100 participants diagnosed with fibromyalgia according to ACR 1990 criteria.

Fibromyalgia

ACR 1990 fibromyalgia critters

BOR Physical medicine and rehabilitaton hospital

Estrogen Receptor 1 Gene Polymorphism Frequency in Fibromyalgia Syndrome

Investigation of Estrogen Receptor 1 Gene Polymorphism Frequency in Patients With Fibromyalgia Syndrome

The frequency of estrogen receptor alpha polymorphism in fibromyalgia and control group

Ercan KAYDOK

Assistant of Proffessor M.D. Ercan Kaydok

Nigde Omer Halisdemir University

Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).

Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).

Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.

Propranolol ER

Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules

Placebo

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Weekly mean pain intensity computed as the arithmetic mean of daily pain intensity values during the week prior to randomization. Daily pain intensity is measured on 0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") as reported in the Daily Symptom Diary. A higher score means a worse outcome.

Weekly Mean Pain Intensity

Weekly mean pain duration computed as the arithmetic mean of daily pain duration values during the week prior to randomization. Daily pain duration is measured on 0-100 percentage scale where percent = "percent of waking day you had facial pain" as reported in the Daily Symptom Diary. A higher score means a worse outcome.

Weekly Mean Pain Duration

Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary, divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome.

Weekly Mean Pain Index

The SF-McGill Pain Questionnaire contains 4 affective descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe."The item scores are summed to yield a total score with a range from 0 to 12. A higher score means a worse outcome.

The SF-McGill Pain Questionnaire Affective Component

The SF-McGill Pain Questionnaire contains 11 sensory descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe."The item scores are summed to yield a total score with a range form 0 to 33. A higher score means a worse outcome.

The SF-McGill Pain Questionnaire Sensory Component

Self-reported present intensity of facial pain at the moment of assessment scored on a descriptive scale where 1 = "no pain' and 6 = "excruciating pain." A higher score means worse outcome.

The SF-McGill Pain Questionnaire Present Facial Pain Intensity

Self-reported average facial pain intensity for the last week scored on 0-100 numerical rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable". A higher score means a worse outcome.

The SF-McGill Pain Questionnaire Weekly Average Facial Pain Intensity

Self-reported average facial pain duration for the last week scored on 0-100 percentage scale where percent = "percent of waking day you had facial pain." A higher score means a worse outcome.

The SF-McGill Pain Questionnaire Weekly Average Facial Pain Duration

Self-reported average fatigue for the last week scored on 0-100 numerical rating scale where 0 = "no fatigue" and 100 = "the greatest imaginable." A higher score means a worse outcome.

The SF-McGill Pain Questionnaire Weekly Fatigue

Individuals were classified into 6 chronic pain grades: 0 = no pain; I = low pain intensity and low pain-related disability; IIa = high pain intensity and low pain-related disability; IIb = high pain intensity and high activity interference; III = moderate pain-related disability; and IV = severe pain-related disability. For analyses, this variable was dichotomized: grades 0-IIa were combined in one category and all higher grades in another. A higher grade means a worse outcome.

Number of Participants Stratified per Graded Chronic Pain Scale (GCPS) grade

The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation." The Global Score is computed as the mean response for all items and ranges from 0 to 10. A higher score means a worse outcome.

The Jaw Functional Limitation Scale (JFLS) Global Score

The HIT-6 contains 6 items and assesses headache-related disability by the frequency of daily activity limitations ranging from "never" to "always." The 6 item scores are summed to yield a global score ranging from 36 to 78. A higher score means a worse outcome.

The Headache Impact Test (HIT-6) Global Score

The PSS assesses the frequency of 14 sources of stress on a scale from 0 = "never" to 4 = "very often." The item scores are summed to yield a Global Score ranging from 0 to 56. A higher score means a worse outcome.

The Perceived Stress Scale (PSS) Global Score

The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale, The 7 component scores are summed to yield a global PSQI score, which has a range of 0-21. A higher score means a worse outcome.

The Pittsburgh Sleep Quality Index (PSQI) Global Score

The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = "not at all" to 3 = "very often indeed". Responses are summed to provide separate scores for anxiety and depression (range from 0 to 21 for each subscale). A higher score means a worse outcome.

The Hospital Anxiety and Depression Scale (HADS) Anxiety Score

The Hospital Anxiety and Depression Scale (HADS) Depression Score

The SCL-90R Somatization Scale is a 12-item assessment of somatic symptom distress over the past 7 days rated from 0 = "not at all" to 4 = "extremely." The scale score is computed as the mean for all items. The score range is from 0 to 4. The higher score means a worse outcome.

The Symptom Checklist 90-Revised (SCL-90R) Somatization Scale Score

The SF-12v2 v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: "excellent" to "poor" (for general health); "yes, limited a lot" to "no, not limited at all" (for functional level); and "all of the time" to "none of the time" (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). The range for each component is 0-100 and a higher score means a better outcome.

