• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: A multicenter, randomized, double-blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. placebo-controlled, 5-arm, parallel-group trial to assess rotigotine transdermal system dose response in subjects with advanced-stage parkinson's disease
Sponsor: SCHWARZ BioSciences, Inc.
Clinicaltrials.gov ID: NCT00522379
Study ID: SP921

Summary

The purpose of this study is to evaluate the effectiveness  EffectivenessAbility of a drug or treatment to produce a result. and safety of four specified doses of rotigotine compared to placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. in people with advanced-stage Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD).

After a screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. period of up to 42 days participants will be randomly assigned either to rotigotine patch or placebo patch. Participants will be titrated to their optimal dose, over a four week period. After participants have reached their optimal dose they will be maintained on this dose for a three month period. At the end of the three month period the doses will continuously decrease over a four day period.

Efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. will be assessed by participants completing diaries to capture "off" time on specified days. Safety will include adverse events, vital signs, body weight, electrocardiograms, clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. laboratory values and physical and neurological examinations.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Movement Symptoms

Writing difficulty, Walking/Gait,  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. Uncontrollable movements (Dyskinesia)  DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa. , Tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Postural difficulties, Loss of Motor Skills, General PD symptoms, Freeze Attacks,  Freeze AttacksThe sudden loss of ability to move. Balance

Time Commitment

• Less than six months
• One screening visit; 4 weeks once a week; 12 weeks of bi-weekly then bi-monthly visits; 1 follow-up visit; possibly 1 post-follow-up visit every 3 months up to one year thereafter.

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either
• Minimum Years Since Diagnosis: 3

Inclusion Criteria

• PD diagnosis for longer than 3 years
• On a stable dose levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. but symptoms not adequately controlled
• Able and willing to complete diary on specific days

Exclusion Criteria

• Previous use of rotigotine or Neupro
• Atypical Parkinson's syndrome
• Having undergone procedures such as: pallidotomy, thalamotomy, and deep brain stimulation  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. or a fetal tissue transplant
• Presence of dementia,  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. psychosis,  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's. or hallucinations
• Epilepsy
• Clinically relevant heart, kidney or liver problems
• Symptomatic orthostatic hypotension (sudden dropping of blood pressure when standing)
• Skin sensitivity to adhesives or unresolved skin conditions
• History of chronic alcohol or drug abuse
• Impulse control disorder

Enrollment

Expected Enrollment: 500 (US)
Date Enrollment Began: Jul 01 2007
Last Updated Date: Jan 29 2008
Trial Post Date: Jan 29 2008
Website: http://www.parkinsonspatchstudy.com/

Primary Contacts and Locations

North Carolina

• Steven Neilson — Principal Clinical Project Manager
  Schwarz Biosciences, Inc.
  Phone: (919) 767-2528
  Raleigh, NC 27607
  USA
  

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