Movement Disorders

Clinical Trials

  1. Stalevo Study - wearing off
  2. Early Onset Parkinson's Disease Study
  3. Phase I trial of a new medication for Parkinson's Disease

  4. Closed Trials

Stalevo Study - wearing off

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:

Exclusion Criteria:

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: 

Exclusion Criteria:

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: 

Exclusion Criteria:

Closed Trials

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 č-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).

Myobloc Study

Enrollment: Closed

Title: An open-label safety and immunogenicity study of MyoblocTM (Neurobloc´âó, 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.

Stanford Medicine Resources:

Footer Links: