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Official Study Title: An Open Label Extension Study of the Safety and Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Utility of IPX066 in Subjects With Parkinson's Disease
Sponsor: Impax Laboratories, Inc.
Clinicaltrials.gov ID: NCT01096186
Study ID: IPX066-B09-03

Summary

IPX066 is intended for chronic treatment of motor symptoms  Motor SymptomsThe physical symptoms of PD, such as balance, rigidity, tremor, freeze attacks, involuntary movements (dyskinesia), slowness of movement (bradykinesia), walking/gait, postural difficulties*, writing difficulty, swallowing difficulty* (dysphagia), muscle pain*, masked face*, speech problems* and general loss of motor skills. for all stages of Parkinson’s disease (PD). This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:

• IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. of IPX066 in Subjects with 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.
• IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard 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. - Levodopa)  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain.
• IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)

All participants will be given IPX066 for nine months.

IPX066 is 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. for the treatment of motor symptoms of Parkinson’s disease.  IPX066 is a new formulation of carbidopa and levodopa.  IPX066 is designed to rapidly achieve therapeutic effect (i.e. motor turn “on”) and to maintain that effect for several hours.  The consistent delivery of levodopa from IPX066 may improve control of motor symptoms and reduce side effects  Side Effects Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include such symptoms as headache, nausea and upset stomach. In some cases, side-effects may cause more severe medical problems. of the drug.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Balance, General PD symptoms, Loss of Motor Skills, Postural difficulties, 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. , 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. , 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.

Time Commitment

• More than six months
• Four site visits and possible additional visits to obtain supplementary IPX066 at approximately one- to two-month intervals as needed

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either

Inclusion Criteria

• Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.

Exclusion Criteria

• Received an investigational medication other than those from an IPX066 trial within four weeks prior to the planned start of treatment.
• Anticipates functional neurosurgical treatment for PD (e.g., ablation or 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. during study participation.
• Received within four weeks prior to baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. visit or planning to take during study participation nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).

Enrollment

Expected Enrollment: 500 (US)
Date Enrollment Began: Mar 2010
Date Enrollment Ends: Aug 2011
Last Updated Date: Jul 06 2010
Trial Post Date: Jun 23 2010
Website: http://clinicaltrials.gov/ct2/show/NCT01096186

Primary Contacts and Locations

California

• Jeff Mulchahey, Ph.D.
  jmulchahey@impaxlabs.com
  Phone: (510) 476-2036
  31047 Genstar Road
  Hayward, CA 94544
  USA
  

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