• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: A Phase 2, 12-Week, 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. Dose-Finding , Placebo-Controlled Study to Assess the Efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe PD Experiencing Motor Fluctuations and Dyskinesias
Sponsor: Schering-Plough Research Institute
Clinicaltrials.gov ID: NCT00406029
Study ID: P04501

Summary

The purpose of the study is to assess the efficacy and safety of a range of doses of an investigational drug  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. (SCH 420814) when used together with a stable dose of levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. decarboxylase inhibitor to treat 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). SCH 420814 is a drug that may prove to be effective in treating PD, and therefore the investigators are currently gathering data to allow them to gain approval from the FDA so that SCH 420814 can be used to treat people with PD in the future.

This study will be comparing four doses (1 mg, 2mg, 5 mg, and 10 mg taken twice a day) of SCH 420814 with 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. (sugar pill). Whether the volunteer receives SCH 420814 or placebo will be decided by a process called randomization  RandomizationA method based on chance by which study participants are assigned to a treatment group (arm). Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. (as in the flip of a coin). A participant’s chance of receiving the investigational drug, SCH 420814, is 80 percent. The study is double-blind, which means neither the participant nor the study doctor will know whether he or she is receiving the study medication or placebo.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Movement Symptoms

Loss of Motor Skills, 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. Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , 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. 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.

Time Commitment

• Less than six months
• 1-2 week screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. period, 1 week diary, 12-week double-blind treatment (visits at day 1, weeks 2, 4, 6, 8, 10, 12), 6-week safety follow-up (visits at weeks 2, 4, 6)

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either
• Minimum Years Since Diagnosis: 5

Inclusion Criteria

• Participants must be 30 years of age or older, of either sex and of any race, with a diagnosis of moderate to severe idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. (classic) PD for at least 5 years and on levodopa for at least 2 years.
• During the diary period, participants must demonstrate a minimum of 2 hours of “off” time during awake time per day on 3 consecutive days.
• Women of childbearing potential must have a negative pregnancy test at Visit 2. If participant is postmenopausal (not surgically induced), she must be postmenopausal for at least 2 years before study entry. If not, proper birth control must be used.

Exclusion Criteria

• People with any form of drug-induced or atypical parkinsonism, cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment, a history of major depression, unstable mild depression or 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 anyone taking Tolcapone (an adjunct to levodopa/carbidopa)  CarbidopaDrug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects. will be excluded.
• People who’ve had previous surgery for PD.
• People who daily consume more than two glasses of wine.
• People who have received any treatment including potentially hepatotoxic drugs (drugs which are destructive to the liver) more recently than the approved period prior to the trial start or those who must continue to receive treatment.
• Because it is not known whether SCH 420814 passes into breast milk and because the effects, if any, of SCH 420814 on the developing human are unknown, women who are breastfeeding or who are considering breastfeeding are excluded from this trial.
• People who have used any other investigational drugs within 30 days of Screening.

Enrollment

Expected Enrollment: 200 (US)
Date Enrollment Began: Nov 01 2006
Last Updated Date: May 16 2008
Trial Post Date: May 16 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00406029?term=parkinsons+schering&rank=1

Primary Contacts and Locations

New Jersey

• Pauline Lindor
  pauline.lindore@spcorp.com
  Phone: (908) 740-2845
  2000 Galloping Hill Road
  Kenilworth, NJ 07033
  USA
  

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