The SF-12 Health Survey v2 (SF-12v2) Physical Component Summary (PCS)

The SF-12 Health Survey v2 (SF-12v2) Mental Component Summary (MCS)

Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli are averaged to measure the experimental thermal pain threshold (temperature at which pain is first perceived). The range was 32-50 degrees Celsius and a higher value means a better outcome.

Thermal Pain Threshold

Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli are averaged to measure the experimental thermal pain tolerance (temperature at which pain can no longer be tolerated). The range was 32-50 degrees Celsius and a higher value means a better outcome.

Thermal Pain Tolerance

Pressure values, measured in kiloPascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.

Pressure Pain Threshold at Temporalis Muscle

Pressure values, measured in kiloPascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.

Pressure Pain Threshold at Masseter Muscle

Pressure values, measured in kiloPascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporomandibular joint, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.

Pressure Pain Threshold at Temporomandibular Joint

Pressure values, measured in kiloPascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of trapezius muscle, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.

Pressure Pain Threshold at Trapezius Muscle

Pressure values, measured in kiloPascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of lateral epicondyle, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.

Pressure Pain Threshold at Lateral Epicondyle

Measured at TMD exam. A higher value means a better outcome.

Pain-free Jaw Opening

Maximum Unassisted Jaw Opening

Maximum Assisted Jaw Opening

Average of 3 repeated measures taken with a 2-minute interval.

Systolic Blood Pressure

Diastolic Blood pressure

Heart Rate

Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary and divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome.

Change in the Weekly Mean Pain Index After 9 Weeks of Treatment

Weekly mean pain intensity computed as the arithmetic mean of daily pain intensity values during the week prior to randomization and prior to each study visit. Daily pain intensity is measured on 0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") as reported in the Daily Symptom Diary. A higher score means a worse outcome.

Change in the Weekly Mean Pain Intensity After 9 Weeks of Treatment

Weekly mean pain duration computed as the arithmetic mean of daily pain duration values during the week prior to randomization and prior to each study visit. Daily pain duration is measured on 0-100 percentage scale where percent = "percent of waking day you had facial pain" as reported in the Daily Symptom Diary. A higher score means a worse outcome.

Change in the Weekly Mean Pain Duration After 9 Weeks of Treatment

The SF-McGill Pain Questionnaire contains 4 affective descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe." The item scores are summed to yield a total score ranging from 0 to 12. A higher score means a worse outcome.

Change in the SF-McGill Pain Questionnaire Affective Component After 9 Weeks of Treatment

The SF-McGill Pain Questionnaire contains 11 sensory descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe." The item scores are summed to yield a total score ranging from 0 to 33. A higher score means a worse outcome.

Change in the SF-McGill Pain Questionnaire Sensory Component After 9 Weeks of Treatment

Change in the SF-McGill Pain Questionnaire Present Facial Pain Intensity After 9 Weeks of Treatment

Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Intensity After 9 Weeks of Treatment

Self-reported average facial pain duration for the last week scored on 0-100 percentage scale where percent = "percent of waking day you had facial pain". A higher score means a worse outcome.

Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Duration After 9 Weeks of Treatment

Change in the SF-McGill Pain Questionnaire Weekly Fatigue After 9 Weeks of Treatment

Number of Participants Stratified Per Graded Chronic Pain Scale (GCPS) Grade After 9 Weeks of Treatment

Change in the Jaw Functional Limitation Scale (JFLS) Global Score After 9 Weeks of Treatment

Change in the Headache Impact Test (HIT-6) Global Score After 9 Weeks of Treatment

Change in the Pittsburgh Sleep Quality Index (PSQI) Global Score After 9 Weeks of Treatment

The PGIC scale assesses patient overall change in the severity of illness following treatment. Participants rate how they feel now compared with how they felt before receiving study drug on a 7-point scale where 0 = "No change or condition has got worse" and 6 = "A great deal better." A higher score means a better outcome. For analyses, this variable was dichotomized: scores from 0 to 3 were combined in one category of "No" (no significant improvement) and scores from 4 to 6 were combined in another category of "Yes" (significant improvement with the study treatment).

Number of Participants Stratified Per Dichotomized Score From the Patient Global Impression of Change (PGIC) Scale After 9 Weeks of Treatment

The PSS assesses the frequency of 14 sources of stress on a scale from 0 = "never" to 4 = "very often." The item scores are summed to yield a global score ranging from 0 to 56. A higher score means a worse outcome.

Change in the Perceived Stress Scale (PSS) Global Score After 9 Weeks of Treatment

The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = "not at all" to 3 = "very often indeed". Responses are summed to provide separate scores for anxiety and depression with a range from 0 to 21. A higher score means a worse outcome.

Change in the Hospital Anxiety and Depression Scale (HADS) Depression Score After 9 Weeks of Treatment

Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Score After 9 Weeks of Treatment

The SCL-90R Somatization Scale is a 12-item assessment of somatic symptom distress over the past 7 days rated from 0 = "not at all" to 4 = "extremely." The scale score is computed as the mean for all items. The score range is from 0 to 4. A higher score means a worse outcome.

