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Merz Pharmaceuticals Announce Three Studies of NT-201 - (Botulinum neurotoxin type A Free From Complexing Proteins)

... the Toronto Western Spasmodic Torticollis Rating scale (TWSTRS). Adverse events (AEs) were also ... the Toronto Western Spasmodic Torticollis Rating scale (TWSTRS). Adverse events (AEs) were also ... were the Ashworth Scale, Disability Assessment scale (DAS), global assessments, and standard safety ...

Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms

... by the ADHD Rating Scale-IV (ADHD-RS-IV), a scale frequently used in ADHD clinical trials. In ... percent vs 32.0 percent; P< .001). The CGI-I scale is a standard assessment used to rate the ... temper were assessed in children on a four-point scale and a higher score indicated greater problems. ...

Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

... using an electronic diary: a numeric rating scale (NRS) for pain (scale 0-10); a dysmenorrhea pain ... (scale 0-3). The NRS is the pain assessment scale suggested by the National Institutes of Health ... the validated Composite Pelvic Signs and Symptoms scale (CPSSS), require additional dialogue with our ...

New Study Confirms That the Supports Intensity Scale Assessment is Effective in Measuring the Support Needs of People With Intellectual Disability and Making Funding Decisions

... /PRNewswire-USNewswire/ -- The Supports Intensity scale (SIS) assessment tool can effectively predict ... titled, " Efficacy of the Supports Intensity scale (SIS) to Predict Extraordinary Support Needs " is ... of this study is that the Supports Intensity scale measures something unique from measures of ...

Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial

... conducted at serial time points using the PEC scale over the first 4-hour post-dose time period, ... A Clinical Global Impression-Severity (CGI-S) scale rating of agitation was completed at baseline for ... to ensure comparability across groups. The CGI-S scale ranges from 1 (normal) to 7 (among the most ...

Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

... symptoms as measured by the Young Mania Ratings scale and the Hamilton Rating scale for Depression, compared to placebo the higher ... group (b) Positive and Negative Syndrome scale for Schizophrenia (PANSS) is a standard ...

Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific Meeting

... validity of the Gastrointestinal Symptom Rating scale (GSRS) in patients with celiac disease. The GSRS ... the first time the validity of the GSRS clinical scale has been studied in celiac disease to assess ... "Relevance of the Gastrointestinal Symptom Rating scale (GSRS) in Patients with Celiac Disease" (Poster ...

Addrenex Pharmaceuticals Announces Positive Phase III Clinical Results for Clonicel to Treat ADHD

... placebo on the primary endpoint, the ADHD Rating scale of 18 symptoms. Clonicel was also statistically ... by clinicians and parents, including a scale that assesses adrenergic dysregulation. The scale was designed by Joseph Horacek, M.D., a Charlotte ...

Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis

... and Symptoms Score (CPSSS), a validated 0-15 scale that assesses five components of endometriosis ... menstruation), a component of the CPSSS; 0-3 scale (0=absence of pain, 1=mild pain, 2=moderate pain, ... menstruation), a component of the CPSSS; 0-3 scale (0=absence of pain, 1=mild pain, 2=moderate ...

Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients

... conducted at serial time points using the PEC scale over the first 4-hour post-dose time period, with ... A Clinical Global Impression-Severity (CGI-S) scale rating of agitation was completed at baseline for ... ensure comparability across groups. The CGI-S scale ranges from 1 (normal) to 7 (among the most ...

Four Alzheimer's Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation

... approximately seven points on the ADAS-cog scale and 10 points on the ADCS-ADL scale. According ... to make significant investments in these large scale trials - which may or may not work. This was a ... PBT2 in this study warrant evaluation in larger scale clinical trials in Alzheimer's." A Phase IIb ...

Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder

... by the Montgomery-Asberg Depression Rating scale (MADRS). Gary S. Sachs, M.D., founder and ... the Montgomery-Asberg Depression Rating scale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C). Patients were evaluated at baseline ...

Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results

... stool consistency using the Bristol Stool Form scale (BSFS), and straining. Patient-reported outcomes ... of complete evacuation. Bristol Stool Form scale (BSFS): A seven-point scale measuring stool consistency. BSFS is a surrogate ...

