Navigation Links
Ovation further advances development pipeline with new phase III epilepsy study

DEERFIELD, Ill., September 4, 2007 OVATION Pharmaceuticals, Inc. announced the initiation of a pivotal Phase III clinical trial evaluating clobazam, a unique 1,5 benzodiazapine with significant anticonvulsant properties, as adjunctive treatment for patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy that frequently persists into adulthood. In previous studies clobazam was shown to be well tolerated in patients with LGS and met the primary endpoint in a Phase II dose range finding study of a significant reduction in drop (or atonic) seizures compared to baseline. Drop seizures are the most debilitating of the LGS seizures types, which can result in severe trauma to the brain and body. This latest study demonstrates OVATIONs progress in advancing its central nervous system (CNS) development pipeline.

LGS, like many catastrophic epilepsies, can be both devastating and overwhelming for patients and their families, and clobazam may offer improved seizure control for patients affected by this condition, said Stephen D. Collins M.D., Ph.D., Chief Scientific Officer and Vice President of Clinical Affairs, Ovation Pharmaceuticals. OVATION remains committed to exploring new treatment options for epilepsy, particularly where current treatment needs are not fully addressed.

The Phase III study is designed to evaluate the safety and efficacy of clobazam in the reduction of atonic seizures at three dose levels in children and adults (ages 2-60 years) with LGS. The company plans to recruit patients with LGS at approximately 60-65 sites. The double-blind, placebo-controlled study will last up to 23 weeks. For more information and study locations, please visit

"LGS is one of the most severe forms of epilepsy and we desperately need new treatment options," said Eric R. Hargis, President and CEO of the Epilepsy Foundation. "We hope that the Phase III study shows great results and that clobazam brings new hope to the children and young adults who suffer from this devastating condition." For this patient population, there is an urgent need for novel therapies that help manage the disease, said lead study investigator Joan A. Conry, M.D., Professor of Neurology and Pediatrics in the Department of Neurology at Childrens National Medical Center in Washington, D.C. We know clobazam has an internationally well established safety and efficacy profile and if the results we have seen thus far are an indication of its potential in patients with LGS in the U.S., we may finally have a treatment that will fill an important unmet need.

Clobazam is one of the key products in OVATIONs CNS development program. The company is advancing its near-term pipeline on other fronts as well. In July 2007, the company initiated a clinical trial to evaluate a novel intravenous formulation of carbamazepine, a widely used oral antiepileptic drug, in adult patients with epilepsy. The launch of another oral anticonvulsant for rare and refractory epilepsies is anticipated next year.

Contact: Nikki Nelson
Edelman Public Relations

Related medicine news :

1. Genetic innovation
2. Biocon To Shift Focus On Innovation To Accelerate Growth
3. IIT Delhi To Display Its Technological Innovations In Open House
4. Patent for Seminal RNAi innovation Cleared in Australia
5. Innovation Needed In The Field Of Diagnostics: Nair
6. A young scientist recognized for biomechanics innovations
7. Blood Safety, Supply, and Innovations Addressed at Conference
8. New Innovation in Clubfoot Treatment
9. Further support for use of statins in Alzheimer’s disease
10. Clinical Impact of Activity and Abdominal Pressure on Pelvic Floor Dysfunction Need to Be Further Analyzed
11. Doctor Accused Of Misdiagnosing 208 Patients: Further Investigation Ordered
Post Your Comments:
(Date:12/1/2015)... ... December 01, 2015 , ... The Multiple System Atrophy ... and funds for Multiple System Atrophy (MSA) research, timed today to coincide with Giving ... things from patients including their ability to work and be productive, to do simple ...
(Date:12/1/2015)... ... 2015 , ... Henderson, a town of about 6,300 people, ... a partnership this year with Aeneas Internet and Telephone. , With faster Internet ... entrepreneurs who want to build a business. Whether startups or long established companies, ...
(Date:12/1/2015)... ... ... Integrated Rental Services (“Integrated Rental”), a growing medical equipment ... With support from JII, Integrated Rental is poised for expansion while improving its ... labs and medical facilities across the United States. , General Manager Robert Bean ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... and hematology continuing medical education (CME), today announced that the first annual School ... New York. , “The prevention, detection and treatment of gastrointestinal cancers are undergoing ...
(Date:12/1/2015)... ... , ... Dr. Paul Vitenas, one of the top cosmetic surgeons in ... as the Best Single Physician Practice in the nation. Dr. Vitenas and his practice ... by the industry publication. , Dr. Vitenas said he was very honored to ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... , Dec. 01, 2015 ... the "Veterinary Equipment and Disposables Market by ... report to their offering. --> ... "Veterinary Equipment and Disposables Market by product, ... report to their offering. --> Research ...
(Date:12/1/2015)... 2015 CytRx Corporation (NASDAQ: CYTR ), ... today announced that it has reached its enrollment target ... 3 clinical trial of aldoxorubicin in patients with previously ... be completed in Q1 2016. The Phase 3 trial is ... Protocol Assessment from the FDA at 79 sites in ...
(Date:12/1/2015)... , Dec. 1, 2015  InCarda Therapeutics, Inc. (InCarda), ... commercialization of therapies for cardiovascular conditions via the inhalation ... business in Australia . InCarda is ... Australia in the first half ... and medical centers in Adelaide ...
Breaking Medicine Technology: