Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Titan Pharmaceuticals
Age
40–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Idiopathic Parkinson's disease (PD). As defined by:
* presence of bradykinesia and either rest tremor or rigidity
* history of asymmetry of PD signs
* history of progression of PD signs, and
* no other suspected cause of PD signs
Patient is between 40 and 70 years of age, inclusive
Patient is L-dopa-sensitive and has unequivocal clinical "off" periods as documented by home diary, completed on 4 consecutive days with an average of 1.5 hours/day in the clinically "off" state
Patient is Hoehn \& Yahr stage III or higher in the practically defined "off" phase
All other medical problems are stable or under control and are not contraindications to general anesthesia or stereotactic neurosurgery
Patient's brain magnetic imaging resonance (MRI) shows no abnormality that would contraindicate Spheramine implantation
Patient does not have a major psychiatric problem or dementia
Patient must give written informed consent to participate in this study
Patient must be on a stable dose of antiparkinsonian medication for at least 1 month prior to completion of the home diary assessment and the baseline UPDRS assessments
If the patient is a woman of childbearing potential, she must not be nursing or pregnant and must use an adequate form of birth control for the duration of the study deemed appropriate by the investigator such as oral contraceptives, IUD, or condoms
Patient must be living with or in close constant contact with a person who can contribute information as to the patient's condition before and after implant and provide assistance, if necessary
Patients exhibiting only a tremor-based symptomatology
Patients exhibiting very severe dyskinesias (lasting more than 2 hour/day) exacerbated by L-dopa, evaluated as 4/4 on the dyskinesia scale (violent dyskinesias, incompatible with any normal motor task)
Women of childbearing potential without contraception
Patients who are non-cooperative or incapable of completing self-evaluation scales or diaries
Patients presenting with known pharmacologic immunosuppression related to chemotherapeutic treatment for malignancy, autoimmune disease, allografts or other medical conditions associated with immunosuppression
Patient's cardiovascular, pulmonary, renal and hematological state contraindicates use of general anesthesia
Evidence of abnormal coagulation including PT \> 13 sec, PT \> 35 sec or platelets \< 5 ml
Patients having had previous stereotactic brain surgery
Patients treated by apomorphine pump
Patients with significant cognitive impairment, untreated or treatment resistant depression, psychosis, hallucinations or delusions that would prevent their effective participation in the study
Patients who have participated in another experimental drug or device trial in the past 30 days
