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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829867
Recruitment Status : Terminated (Issues with development and supply of infusion system for delivery of IMP. Prolonged approval process for the clinical study sNN0031-004.)
First Posted : April 11, 2013
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Newron Sweden AB

Brief 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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: sNN0031 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sNN0031 Drug: sNN0031



Primary Outcome Measures :
  1. Number of adverse events per participant [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) parts I, II and III [ Time Frame: Change from baseline to 6 months ]
  2. 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" ]
  3. 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" ]
  4. 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" ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829867


Locations
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Sweden
Skåne University Hospital Lund
Lund, Sweden, 221 85
Karolinska University Hospital Huddinge
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Newron Sweden AB
Investigators
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Principal Investigator: Gesine Paul-Visse Skånes University Hospital Lund
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Responsible Party: Newron Sweden AB
ClinicalTrials.gov Identifier: NCT01829867    
Other Study ID Numbers: sNN0031-003
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases