Please assess the completion status of the following clinical trial:

Trial Title: Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin for the Treatment of Bilateral Idiopathic Parkinson's Disease

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Willing and able to give written Informed Consent~2. Diagnosed with bilateral idiopathic PD~3. Diagnosis of PD \> five years, using diagnostic criteria from core assessment program for surgical interventional therapies CAPSIT (1999)~4. Males/females between 48 and 65 years~5. Women must be postmenopausal, with last menstrual period being over two years ago~6. Male patients must agree to use at least two methods of contraception for at least 3 months following ProSavin administration if they and their partner is of child-bearing capacity~7. Response to L-DOPA where an increase in dose is unacceptable to the patient due to potentiating the fluctuations in motor functions~8. Hoehn and Yahr stage 3 and 4~9. UPDRS (Part III) of between 20 and 60 in the OFF state~10. Stable dosing of PD medication, including L-DOPA, for six weeks prior to surgery~11. Positive response to dopaminergic therapy as defined by a 50% improvement in UPDRS (Part III) between the OFF and ON states~12. Presence of motor fluctuations~13. Willing to have current treatment withdrawn for up to 24 hours prior to surgery therefore being in an OFF state for surgery~14. Willing to have their L-DOPA dosage reduced/withdrawn at the discretion of the principal investigator (PI) at regular intervals following surgery to allow assessment of ProSavin in the absence of concomitant anti-{Parkinsonian medication~15. Affiliated with the French social security health care system (Patients enrolled in France only)~Exclusion Criteria:~1. Major surgery within the 28 days prior to enrolment~2. Severe disabling dyskinesias \> or = 51% of the day as defined by the UPDRS (Part IV)~3. History of psychosis or current treatment with dopamine blocking agents of any kind~4. Severe depression as defined by a BDI score of \>16. Any treatment for depression should be limited to seretonergic therapies and those that do not target the dopaminergic pathways~5. Prior treatment with tolcapone within the six months prior to enrollment into the study, due to its ability to modify dopaminergic pathways in the brain~6. History of epilepsy or any other co-morbid condition that the Investigator believes presents an unacceptable health risk to the patient in conjunction with the procedures in this protocol~7. Life-threatening illness unrelated to PD~8. History of stereotactic or other surgery for the treatment of PD~9. Premenopausal women~10. Alcohol or other substance abuse~11. Clinically significant laboratory test abnormalities, including full blood count, chemistry panel, liver function tests, electrocardiogram (ECG), Chest X rays~12. Any contraindication for undergoing an MRI scan of the head~13. Intercurrent illness or infection 28 days prior to enrolment~14. Abnormal MRI findings such as mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumours, vascular diseases, trauma or arteriovenous malformations (AVM)~15. Prior regular exposure to neuroleptic agents~16. History of treatment with any agent that may induce PD or PD symptoms within the last three months prior to enrollment~17. Contraindications to use of anaesthesia~18. Treated with dopaminergic antagonists six months prior to screening~19. Concurrent antiretroviral therapy that would inactivate the investigational agent~20. History of any investigational agent within 28 days prior to ProSavin administration~21. Participation in a prior gene transfer therapy study~22. Enrolment in any other clinical study, for any condition, including those relating to PD, throughout the duration of the ProSavin study~23. Current of anticipated treatment with anticoagulant therapy or the use of anticoagulation therapy within the four weeks prior to surgery~24. Diagnosis of multiple systems atrophy (MSA) following assessment of the autonomic nervous systems function (e.g. blood pressure, difficulty in urinating and sexual activity) and MRI during the screening process~25. Administration of subcutaneous rescue remedy apomorphine~26. Patient unable to adhere to their prescribed Parkinson's disease treatment regime.

- Gender: ALL
- Minimum Age: 48 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- Dose Evaluation (Type: EXPERIMENTAL): To assess the safety and efficacy of up to three dose levels of ProSavin
- Sham element (Type: SHAM_COMPARATOR): The potential use of sham comparator to confirm efficacy

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete