Low Dose Naltrexone: Hope for PPMS Sep 18, 2008
The new study was an Italian open-label trial on 40 patients to evaluate safety and tolerability of LDN in PPMS. It was published in the medical journal Multiple Sclerosis. Open-label means that everyone was receiving the medication; it was not compared with placebo. (Suite101.com)
Head-to-Head Study Results Demonstrated No Significant Difference Between NiQuitin(R) Patch and Champix (Varenicline Tartrate) in Long Term Quit Rates Jul 28, 2008
For example, a substantial proportion of quit attempts are made spontaneously, without much planning. Therapeutic nicotine is widely available without the need for a prescription or a visit to a doctor's office. (Canada Newswire)
New Hope For Rheumatoid Arthritis Sufferers: B Cells As Promising New Therapeutic Targets Jun 10, 2008
rner, M.D., an affiliate of the University of Berlin, the B cell investigation began with an open-label trial of one cycle of rituximab on 17 RA patients. The participants, 14 women and 3 men, had a median age of 51 years, a median disease duration of 14 years, and a history of failure to respond to DMARD and/or anti-TNF therapy. (Science Daily)
Infinity Announces Clinical Data Confirming Activity and Safety of IPI-504, a Novel Hsp90 Inhibitor, in Patients With Refractory GIST May 31, 2008
The open-label trial consisted of a dose-escalation phase and an expansion phase in which a total of 63 patients with either GIST (n=45) or other soft tissue sarcomas (n=18) were treated with IPI-504. In the dose-escalation phase, patients were treated on two schedules of administration at dose levels ranging from 90 to 500 mg/m(2). (Primezone Releases)
Novartiss FTY720 shows low relapse rate for multiple sclerosis Apr 18, 2008
Although there may be long-term risks, the FTY720 extension trial is an open-label trial, and he agreed that it is premature to conclude whether it is drug-related. Skin cancer is something we have seen, and we have implemented dermatology tests, said Aradhye. (FT.com -- Markets)
WEX Starts Phase III Trial of Tectin(TM) for Cancer Pain Apr 9, 2008
This open-label trial is designed to gather long-term efficacy and safety data. If successful, the results of these clinical trials would be the basis for regulatory filings in Canada seeking approval to market Tectin(TM) for cancer pain. (CCNMatthews Press Releases)
Medarexs Phase III melanoma drug Ipilimumab likely to be rejected by FDA due to missed primary endpoint, physicians say Feb 2, 2008
The open-label trial is one of three pivotal registrational trials to be submitted to the agency for approval as a potential therapy for melanoma, they said. Dr Antoni Ribas, a melanoma expert and associate professor at UCLA Medical Center said the FDA does not have a track record of approving a drug based on negative results. (FT.com -- Markets)
Sirolimus for Angiomyolipoma in Tuberous Sclerosis or Lymphangioleiomyomatosis Jan 10, 2008
Methods We conducted a 24-month, nonrandomized, open-label trial to determine whether sirolimus reduces the angiomyolipoma volume in patients with the tuberous sclerosis complex or sporadic lymphangioleiomyomatosis. Sirolimus was administered for the first 12 months only. (New England Journal of Medicine)
Similar Outcomes For Patients With ACS Treated With Different Anticoagulant Regimens Jan 3, 2008
The randomized, open-label trial was conducted at 450 academic and community-based institutions in 17 countries. A total of 13,819 patients with moderate- and high-risk ACS undergoing invasive treatment were enrolled between August 2003 and December 2005. (Science Daily)
Xeloda(R), Taxotere(R) and Herceptin(R) Combination Study Suggests Clinical Benefit in Invasive Breast Cancer with Shortened Treatment Cycle Dec 16, 2007
In the multi-center, open-label trial -- designed to investigate the activity of a short non-anthracycline-based preoperative treatment for early breast cancer in both HER2-negative and HER2-positive patients -- promising results were achieved after only four cycles of pre-surgical treatment as compared to the standard eight cycles. The majority of the 156 patients responded to the Xeloda-based therapy regardless of HER2 status, and both patient groups experienced a clinically significant... (PR Newswire)
Kosan Presents Updated Data on Hsp90 Inhibitor, Tanespimycin, in Multiple Myeloma at Ash Dec 9, 2007
The multi-site, open-label trial is being conducted primarily in the US and Europe. TIME-2 is designed to compare three different dose groups of tanespimycin (50, 175 and 340 mg/m2), each in combination with bortezomib (1. (PR Newswire)
Clinical Data Reported on Vidaza in Hematologic Malignancies and Advanced Solid Tumors Jun 3, 2007
"These studies will help provide us with insight not only into the continuing development of parenteral Vidaza, but, in particular, provide us direction for the development of oral azacitidine." Tolerability and hematologic improvement assessed using three alternative dosing schedules of azacitidine (Vidaza) in patients with Myelodysplastic Syndromes (MDS) - R. Lyons; Abstract #7083; June 2, 2007; 8am-12pm; McCormick Place Convention Center, S Hall A2) Interim results from a Phase II,... (PR Newswire)
Investigational nonstimulant Guanfacine XR significantly improved child, adolescent ADHD symptoms May 24, 2007
Similar to the 303 study, the objective of the 305 open-label trial was to assess the long-term safety and efficacy of GXR for the treatment of ADHD in children and adolescents aged 6 to 17 years. During the first month of this study, investigators made weekly adjustments as needed to each participants' once-daily GXR doses from 1 mg to 4 mg for optimal dosing, as defined by 30 percent or more improvement in ADHD-RS-IV total scores. (EurekAlert!)
NeuroStar(R) TMS Therapy Improved Quality of Life in Patients with Major Depression in Clinical Trials May 22, 2007
Separate Research Shows Significant Improvement of Symptoms in Open-label Trial SAN DIEGO, May 21 /PRNewswire/ -- New research on patients with moderate-to-severe depression, who had not received adequate benefit from previous antidepressant therapy, demonstrated that NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy significantly improved quality of life and functioning when compared to patients receiving sham (placebo) treatment ... Significant Improvement of Depression Symptoms in... (PR Newswire)
Boston Scientific Reports Positive Two-Year Data From TAXUS V ISR Trial Mar 26, 2007
The TAXUS V ISR trial is a prospective, randomized, open-label trial studying 396 patients at 37 centers across the United States. Previously reported nine-month results demonstrated that the TAXUS Stent resulted in clinically and angiographically statistically significant outcomes in the treatment of in-stent restenosis compared to brachytherapy. (PR Newswire)
Antidepressants Don't Help Kleptomaniacs Mar 17, 2007
But open-label trials, in which information about who is taking medication and who is taking a placebo is public, are notoriously unreliable. "In open-label trials, it only looks like they might work," Sussman said ... Response rates turned out to be the same in both groups, suggesting that the earlier effects in the open-label trial were due to a placebo effect. (Washington Post)
