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Parkinson's DiseasePhase 1NCT01829867

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

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Parkinson's Disease
What is being tested?
sNN0031
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesSweden
Study dates
Apr 2013to Oct 2015
Phase
Phase 1
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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Skåne University Hospital Lund

    Lund, 221 85

  • Karolinska University Hospital Huddinge

    Stockholm, 141 86

Other trials in Sweden

About this study

Official title: 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

Being tested
sNN0031
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

Study groups in NCT01829867
Study groupRoleWhat they receive
sNN0031ExperimentalNot described
Receives: Drug: sNN0031

What is being measured

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

  1. Number of adverse events per participant

    Measured: 12 months

Secondary outcomes (4)

  1. Unified Parkinson's Disease Rating Scale (UPDRS) parts I, II and III

    Measured: Change from baseline to 6 months

  2. Quality of Life assessed by the use of the EQ-5D

    Measured: "Change from baseline to 6 months" and "Change from baseline to 12 months"

  3. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measured: "Change from baseline to 3 months" and "Change from baseline to 6 months" and "Change from baseline to 12 months"

  4. Montreal Cognitive Assessment (MoCA)

    Measured: "Change from baseline to 3 months" and "Change from baseline to 6 months" and "Change from baseline to 12 months"

Timeline

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

  1. First posted11 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

Why it stopped: Issues with development and supply of infusion system for delivery of IMP. Prolonged approval process for the clinical study sNN0031-004.

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829867
Sponsor's protocol ID
sNN0031-003
Status last verified
Jan 2016
First submitted
9 Apr 2013
Last updated
27 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 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 11 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: stopped early, as of the sponsor's last update on 27 Jan 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 was stopped early (reason given: Issues with development and supply of infusion system for delivery of IMP. Prolonged approval process for the clinical study sNN0031-004.). Results are not available in the source record.

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?

Number of adverse events per participant (time frame: 12 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 NCT01829867.

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 27 Jan 2016.

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