Change in the Symptom Checklist 90-Revised (SCL-90R) Somatization Scale Score After 9 Weeks of Treatment

The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: "excellent" to "poor" (for general health); "yes, limited a lot" to "no, not limited at all" (for functional level); and "all of the time" to "none of the time" (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). summary (MCS). The range for each component is 0-100 and a higher score means a better outcome.

Change in the SF-12 Health Survey v2 (SF-12v2) Physical Component Summary (PCS) After 9 Weeks of Treatment

The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: "excellent" to "poor" (for general health); "yes, limited a lot" to "no, not limited at all" (for functional level); and "all of the time" to "none of the time" (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). The range for each component is 0-100 and a higher score means a better outcome.

Change in the SF-12 Health Survey v2 (SF-12v2) Mental Component Summary (MCS) After 9 Weeks of Treatment

Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli will be averaged to measure the experimental thermal pain threshold (temperature at which pain is first perceived). The range was 32-50 degrees Celsius and a higher value means a better outcome.

Change in Thermal Pain Threshold After 9 Weeks of Treatment

Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli will be averaged to measure the experimental thermal pain tolerance (temperature at which pain can no longer be tolerated). The range was 32-50 degrees Celsius and a higher value means a better outcome.

Change in Thermal Pain Tolerance After 9 Weeks of Treatment

Pressure values, measured in kilopascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.

Change in Pressure Pain Threshold at Temporalis Muscle After 9 Weeks of Treatment

Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.

Change in Pressure Pain Threshold at Masseter Muscle After 9 Weeks of Treatment

Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporomandibular joint, will be averaged to obtain a single pressure pain threshold value per anatomical site.

Change in Pressure Pain Threshold at Temporomandibular Joint After 9 Weeks of Treatment

Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of trapezius muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.

Change in Pressure Pain Threshold at Trapezius Muscle After 9 Weeks of Treatment

Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of lateral epicondyle, will be averaged to obtain a single pressure pain threshold value per anatomical site.

Change in Pressure Pain Threshold at Lateral Epicondyle After 9 Weeks of Treatment

Change in Pain-free Jaw Opening After 9 Weeks of Treatment

Change in Maximum Unassisted Jaw Opening After 9 Weeks of Treatment

Change in Maximum Assisted Jaw Opening After 9 Weeks of Treatment

Change in Systolic Blood Pressure After 9 Weeks of Treatment

Change in Diastolic Blood Pressure After 9 Weeks of Treatment

Change in Heart Rate After 9 Weeks of Treatment

Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary, divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome. The pain index was stratified per number of catechol-O-methyltransferase (COMT) Low Pain Sensitive (LPS) haplotypes.

Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT LPS Haplotypes

Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary, divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome. The pain index was stratified per number of catechol-O-methyltransferase (COMT) valine alleles at single nucleotide polymorphism (SNP) rs4680.

Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT Valine Alleles at rs4680

Overall Study

Dr. Inna E. Tchivileva

Temporomandibular Disorders

Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.

Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules

University of Florida-Gainesville College of Dentistry

University at Buffalo School of Dental Medicine

University of North Carolina at Chapel Hill School of Dentistry

Study of Orofacial Pain and PropRANOlol

Effect of COMT (Catecholamine-O-methyltransferase) Genetic Polymorphisms on Response to Propranolol Therapy in Temporomandibular Disorder

University of North Carolina, Chapel Hill

University of Florida

Rho, Inc.

National Institutes of Health (NIH)

National Institute of Dental and Craniofacial Research (NIDCR)

State University of New York at Buffalo

Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent

Multiple System Atrophy

EGCG as putative neuroprotective agent

Fox trial finder of the Michael J Fox foundation

Neurology Department, Ludwig-Maximilians University

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus für Bewegungsstörungen

Charité - Universitätsmedizin Berlin

Technische Universität Dresden

Heinrich-Heine-Universität, Neurologische Klinik

Paracelsus-Elena-Klinik Kassel

Universität Leipzig

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Philipps Universität Marburg

Eberhard Karls Universität Tübingen

Universitätsklinikum Ulm

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Double-blind, Randomised, Placebo-controlled Parallel Group Study to Investigate the Effect of EGCG Supplementation on Disease Progression of Patients With Multiple System Atrophy (MSA)

To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7, (80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3.9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo-treatment.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in UMSARS total score

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in clinical global impression

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral atrophy (3D MP-RAGE MRI volumetry, 3D FLAIR)

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral iron deposition in pons and striatum (T2* MRI)

Clinical safety and tolerability of EGCG (physical and neurological examination, laboratory parameters, adverse events, vital signs, drop-out rates, survival rates and survival time)

To assess any effect of EGCG vs. Placebo on the evolution of the above mentioned parameters during the wash-out phase (from V6 to V7) to explore possible symptomatic effects.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in Albumine, total protein, ferritin, iron, transferrin

catechol/cefalea

Estrogen Receptor 1 Gene Polymorphism Frequency in Fibromyalgia Syndrome

Study of Orofacial Pain and PropRANOlol

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

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