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This is the category page. Below are all of the research programs that are associated with it
- Alzheimer's Disease -
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY TRIAL OF BAPINEUZUMAB (AAB 001, ELN115727) IN PATIETNS WITH MILD TO MODERATE ALZHEIMER’S DISEASE WHO ARE APOLIPOPROTEIN Eε4 NON-CARRIERS (Protocol #ELN115727-301)
(1_20080312_118)
This is a randomized, double-blind, placebo controlled study using a non-FDA approved drug, Bapineuzumab, for use in participants with Alzheimer’s disease. Participants will complete approximately 20 study visits over the course of approximately 18 months. All participants will receive a specific laboratory test that uses blood to determine if the patient is an apolipoprotein Ee4 carrier. Participants are randomized to receive either the study drug or placebo. The study drug will be administered through infusions. Infusions are scheduled on 6 separate occasions, once every 13 weeks, over a period of 65 weeks. Participants will then be followed for an additional 13 weeks after their last infusion of study medication. The drug infusion takes about one hour and will be administered in the multi-purpose area of the Cancer Center at Lehigh Valley Hospital. Blood will be taken right before each treatment and at visits 3 and 7. There will be an observation period of 4 hours following the first two infusions. Both the caregiver and the participants will be asked questions and will be required to complete questionnaires and assessments to monitor improvement that will take approximately up to 90 minutes to complete. ECG’s are performed 5 times during the study at different times, and MRI’s will be performed 7 times during the course of the study. The duration of each patient’s participation is approximately 83 weeks.
- Cervical Dystonia:
CD PROBE - CERVICAL DYSTONIA – PATIENT REGISTRY FOR OBSERVATION OF BOTOX EFFICACY (Protocol Number MedAff BTX-0718)
(2_20090513_118)
This is an observational study to capture real world clinical practices of doctors who treat patients with Cervical Dystonia. Patients diagnosed with cervical dystonia and treated with Botox will be asked to participate. Participants will be asked a series of questions about their medical history and previous treatments. Collection of follow-up information will be done via 2 phone calls and will continue for 6 months after the patient has been injected with Botox and return to the office one additional time at the 6 months point. Questionnaires will take approximately 30 minutes to complete. Patients will received a $25.00 gift card for the phone interviews and a $40.00 gift card for completing the end of study office visit.
- Intracranial Atherosclerotic Disease -
HDE Wingspan™ Stent System and Gateway™ PTA Balloon Catheter (Humanitarian Device)
(2_20070411_118)
This is not a clinical trial. Patients who present to the Neurointerventional service with intracranial atherosclerotic disease (ICAD), refractory to medical therapy, with intracrainial vessels >50% stenosis that are accessible to the Wingspan system may be offered this treatment. The effectiveness of this device for this use has not been demonstrated. This device is being used as a Humanitarian Use Device. The catheter is placed in the narrowed artery in the brain. The balloon if inflated to widen the artery. The Wingspan Stent, a small metal mesh tube is then placed in the ballooned artery. The Wingspan will self-expand to the size and contour of the inner wall of the ballooned artery. Once in place, the Wingspan Stent remains as a permanent implant.
- Multiple Sclerosis -
AN EXTENSION PROTOCOL FOR MULTIPLE SCLEROSIS PATIENTS WHO PARTICIPATED IN GENZYME SPONSORED STUDIES OF ALEMTUZUMAB CAMMS03409
(1_20090806_118)
This is an open label study three year extension study for patients who participated in the following three studies: CAMMS223; CAMMS323 (CARE-MS1); or CAMMS32400507 (CARE-MSII) and continue to meet the inclusion criteria. Patients will take alemtuzumab for three days. Safety and efficacy assessments will be performed periodically including questionnaires. Participation will last for three years (36 months) from the date of consent and enrollment. Patients will be required to have telephone follow-up and blood work once each month.
- Multiple Sclerosis -
DULOXETINE IN PATIENTS WITH CENTRAL NEUROPATHIC PAIN DUE TO MULTIPLE SCLEROSIS (PROTOCOL F1J-US-HMFR)
(2_20081003_118)
This study is for participants with central neuropathic pain due to Multiple Sclerosis (MS). Participants will complete a 12 week double blind study and will receive either 60mg of the study drug, Duloxetine; or placebo, which will be taken once a day for 6 weeks. After the 12 weeks all participants that completed the first 12 weeks successfully, will be eligible to enter an open label phase where they are guaranteed to receive Duloxetine, but at different doses. While on the study, participants will need to complete different assessment scales, physical exams, have blood work drawn and an EKG. All participants will be given an electronic diary to record their daily pain levels.
- Multiple Sclerosis -
A PHASE 3 RANDOMIZED, RATER-AND -BLINDED STUDY COMPARING TWO ANNUAL CYCLES OF INTRAVENOUS LOW – AND – HIGH DOSE ALEMTUZUMAB TO THREE-TIMES WEEKLY SUBCUTANEOUS INTERFERON BETA-1a (Rebif®) IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS WHO HAVE REPLAPSED ON THERAPY(PROTOCOL CAMMS32400507)
(1_20080611_118)
This is a randomized, rater-blinded study of the safety and efficacy of alemtuzumab in patients with relapsing-remitting multiple sclerosis (RRMS) who have experienced a relapse on therapy after having been on therapy for at least 6 months. Each participant will be on the study for two years. Participants will be randomized to one of three arms which include 2 annual cycles of low dose Alemtuzumab; 2 annual cycles of high dose Alemtuzumab; or 3 times weekly subcutaneous interferon beta-1a. Participants must be able to complete necessary questionnaires.
