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Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
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The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.
Condition | Intervention | Phase |
Restless Legs Syndrome |
Drug: Rotigotine Nasal Spray Other: Placebo Nasal Spray |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Trial to Assess the Efficacy, Safety and Tolerability of Ascending Doses of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms in Subjects With Idiopathic Restless Legs Syndrome |
- Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo [ Time Frame: 4 hours post-treatment period at each treatment day ] [ Designated as safety issue: No ]Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.
- Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo. [ Time Frame: 4 hours post-treatment period at each treatment day ] [ Designated as safety issue: No ]The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.
Enrollment: | 44 |
Study Start Date: | August 2006 |
Study Completion Date: | December 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Placebo Comparator: Placebo
Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
Other: Placebo Nasal Spray
Daily single dose of placebo delivered as single puff of nasal spray solution
Experimental: Rotigotine Nasal Spray
Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
Drug: Rotigotine Nasal Spray
Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
Other Name: SPM937
Detailed Description:
Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale.
In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment
Exclusion Criteria:
- Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded
Additional Information:
No publications provided
Responsible Party: | UCB, Inc. |
ClinicalTrials.gov Identifier: | NCT00389831 History of Changes |
Other Study ID Numbers: | SP879 |
Study First Received: | October 17, 2006 |
Results First Received: | July 28, 2009 |
Last Updated: | August 30, 2011 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by UCB, Inc.:
Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Restless Legs Syndrome |
Additional relevant MeSH terms:
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations |
Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms N 0437 Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 11, 2014


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2008 Summer Session RegistrationContinuing Students
New and Returning Students
High School Contract Students
Late Registration
* Students must be registered by the end of the second day of the term for any six-week class. An add code (issued by the instructor) is required to register for any closed (full) class.
Download the 2008 Summer Session Registration Schedule 2008 Summer Session Academic Calendar |

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Policy WorkEqual@work initiative
ENAR's Equal@work Initiative (previously known as the Ad Hoc Expert Group on Promoting Equality in Employment) is a pioneering initiative, launched in 2009, bringing together businesses committed to diversity and inclusion, anti-racist civil society and other relevant stakeholders to find solutions to ensure the full participation of ethnic minorities in the labour market. It also enables the sharing of best practices and initiatives promoting equality in employment that have been undertaken by private companies, trade unions and governments.
The added value of the ENAR Equal@work initiative is the creation of a multi-stakeholder dialogue, which broadens our respective horizons, generates trust and inspires innovation.
Watch a short video of the Employment Conference in June 2011, with interviews with participants:


text:
NEW YORK (AP) - The stock market had its biggest drop in two months on Monday, led by a decline in energy stocks as the price of crude oil slumped. The retreat continued a weak start to the year on the U.S. stock market.
WASHINGTON (AP) - Senate Republicans and Democrats are squabbling publicly over legislation to resurrect federal unemployment benefits, at the same time they privately discuss possible steps toward compromise.
A Southwest Airlines flight bound for the main airport in Branson, Mo., instead touched down at a much smaller nearby airfield that gave the pilots only half as much room to stop.
NEW YORK (AP) - Target's pre-Christmas security breach was significantly more extensive and affected millions more shoppers than the company reported last month.
WASHINGTON (AP) - In a move that some fear could compromise care for Medicare recipients, the Obama administration is proposing to remove special protections that guarantee seniors access to a wide selection of three types of drugs.
ALTOONA, Pa. (AP) - Authorities say a man stole 12 bottles of hand sanitizer from a central Pennsylvania hospital so he could mix it with orange juice and drink it for the alcohol it contained.
RICHMOND, Va. (AP) - The nation's tobacco companies and the Justice Department have reached an agreement on publishing corrective statements that say the companies lied about the dangers of smoking and requires them to disclose smoking's health effects.
WASHINGTON (AP) - U.S. employers added a scant 74,000 jobs in December, the fewest in three years. The disappointing figure ends 2013 on a weak note and raises questions about whether the job market can sustain its recent gains.
WASHINGTON (AP) - Students at the U.S. military academies often believe they have to put up with sexist and offensive behavior, a Pentagon report finds, reflecting a culture of disrespect that permeates the schools and their sports teams and fuels reports of sexual harassment and assaults.
SAVANNAH, Ga. (AP) - Organizers of Savannah's St. Patrick's Day Parade say they've banned a firefighters' group from participating.
WASHINGTON (AP) - Republicans controlling the House are moving to take the roughest edges off across-the-board spending cuts that are just starting to take effect.
NEW YORK (AP) - Eight years after Martha Stewart was released from prison for lying about a stock trade, the home diva is now facing another legal mess that may not be easy to clean up.
NEW YORK (AP) - The Dow has never been higher.
ATLANTA (AP) - Atlanta public schools officials are considering ending a cell phone ban for younger students so they would be able to contact their parents in case of an emergency.
JERUSALEM (AP) - Israelis can now read Playboy 'for the articles' as a Hebrew language edition came to the holy land Tuesday.
WASHINGTON (AP) - U.S. home prices jumped in January, a sign the housing market is gaining momentum as it nears the spring selling season.
CHICAGO (AP) - Eight former Drug Enforcement Administration chiefs say the federal government needs to act now or it might lose the chance to nullify Colorado and Washington's laws legalizing recreational marijuana use.
MACON, Ga. (AP) - Students planning to attend college in Georgia and apply for state financial aid will soon have to fill out a federal application instead of a state form.
ATLANTA (AP) - The Georgia House of Representatives has approved two labor law changes that Republican leaders say would protect workers and boost market competition.
ATLANTA (AP) - The Georgia House of Representatives has approved proposed changes to a 2011 law targeting illegal immigration.
NEW YORK (AP) - Prosecutors finished presenting evidence to a jury hearing the cannibalism conspiracy case against a New York police officer Monday after showing jurors a video of a screaming woman, made to appear as if cooking over an open flame, and other disturbing images from websites devoted to torturing and eating women.
TAMPA, Fla. (AP) - Appearing in public for the first time since she was acquitted of murder, Casey Anthony revealed that she doesn't have a job or a car, lives with friends and relies on unsolicited gift cards and cash to get by.
NEW YORK (AP) - Investors brushed off early jitters about a potential slowdown in China and pushed the Dow to its highest close of the year.
ATLANTA (AP) - Republican lawmakers are moving to loosen restrictions on where Georgians can carry or keep firearms.


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BARBARA WOOD BEST FRIENDS SIGNED SERIGRAPH NUMBEREDBARBARA WOOD BEST FRIENDS SIGNED SERIGRAPH NUMBERED BARBARA WOOD BEST FRIENDS SIGNED SERIGRAPH NUMBEREDArtist: Wood, Barbara A. Title: Best Friends Image size : 32 1/2'' x 46 1/2'' Edition size: 350 + proofs Serigraph in color on wove paper. Signed in pencil, lower right and numbered. Retail Price: $1995 My Policies: SATISFACTION We guarantee your satisfaction with our Iron Clad 30 day Money-Back Guarantee. Just return your item in good condition with all documentation and we will refund you with no hassles. Our goal is to keep you as a long-term customer. If a return is made after 30 days then store credit is given in place of a refund. We will only ship to the address stated on your paypal account and not responsible if it hasnt been updated. PRIVACY We DO NOT share or rent your information with anyone. Your information is safe with us. SECURITY Smc-art has taken extreme precautions regarding site security. We have partnered with the industry leader Hacker Safe who certifies our site daily with the FBI/SANS Internet Security Test. Our site meets the highest security standards of the United States government, Visa, MasterCard, American Express, Discover & JCB. We also transmit the order with SSL software via COMODO 128bit encryption so you can rest easy! NO WORRIES If you make an error on your order, enter the wrong quantity, or you get billed incorrectly don't worry about it! We will fix it and make it right. So buy with confidence and see for yourself the difference when shopping. Numbers on the prints may vary from the picture this is just to show you its hand signed by the artist if it applies to it. ANY QUESTIONS CALL US AND ASK FOR JIMMY PLEASE CLICK TO SEE MY OTHER EBAY AUCTIONS Please feel free to email us any item you see and we will responded to you within 24 hours. Multiple purchases qualify for a shipping discount. Payment: We accept American Express, Discover, MasterCard, Visa and call for other payments. If your looking for any type of art please give us a call at and ask for JIMMY. You may also Please pay your items within 7 days or your item will be relisted! PLEASE EMAIL US IF YOUR OUTSIDE THE U.S.A TO GET SHIPPING FREIGHT CALIFORNIA RESIDENTS PAY 8.25% SALES TAX. Items in the Worthopedia are obtained exclusively from licensors and partners solely for our members' research needs. View Similar Items |
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Syria at war
Shaam News Network via AP video
March 18, 2013 11:23 AM
Associated Press
Syrian rebels said on June 21 they have received new weapons from friendly countries that could lead to changes on the ground and victories against President Bashar Assad's forces. The civil war has killed tens of thousands of people, displaced more than four million and turned neighbor against neighbor, with civilians paying the price. (Reuters)
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automatic switch company
June 5 antique truck show slated
The 21st annual Antique Truck Show will be June 5, 2011, at the Automatic Switch Company in Florham Park, N.J., the local chapter of the American Truck Historical Society announced.
Overdrive's Most Beautiful contest is back for a second year. Submit yourself or a female truck driver you know! The first-place winner will win a trip to The Great American Trucking Show in August and will be featured in a story in Overdrive. Submissions accepted through March 20.
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Construction costs in Bahrain to rise
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Construction costs in Bahrain are set to rise by 20 or 30 per cent after the implementation of the McKinsey labour reforms, a research said Tuesday. The study was presented at the workshop on the construction sector in the Kingdom organised by the Economic Development Board (EDB) in co-operation with the Bahrain Chamber of Commerce and Industry (BCCI).
According to Bahrain Tribune, the workshop was attended by more than 50 participants from the BCCI and private sector companies related to the construction and building sectors.
Top Headlines
- Turkish products exhibition opens in Bahrain
- Construction of Bahrain Chamber of Commerce and Industry's new headquarters awarded
- Economic Development Board meets with Bahrain Chamber of Commerce and Industry Labor Committee
- Bahrain industrial expo kicks off
- The BMA Organises an Islamic Finance Workshop in Tokyo


