Clinical Trials
Title: A prospective, multi-center, randomized open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to Stalevo® on motor function and quality of life in patients with Parkinson's disease with end-of-dose wearing off CELC200AUS11
Investigator: This study is being conducted by Novartis Pharmaceuticals Corporation
Site Principal Investigator: Dr. Helen Bronte-Stewart
Disease/Condition under Investigation: Parkinson's disease
Purpose: To test the effects Stalevo®, a medicine currently on the market that is used to treat people with Parkinson's disease. Stalevo is a combination of Sinemet and Comtan and helps to extend the period of action of Sinemet alone. This drug may have an impact in motor symptoms and quality of life in patients who are experiencing end-of-dose wearing off.
Phase(s): IV
Treatments: Stalevo® 50, Stalevo® 100, Stalevo® 150
Enrollment: open
Inclusion Criteria:
- male or female between 30-80 years of age
- have been clinically diagnosed with idiopathic Parkinson's disease
- have end-of-dose wearing off as determined by the investigator
- currently taking a stable dose of immediate release carbidopa/levodopa 25/100 mg for at least one month prior to study
Exclusion Criteria:
- previous or current use of Comtan or Tasmar
- a diagnosis of secondary or atypical parkinsonism
- unstable Parkinson's disease requiring booster doses or treatment with "when needed" dose regimens of levodopa
- the following standard carbidopa/levodopa doses and strengths are not permitted:
- patients taking immediate release carbidopa/levodopa 10/100 or 25/250
- patients taking fewer than 3 or more than 6 daily intakes of immediate release carbidopa/levodopa 25/100
Early Onset Parkinson's Disease Study
Title: A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo® 100 (t.i.d.) vs. immediate release carbidopa/levodopa 25/100 mg (t.i.d.) in Parkinson's disease patients requiring levodopa CELC200A2305
Investigator: This study is being conducted by Novartis Pharmaceuticals Corporation
Site Principal Investigator: Dr. Helen Bronte-Stewart
Disease/Condition under Investigation: Parkinson's disease
Purpose: To demonstrate Stalevo® provides significantly greater symptomatic benefit than standard formulation carbidopa/levodopa administered at the same levodopa dosage when used as initial levodopa therapy in patients with early PD.
Phase(s): III
Treatments: Stalevo® 100, Sinemet® 25/100
Enrollment: open
Inclusion Criteria:
- male or female between 30-80 years of age
- have been clinically diagnosed with idiopathic Parkinson's disease
- Parkinson's disease warranting treatment with levodopa therapy according to the investigator's assessment
Exclusion Criteria:
- a diagnosis of secondary or atypical parkinsonism
- diagnosis of Parkinson's disease for more than 5 years prior to Screening
- previous use of levodopa in any formulation, entacapone, or tolcapone for more than 30 days or any time within 60 days prior to baseline
- use of a dopamine agonist within 60 days prior to baseline
- history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrences or metastases, with the exception of localized basal cell carcinoma of the skin
- clinically significant ECG abnormality
Phase I trial of a new medication for Parkinson's Disease
Title: A randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate improvement in motor symptoms as assessed by the Unified Parkinson's Disease Rating Scale Motor Examination (UPDRS-ME) in male and female patients with moderate Parkinson's disease after single dose administration of L-001067743, Sinemet® 25/250 mg, or placebo
Investigator: This study is being conducted by Merck & Co., Inc.
Site Principal Investigator: Dr. Helen Bronte-Stewart at Stanford University, in conjunction with Dr. James Tetrud at the Parkinson's Institute, Sunnyvale, CA.
Disease/Condition under Investigation: Parkinson's disease
Purpose: To evaluate the single-dose efficacy and safety/tolerability of L-001067743 7mg in male and female patients with moderate Parkinson's disease as assessed by the UPDRS-ME.
Phase(s): I
Treatments: L-001067743 7mg, Sinemet® 25/250 mg, placebo
Enrollment: open
Inclusion Criteria:
- male or female between 50-70 years of age
- have been clinically diagnosed with idiopathic Parkinson's disease
- have been on a stable dose of levodopa for at least 4 weeks prior to study
- does not smoke or use any other nicotine-containing products
Exclusion Criteria:
- a diagnosis of secondary or atypical parkinsonism
- patient has known intolerance to or hypersensitivity to levodopa or carbidopa or to any ingredients in Sinemet®
- patient has dyskinesia or episodes of 'freezing'
- patient had surgery, donated blood or participated in another clinical study using investigational drugs within 4 weeks prior to screening
Precept Study
Enrollment: Closed
Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 (Precept) in Patients With Early Parkinson's Disease (PRECEPT) C1347c/204/PD/US-CAIND #60,982
Investigators: This study is being conducted by the Parkinson Study Group (PSG) under the sponsorship of Cephalon, Inc (Cephalon).
Site Principal Investigator: Dr. Helen Bronte-Stewart
Disease/Condition under Investigation: Parkinson's disease
Purpose: To look at how safe and effective CEP-1347 (Precept) is in patients with early Parkinson's disease. It measures the effect of Precept on Parkinson's disease by giving the patient Precept and then measuring the amount of time that passes before the patient needs standard Parkinson's disease medications to treat their symptoms. It also looks at the effect that Precept has on certain brain cells by using an investigational radioactive material called Ÿ-CIT (beta-CIT).
Phase(s): II, III
Treatments: 20 milligrams total each day of CEP-1347 (low dosage), 50 milligrams (medium dosage), 100 milligrams (high dosage), or placebo (a pill that looks like CEP-1347 but has no active ingredients).
Enrollment: Closed
Title: An open-label safety and immunogenicity study of MyoblocTM (Neurobloc, Botulinum Toxin Type B) Injectable Solution in patients with cervical dystonia AN072-401CD/NORTH AMERICA
Investigator: This study is being conducted by Solstice Neurosciences, Inc.
Site Principal Investigator: Dr. Helen Bronte-Stewart
Disease/Condition under Investigation: dystonia
Purpose: To evaluate the safety and effect of repeat doses of Myobloc over time.
Phase(s): IV
Treatments: between 2500-25000U of Myobloc (Botulinum Toxin Type B) injections every 3 months.