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Parkinson's DiseasePhase 1/2NCT00866502

A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

A Phase 1/2 study testing sNN0031 in people with Parkinson's Disease, run by Newron Sweden AB at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
sNN0031
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
2 sitesSweden
Study dates
Mar 2009to Mar 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female. Females should either be post-menopausal (at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with FSH levels >40 mIU/mL), be surgically sterilized (bilateral oophorectomy w/o hysterectomy), or use adequate contraception (oral contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.) during the duration of the study.
  • Diagnosis of idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn \& Yahr Stage IIb-III).
  • Effect duration of oral L-dopa dose intake ≤4 hours
  • Score ≥30 on motor part (part III) of UPDRS at defined off (>12 hours after last dose intake)
  • Dopaminergic responsiveness with at least 33% decrease in the UPDRS part III score after administration of L-dopa
  • Disease duration at least 5 years
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  • Age 30 to 75 years
  • Stable anti-Parkinson treatment for at least 3 months
  • Ophthalmologic examination with normal findings regarding vascular structure and function
  • MRI examination of the brain and cervical spinal cord within 3 months before anticipated implantation of the device with no findings of tumors or potential sources of pathological bleedings, or abnormality that may interfere with the assessments of safety or efficacy or would, in the judgment of the investigator, represent a surgical risk to the subject.
  • Values of coagulation parameters including platelet count, normalized prothrombin complex (PK-INR), activated partial thromboplastin time (APTT) within normal ranges.
  • The subject is medically able to undergo the surgery required for stereotactic implantation of the catheter and infusion pump.
  • Has been given written and verbal information, has had opportunity to ask questions about the study, and understands time and procedural commitments
  • Signed consent (written) to participate in the study

Who cannot join

  • Atypical form of PD including repeated head trauma, drug- or toxin-induced PD, and other neurological conditions including Shy-Drager syndrome (multiple system atrophy), progressive supranuclear palsy, Wilson's disease, Huntington's disease, Hallervorden-Spatz syndrome, Alzheimer's disease, Creutzfeldt-Jakob disease, olivopontocerebellar atrophy, and post-traumatic encephalopathy
  • Concurrent dementia with a score of 20 or lower on the MMT rating scale
  • Concurrent clinically significant depression with a score of 16 or higher on the MADRS rating scale, equivalent to moderate or severe depression.
  • Exposure to neuroleptic drugs blocking dopamine receptors within 6 months
  • History of structural brain disease including tumors and hyperplasia
  • History of increased intracranial pressure
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  • Prior surgical procedures or implantation of device for the treatment of PD
  • Prior exposure to any formulation of PDGF-BB (including topical)
  • Uncontrolled hypertension with blood pressure >160 mmHg systolic or >90 mmHg diastolic.
  • Any disorder that precludes a surgical procedure (eg, signs of sepsis or inadequately treated infection), alters wound healing (e.g. including bleeding disorders), or renders chronic ICV delivery or device implants medically unsuitable.
  • Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally. Physicians should specifically investigate anatomical factors at or near the implant site (e.g., vascular abnormalities, neoplasms, or other abnormalities), underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., hemophilia, Von Willebrand's disease, liver disease, or other medical conditions), and the administration of any antiplatelet or anticoagulant medication (e.g., aspirin, Plavix, NSAIDs) in the pre- or perioperative period. Any of those conditions or drugs could place a patient at an increased risk for intraoperative or postoperative bleeding.
  • Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or an implanted central nervous system (CNS) catheter.
  • Presence of cardiac pacemakers, spinal cord stimulators, implantable programmable intraspinal drug pumps, or any other device that may interfere or interact with the programmer, without prior approval by Medtronic.
  • Clinically significant abnormalities in hematology or clinical chemistry parameters as assessed by the investigator
  • Ongoing medical condition that according to the investigator would interfere with the conduct and assessments in the study. Examples are medical disability (eg, severe degenerative arthritis, compromised nutritional state, peripheral neuropathy) that would interfere with the assessment of safety and efficacy of investigational product or device performance, or would compromise the ability of the subject to undergo study procedures (eg, MRI, PET), or to give informed consent.
  • Participation in another clinical trial with an investigational drug or device within 3 months prior to Screening visit.

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Lund University Hospital

    Lund, 22185

  • Karolinska University Hospital, Huddinge

    Stockholm, 141 86

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump.

This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.

Read the detailed description

Tremor, rigidity, slow movement, poor balance, and difficulty walking are characteristic symptoms of Parkinson's disease (PD) that are associated with degeneration of dopamine-producing nerve cells in the brain. Administration of growth factors that stimulate neuronal stem and progenitor cells is one possible approach to restore the dopaminergic activity. The drug product sNN0031 containing the endogenous growth factor PDGF has been demonstrated to reduce the typical symptoms in animal models of PD.

NeuroNova intends to investigate whether intracerebroventricular administration of PDGF in the form of the drug product sNN0031 can improve motor function in patients with PD. In this first study the safety and tolerability of treatment for 2 weeks followed by 10 weeks follow-up will be evaluated.

Being tested
sNN0031, Placebo
Keywords
Parkinson, Safety, PDGF, Intracerebroventricular, Infusion, Device
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sNN0031Drug

    Also called PDGF

    Continuous ICV infusion for two weeks

  • PlaceboDrug

    Also called Artificial CSF

    Continous ICV infusion

Study groups in NCT00866502
Study groupRoleWhat they receive
sNN0031ExperimentalContinuous ICV infusion for two weeks at one of three dose levels
Receives: Drug: sNN0031
PlaceboPlacebo comparatorContinuous ICV infusion
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability through assessment of adverse events, ECGs, vital signs, clinical laboratory variables, MRI of brain and spinal cord, CSF sampling, and device performance as characterized by catheter tip placement and infusion accuracy.

    Measured: Multiple over 3 months

Secondary outcomes (2)

  1. Time course of PD disease activity as measured by the UPDRS, MADRS and MMT rating scales.

    Measured: Multiple over 3 months

  2. Change in caudate and putamen dopamine turnover using PET scans of 11C-PE2I uptake

    Measured: Baseline and at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866502
Sponsor's protocol ID
sNN0031-001
Other IDs
Q-26239
Status last verified
Jan 2015
First submitted
18 Mar 2009
Last updated
12 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Paul G, Zachrisson O, Varrone A, Almqvist P, Jerling M, Lind G, Rehncrona S, Linderoth B, Bjartmarz H, Shafer LL, Coffey R, Svensson M, Mercer KJ, Forsberg A, Halldin C, Svenningsson P, Widner H, Frisen J, Palhagen S, Haegerstrand A. Safety and tolerability of intracerebroventricular PDGF-BB in Parkinson's disease patients. J Clin Invest. 2015 Mar 2;125(3):1339-46. doi: 10.1172/JCI79635. Epub 2015 Feb 17.

    PubMed 25689258

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing sNN0031 in people with Parkinson's Disease, run by Newron Sweden AB at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability through assessment of adverse events, ECGs, vital signs, clinical laboratory variables, MRI of brain and spinal cord, CSF sampling, and device performance as characterized by catheter tip placement and infusion accuracy. (time frame: Multiple over 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00866502, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.

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