (NCT00742209)
Timeframe: Week 17

Mean Change From Baseline in the Number of MHD in All Study Phases

A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use

The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use

The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use

The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary. (NCT00742209)
Timeframe: Baseline and last 4 weeks of treatment prior to taper (up to Week 17)

Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods

A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures. (NCT00742209)
Timeframe: Baseline to the Last 4 weeks of treatment

Reviews

4 reviews available for carbamates and Migraine Disorders

Trials

2 trials available for carbamates and Migraine Disorders

Other Studies

6 other studies available for carbamates and Migraine Disorders