- Parkinson's Disease -
A OPEN-LABEL, MULTI-CENTER, FOLLOW-UP STUDY DESIGNED TO EVALUATE THE LONG-TERM EFFECTS OF RASAGILINE IN PARKINSON’S DISEASE SUBJECTS WHO PARTICPATED IN THE ADAGIO STUDY (Protocol TVP-1012/501 (ADAGIO Follow-up) version date 5/3/09 and consent dated 5/3/09)
(1_20090711_118)
This is a follow-up study to the ADAGIO trial that studied the effects of rasagiline on patients with early Parkinson’s disease. This study is an extension of that study and will include participants from the first study to evaluate the long term effects of the study drug. Participants will be followed every three months for up to two years and will include a 24 month treatment period where participants will be supplied with the study drug at no cost. Participants will need to periodically complete questionnaires.
- Parkinson's Disease -
A MULTI-CENTER, OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF E2007 AS AN ADJUNCTIVE THERAPY IN LEVODOPA TREATED PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS (PROTOCOL #E2007-G000-303)
(1_20070312_118)
Use of an investigational drug E2007 in patients with Parkinson ’s disease treated with Levodopa, with motor fluctuations. All participants will receive the active study drug and will involve outpatient visits only. Patients who have completed one of the core trials and who meet the inclusion criteria will be enrolled and enter the Titration Phase, lasting 4 weeks, followed by the Maintenance Phase, lasting 52 weeks.
- PENUMBRA IMAGING COLLABORATIVE STUDY (PICS): A MULTICENTER TRIAL TO ASSESS OUTCOME OF PATIENTS REVASCULARIZED BY THE PENUMBRA™ SYSTEM (Protocol #CLP 1953.A)
(2_20090306_118)
This is a registry study for patients being treated using the Penumbra system following an ischemic stroke. This study will collect information on participants routine procedures and evaluations; which include examinations and looking at functional outcomes. The information will be collected from the onset of the stroke symptoms through 90 days after the use of the Penumbra system.
- Stroke:
INTERVENTIONAL MANAGEMENT OF STROKE TRIAL CLINICAL PROTOCOL (“IMS III STUDY”): A PHASE III, RANDOMIZED, MULTICENTER, OPEN-LABEL, 900 SUBJECT CLINICAL TRIAL THAT WILL EXAMINE WHETHER A COMBINED INTRAVENOUS (IV) AND INTRA-ARTERIAL (IA) APPROACH TO RECANALIZATION IS SUPERIOR TO STANDARD IV rt-PA (Activase®) ALONE WHEN INITIATED WITHIN THREE HOURS OF ACUTE ISCHEMIC STROKE ONSET (NIH/NINDS PROTOCOL #U01-NS05220/NS054630)
(2_20060510_118)
Participants that meet the criteria will be randomized to receive either IA and will need to have an angio procedure; or participants will receive IV 0.3 mg over 20 minutes. Both groups will have a 24 hour exams; 5 day discharge exam; day 7 follow-up; 1 month telephone survey; 3 month blinded exam; in addition to the 6, 9 and 12 month telephone survey/follow-up.
- Study Closed to Accrual:
Multiple Sclerosis -
A PHASE 3 RANDOMIZED, RATER-BLINDED STUDY COMPARING TWO ANNUAL CYCLES OF INTRAVENOUS ALEMTUZUMAB TO THREE-TIMES WEEKLY SUBCUTANEOUS INTERFERON BETA-1a (Rebif®) IN TREATMENT-NAÏVE PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
(1_20080604_118)
This is a randomized, rater-blinded study of the safety and efficacy of alemtuzumab in treatment-naïve patients with relapsing-remitting multiple sclerosis (RRMS). Participants will be randomized to one of two treatment arms. Participants will be randomized to either 2 annual cycles of intravenous alemtuzumab or to 3 times weekly subcutaneous interferon beta-1a. Participants will be treated for at least two years and then safety follow-up for three years.
- Study Closed to Accrual:
Alzheimer's Disease - A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY TRIAL OF BAPINEUZUMAB (AAB 001, ELN115727) IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE (Protocol #ELN115727-302)
(1_20080313_118)
This is a randomized, double-blind, placebo controlled study using a non-FDA approved drug, Bapineuzumab, for use in participants with Alzheimer’s disease. Participants will complete approximately 20 study visits over the course of approximately 18 months. All participants will receive a specific laboratory test that uses blood to determine if the patient is an apolipoprotein Ee4 carrier. Participants are randomized to receive either the study drug or placebo. The study drug will be administered through infusions. Infusions are scheduled on 6 separate occasions, once every 13 weeks, over a period of 65 weeks. Participants will then be followed for an additional 13 weeks after their last infusion of study medication. The drug infusion takes about one hour and will be administered in the multi-purpose area of the Cancer Center at Lehigh Valley Hospital. Blood will be taken right before each treatment and at visits 3 and 7. There will be an observation period of 4 hours following the first two infusions. Both the caregiver and the participants will be asked questions and will be required to complete questionnaires and assessments to monitor improvement, which will take approximately up to 90 minutes to complete. ECG’s are performed 5 times during the study at different times, and MRI’s will be performed 7 times during the course of the study. The duration of each patient’s participant is approximately 83 weeks.
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