A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.

January 26, 2016 updated by: Newron Sweden AB

A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 μg by Intracerebroventricular Infusion

The purpose of this study is to assess the safety and tolerability of a dose of 95μg sNN0031 after intracerebroventricular administration to patients with Parkinson's disease

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Skåne University Hospital Lund
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient has a diagnosis of idiopathic PD
  • Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns defined as being any drug-related or device related SAE that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001 and sNN0031-002
  • Inclusion in study sNN0031-002 and participation without development of clinically significant safety concerns defined as being device related SAE that resulted in premature termination or a medical device incident that could not be resolved during the conduct of study sNN0031-002
  • Intact continuity of the SynchroMed® II pump and ICV-catheter infusion system as judged by X-ray of head and abdominal area
  • An ICV catheter tip position that is similar to the catheter tip position at implantation in study sNN0031-001, as verified with an MRI not older than 3 months
  • Verification of device function made as a comparison of pump actual residual volume to the anticipated residual volume as indicated by the programmer. Reference point will be the refill volume and programming of the pump made at first visit with saline refill in study sNN0031-002. Values within 25% of expected will be an indication that the pump is functioning properly
  • Ophthalmologic examination with no clinically significant findings that imply safety concerns for this study such as retinal haemorrhage, signs for papillary oedema
  • Females should either be post-menopausal (at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with follicle stimulating hormone levels >40 mIU/mL), be surgically sterilised (bilateral oophorectomy without 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
  • The patient, with or without the help of a caregiver, must be capable of maintaining an accurate and complete symptom diary and to adhere to visit schedules
  • The patient has been given written and verbal information about the study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments
  • The patient has provided written informed consent to participate in the study before any study-specific procedures are conducted

Exclusion Criteria:

  • Participation in another clinical study that entails investigational drug or device treatment after participation in study sNN0031-001 or study sNN0031-002
  • The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation)
  • Concurrent dementia with a score of 20 or lower on the MoCA-test
  • 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 from the baseline visit of this study
  • History of structural brain disease including tumours and hyperplasia
  • Ongoing or suspected primary or recurrent malignant disease
  • History of increased intracranial pressure
  • Uncontrolled hypertension with blood pressure >160 mmHg systolic or >90 mmHg diastolic.
  • Completion of an MRI examination of the brain and cervical spinal cord within 3 months prior to study start with finding of tumours or potential sources of pathological bleedings, or abnormality that may or would interfere with the assessments of safety or efficacy, in the judgment of the Investigator
  • Presence of cardiac pacemakers, spinal cord stimulators, implantable programmable intraspinal drug pumps, or any other device that may interfere or interact with the programmer
  • Clinically significant abnormalities in haematology or clinical chemistry parameters indicative of a medical condition requiring treatment which, in the opinion of the Investigator, is not compatible with participation in the present study
  • Ongoing medical condition that according to the Investigator would interfere with the conduct and assessments in the study. Examples are medical disability (e.g., 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 patient to undergo study procedures (e.g., MRI), to maintain a patient diary or to give informed consent.
  • Serological evidence of HBV, HCV or HIV.
  • Tuberculosis (TB) as detected by positive findings in chest X-ray and microscopy of urine.
  • Increased susceptibility to infections (e.g. malignancies, neutropenia, immunodeficient states, immunosuppressive therapy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: sNN0031
Drug: sNN0031

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of adverse events per participant
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) parts I, II and III
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months
Quality of Life assessed by the use of the EQ-5D
Time Frame: "Change from baseline to 6 months" and "Change from baseline to 12 months"
"Change from baseline to 6 months" and "Change from baseline to 12 months"
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: "Change from baseline to 3 months" and "Change from baseline to 6 months" and "Change from baseline to 12 months"
"Change from baseline to 3 months" and "Change from baseline to 6 months" and "Change from baseline to 12 months"
Montreal Cognitive Assessment (MoCA)
Time Frame: "Change from baseline to 3 months" and "Change from baseline to 6 months" and "Change from baseline to 12 months"
"Change from baseline to 3 months" and "Change from baseline to 6 months" and "Change from baseline to 12 months"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Newron Sweden AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gesine Paul-Visse, Skånes University Hospital Lund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • sNN0031-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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