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Please login or register to enjoy the benefits of CGSociety! | ||||
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Award Winning Arcade Style Golf game now coming to Apple's iOS Devices
AWARD WINNING ARCADE STYLE GOLF GAME NOW COMING TO APPLE'S iOS Devices
We are super excited about a new really cool, award winning arcade-style game we have coming to the Apple iOS Platform on Thursday March 1st, called Sling Golf! The game has been available for the Blackberry Playbook for some time and here are a couple of the many great reviews we have received: - Simple to play, difficult to master, love it! - Super addicting, so simple in concept, so hard in practice. Great time sink. Very much recommended. Awesome! - Best $3 I have spent in a long time! So addicting, so fun, best game on BB App World. Hoping for some new maps. Thanks to the developers! The game will be free to download, with the ability to buy additional characters / courses as in app purchases for only .99 cents. An initial teaser video on YouTube located at the link here: http://youtu.be/0MTWX9M-Sxg Complete Features: Universal Application 6 very unique and challenging Golf courses 54 holes in total, 9 per course 5 cool golf characters to choose from 20 Un-lockable achievements and awards with Game Center integration Cool animations and sound New and challenging courses will be added periodically. http://boltcloud.com/discover-slinggolf www.facebook.com/slinggolf Twitter: @SlingGolf About the Developers www.boltcloud.com Innovative, Visionary firstname.lastname@example.com |
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This deal is based on two sharing and includes overnight accommodation, breakfast, 3-course dinner, bottle of wine and late checkout until 1pm. Saturdays are an extra £20 (payable directly to the hotel). Prices, dates and saving were correct at time of publication. Valid for stays from 15 July-30 September. Parking is £10 per day.
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Lovely room, great location, friendly staff, good food. |
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The food was excellent |
Could do with a make over |
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lovely room and breakfast |
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It is in a good position for shopping and not too far from the station and is on the bus route for the bay. |
I didn`t think it was good enough overall for a 4 star hotel . I paid for an upgraded room with a castle view but we could hardly see any of the castle . The food in the restaurant was disappointing and there seemed to be a lack of staff especially at the bar. |
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"We've introduced the Clemson preparation already," Holgorsen said. "Started sprinkling some stuff in. There's a fine line there, though. We didn't want to overkill it because of the time off. We'd just have to refresh their memories once here.
"Now, though, we begin refreshing. It's all in, we just have to practice it."
In regard to the team's health, Holgorsen seemed pleased, aside from the loss of defensive back Terence Garvin, the Mountaineers' third-leading tackler (72), who is out following knee surgery.
"Other than him, we're as healthy as we've been all year," said the WVU coach. "We had a couple weeks off that helped with treatment. Then we had five or six practices last week where everybody was flying around pretty good. It was the first time in quite some time."
WVU will be practicing at Barry University. Holgorsen said the school has no football team and, thus, no football field, but it has two soccer fields. "I haven't been there yet," said the coach, "but they say the practice conditions are really good."
So the Mountaineers are in sunny Florida. Orange Bowl preparations for Clemson have begun. And the team is in its fancy digs at the Fontainebleau.
"It's nice," Holgorsen said of the hotel. "So nice the kids can't afford any of the things that can get them in trouble."
Reach Mitch Vingle at 304-348-4827, mitchvin...@wvgazette.com or follow him at twitter.com/MitchVingle.


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Rosario E. ("Chachy") Heppe serves on the Executive Management Team at Fluor Corporation, a Fortune 150, 101-year company that delivers engineering, procurement, construction and maintenance (EPCM) to governments and companies around the world. Prior to joining Fluor, she was an Assistant General Counsel at American International Group, Inc. in New York, where she oversaw the global anti-bribery (FCPA) and economic sanctions (OFAC) programs for over 100,000 employees in over 130 countries; the Corporate Counsel and Assistant Secretary of Dresser, Inc. in Dallas; and an Associate in the International Practice Group of the global law firm Baker & McKenzie.
Chachy is a Dallas-ISD graduate (W.T. White High School), and earned her B.A. (Liberal Arts Honors Program) from the University of Texas at Austin and her J.D. from Southern Methodist University in Dallas. She is licensed to practice law in Texas and New York. Chachy is active with select non-profit organizations, and most enjoys the outdoors and arts with her husband and three young children, who are learning to speak German and Spanish–their parents' mother tongues.
Chachy was born in Dallas. Her parents and grandparents are from Mexico and Little Mexico in Dallas. She believes that her education has greatly afforded her the opportunities she has been privileged to achieve, and, therefore, believes it is critical that more Latinos and other historically under-represented people of the Dallas/Fort Worth metroplex (DFW) pursue higher education to maximize their potential and become future DFW and global leaders.
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