Study on Tolerability of Repeat i.c.v. Administration of sNN0031 Infusion Solution in Patients With PD

NCT ID: NCT02408562

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-10-31

Brief Summary

This is a phase I, randomised, placebo-controlled study to assess the safety and tolerability of two 2-weeks cycles of i.c.v. administration of sNN0031 infusion solution to patients with PD of moderate severity with persisting on-off symptoms in spite of other PD medications.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sNN0031

sNN0031 Infusion Solution (in aCSF) for intracerebroventricular (i.c.v.) administration by an implanted infusion pump

Group Type: EXPERIMENTAL

i.c.v. infusion of sNN0031 by an Implanted infusion system

Intervention Type: OTHER

I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.

Placebo

Articifial Cerebro Spinal Fluid (aCSF) for intracerebroventricular (i.c.v.) administration by an implanted infusion pump

Group Type: PLACEBO_COMPARATOR

i.c.v. infusion of aCSF by an Implanted infusion system

Intervention Type: OTHER

I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.

Interventions

i.c.v. infusion of sNN0031 by an Implanted infusion system

I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.

Intervention Type: OTHER

i.c.v. infusion of aCSF by an Implanted infusion system

I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.

Intervention Type: OTHER

Other Intervention Names

rhPDGF-BB; Medtronic SynchroMed® II Infusion System; Placebo, Artificial Cerebrospinal fluid; Medtronic SynchroMed® II Infusion System

Eligibility Criteria

Inclusion Criteria

1. Disease duration ≥ 5 years (diagnosis based on medical history and neurological examination).

2. Male or female, age 30 - 75 years inclusive.

3. Motor fluctuations, with OFF-time >1.5 hours during the day

4. A Hoehn and Yahr stage of 2 to 4 during OFF phase

5. Score >22 on the UPDRS part III during ON phase

6. Patients should be L-dopa responsive and demonstrate at least a 30% decrease in the UPDRS part III score after administration of L-dopa (L-dopa challenge test)

7. Optimised and stable anti-Parkinson treatment for at least 3 months before screening

Exclusion Criteria

1. The patient has any indication of forms of parkinsonism other than idiopathic Parkinson's disease

2. The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms

3. Patients who are on treatment with Duodopa or Apomorphine pump at the time of screening

4. The patient has an implanted shunt for the drainage of CSF or an implanted Central Nervous System (CNS) catheter, or have received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the trial period

5. Concurrent diagnoses of dementia with a score of 24 or lower on Mini-Mental State Examination (MMSE).

6. The patient is depressed, as indicated by a Hamilton Depression Rating Scale (GRID-HAMD, 17-item scale) score > 17

7. Patients who are at high risk of suicide as judged by the rating of the Columbia Symptoms Suicide Rating Scale (C-SSRS)

8. Patients with a history of increased intracranial pressure

9. Ophthalmologic examination (funduscopy and visual acuity by Early Treatment of Diabetic Retinopathy Study (EDTRS) and perimetry) with clinically significant findings that imply safety concerns for this study

10. The patient has a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease

11. The patient has heart problems or a significant ECG abnormality

12. Uncontrolled hypertension.

13. The patient has in the past experienced psychotic symptoms (e.g. schizophrenia or psychotic depression)

14. The patient has a mental or physical condition which would preclude performing study assessments

15. Alcohol or substance dependence within the prior 12 months, or abuse within 3 months, with the exceptions of nicotine

16. MRI examination with findings of tumours or potential sources of pathological bleedings, or any abnormality that may put the patient at risk

17. History of structural brain disease including tumours and hyperplasia

18. Ongoing or suspected primary or recurrent malignant disease (currently active or in remission for less than one year)

19. Any disorder that precludes a surgical procedure, alters wound healing or renders chronic i.c.v. delivery or device implants medically unsuitable

20. The patient has a history or a current diagnosis of HIV, Hepatitis B or C.

21. Increased susceptibility to infections

22. Women who are pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

Newron Sweden AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Håkan Widner, Prof

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital

Locations

Klinikum-Bremerhaven

Bremerhaven, , Germany

Lund University Hospital

Lund, , Sweden

Karolinska University Hospital Huddinge

Stockholm, , Sweden

King's College Hospital

London, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Countries

Germany; Sweden; United Kingdom

Other Identifiers

sNN0031-004

Identifier Type: -

Identifier Source: org_study_id