Alseres Pharmaceuticals Announces 12 Month Interim Results from the Phase I/IIa Cethrin(R) Clinical Trial in Acute Spinal Cord Injury

... were enrolled in the trial. The ASIA Impairment scale is used to grade patients within five categories ... to walk with assistance. A component of this scale is the assessment of change in Motor Score. The ... muscle groups in each arm and leg on a 0-5 point scale for a total of 100 motor points. Using ...

Results of the Phase III Pivotal Study of VYVANSE(TM) (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults Presented at National Scientific Meeting of Psychiatrists

... provided a significant reduction in ADHD Rating scale (ADHD-RS-IV) scores within one week that were ... Clinical Global Impressions-Improvement (CGI-I) scale and found that the percentage of subjects taking ... the American Psychiatric Association. The CGI-I scale is a standard assessment used to rate the ...

New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months

... of DAYTRANA was measured using the ADHD Rating scale (ADHD-RS-IV), the Clinical Global Impressions-Improvement (CGI-I) scale and the Parent Global Assessment (PGA) rating scale and measurement results were found to be ...

Data Presented at the American Psychiatric Association (APA) Annual Meeting Demonstrate Iloperidone's Efficacy and Safety, With Low Rates of Movement and Metabolic Adverse Events

... (1) Positive and Negative Symptom scale Total (PANSS-T) (2) PANSS Negative (PANSS-N), ... Positive (PANSS-P) (3) Brief Psychiatric Rating scale (BPRS) (4) Clinical Global Impression Severity ... of Change (CGI-C) (6) Barnes Akathisia scale (BAS) (7) Extrapyramidal Symptom ...

New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting

... the change in Montgomery-Asberg Depression Rating scale (MADRS)* scores as the primary assessment of ... (Studies 9, 10 and 11) used the Hamilton Rating scale for Anxiety (HAM-A)(++) as the primary assessment ... construed as a profit forecast. (*) The MADRS scale measures the severity of a number of ...

Data Presented at the American Academy of Neurology Show XP13512/GSK1838262 Significantly Improved Symptoms of Moderate-to-Severe Primary Restless Legs Syndrome

... the International Restless Legs Syndrome (IRLS) scale total score and the proportion of ... the unadjusted mean change from baseline in IRLS scale total score at Week 12 was significantly greater ... was rated as responders on the CGI-I scale compared to placebo (38.9 percent; P<0.0001). ...

U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

... from baseline to Week 4 on the Young-Mania Rating scale (Y-MRS) Total Score. "We are pleased that the ... is a standard measure that is an 11-item rating scale used by healthcare providers to assess the scope ... RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity, and ...

Vanda Presents Phase III Iloperidone Efficacy Data

... akathisia versus placebo on the Barnes Akathisia scale (BAS), with 26 percent of patients experiencing a ... profile on the Extrapyramidal Symptoms Rating scale (ESRS) versus placebo. "Akathisia is a ... from baseline using the Brief Psychiatric Rating scale (BPRS) for the 1,553 patients who remained on ...

Research Identifies Need for Improved Understanding of Sickle Cell Disease in Adulthood

... below 86 on the Wechsler Adult Intelligence scale Performance IQ and Processing Speed Index scores, ... patients scored below 86 on the Wechsler Memory scale Visual Immediate and Immediate Memory scales, ... significantly on the Wechsler Adult Intelligence scale Processing Speed Index score and ...

New Analysis from 14 Countries Identifies Drug Access Priorities to Achieve 2010 AIDS Treatment Target

... 125 countries, today issued its fifth report on scale up of AIDS services: Missing the Target #5: ... AIDS drug access in 14 countries and finds that scale up is working but high prices, patent and ... delivery in their countries. "AIDS treatment scale up cannot succeed without stronger health ...

SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

... on 30-item Positive and Negative Syndrome scale (PANSS) scale. Each symptom was rated on a severity scale from 1-7. PANSS positive (7 items), negative (7 ... to evaluate patients. The Global Improvement scale involves the physician rating total ...

Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)

... This was assessed using a multidimensional scale for independence that was derived from validated ... were evaluated. After a final analysis, this scale was constructed of two factors: socio-emotional ... measuring independence using a multidimensional scale that included these two factors. Change in mean ...

Repligen Reports Positive Phase 2a Clinical Trial Results of RG2417 for Symptoms of Bipolar Disorder

... the Montgomery-Asberg Depression Rating scale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C). Patients were evaluated at baseline ... score as determined using the Young Mania Rating scale (YMRS) for mania (p=0.01), in the patients ...

INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients

... in the total Positive and Negative Syndrome scale (PANSS)(b) score over the first two weeks of the ... Audit). (b) Positive and Negative Syndrome scale for Schizophrenia (PANSS) is a standard rating scale used in trials to assess the severity of ....

Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome

... Restless Legs Syndrome Study Group Rating scale (IRLS) and a reduction in disease severity over a ... and the Restless Leg Syndrome-6 (RLS-6). The IRLS scale measures the severity and frequency of RLS ... symptoms and 40 = very severe symptoms). The CGI scale measures the general severity of an illness, ...

Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression

... of patient disability using a validated scale called EDSS (Expanded Disability Status ... A confirmed increase by one point in the EDSS scale can be an important and robust predictor of ... multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444-52. (2) Rio J, ...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

... endpoint of the study was to compare the change in the Hamilton Rating scale for Depression (HAMD-17) total score from baseline to the end of the study ... Severity (CGI-S) scale, the Montgomery Asberg Depression Rating scale (MADRS) total score and a Responder's Analysis showed statistical ...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

... catheter, subjects evaluated their pain using the Visual Analog pain scale (VAS) scoring system and were asked if they would use the IDDS again. ... subjects completing 8 minutes of treatment) the mean Visual Analog pain scale (VAS) results recorded by the subject following the venipuncture procedure ...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

... the three studies) and improvements in individual elements of the QOLIE-31 scale including seizure worry, emotional wellbeing, energy/fatigue, medication ... symptoms was also measured using the Montgomery Asberg Depression Rating scale (MADRS). During long-term, open-label therapy, ESL demonstrated a ...

Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

... in pain from baseline to endpoint based on the Pain Visual Analog scale (VAS). At three months, 54.2% (p<0.001) of patients treated with ... in sleep patterns compared to placebo as measured by the Jenkins Sleep scale (p<0.001). Statistically significant improvements in mean ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

... with greater improvement on both the Positive and Negative Syndrome scale (PANSS) total score (primary endpoint) and the Clinical Global Impressions Severity scale (CGI-S, key secondary endpoint) at all visits between weeks two and six. ...

FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia

... dose was superior to placebo in the Positive and Negative Syndrome scale (PANSS) total score. In a 6-week placebo-controlled trial (n=706) ... of Fanapt(TM) were superior to placebo on the Brief Psychiatric Rating scale (BPRS) total score. While it is not known how long patients treated ...

New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting

... the adjusted mean change in the Unified Parkinson's Disease Rating scale (UPDRS)* II+III score from baseline to week 18 was -5.1 points in the ... (or 35.7 percent). *The Unified Parkinson's Disease Rating scale (UPDRS) is a comprehensive tool, which was developed to follow the ...

Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients

... at 4 weeks using the Toronto Western Spasmodic Torticollis Rating scale (TWSTRS); adverse events (AEs) were also collected. The primary outcome ... Subjects were followed-up for up to 20 weeks. The Jankovic Rating scale (JRS) severity subscore six weeks after injection was the primary outcome ...

Study Demonstrates Restylane(R) Effect Lasted 18 Months in 97% of Patients With One Repeat Injection

... folds (NLF). Patients were evaluated using the Wrinkle Severity Rating scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe ...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

... mean change from baseline in the Unified Parkinson's Disease Rating scale (UPDRS)(2) Section III (motor) score during "ON" time and mean change in ... providing benefit. (2) The Unified Parkinson's Disease Rating scale (UPDRS) is one of the most widely used rating scales used to follow the ...

Sarah Cannon Research Institute Selects OmniComm Systems' Electronic Data Capture Solution, TrialMaster(TM), for Clinical Trials Management

... and support as well as the easy use of their EDC, which allows us to scale our business to meet the demands of our customers," said Phil Cestaro, ... pricing model allows companies that range from small to mid-size to large scale institutions to safely and efficiently capitalize on their clinical ...
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