Suspended

Safety and Tolerability of sNN0031 in Parkinson's Disease Patients

Study Aim

This phase 1 study aims to evaluate the safety and tolerability of sNN0031 in individuals with Parkinson's disease, focusing on the number of adverse events per participant.

What is being tested

Study of sNN0031 Drug

Drug

Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 55 to 75 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: April 2013

See protocol details

Summary

Principal SponsorNewron Sweden AB

Last updated: January 27, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

This study focuses on Parkinson's disease, a condition that affects the brain and leads to problems with movement. The goal is to test the safety and tolerability of a drug called sNN0031. This drug is administered at a specific dose to individuals living with Parkinson's disease. The study aims to understand how well patients can handle this treatment, as it could potentially help manage the condition better. During the study, participants receive the sNN0031 drug directly into the brain through a method known as intracerebroventricular infusion. The main outcome measured is the number of adverse events each participant experiences. This helps to assess the safety of the drug and its potential side effects.

NCT01829867

Principal SponsorNewron Sweden AB

Last updated: January 27, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesNeurodegenerative DiseasesParkinsonian DisordersParkinson Disease

Criteria

11 inclusion criteria required to participate

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

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

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

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16 exclusion criteria prevent from participating

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

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

Concurrent clinically significant depression with a score of 16 or higher on the MADRS rating scale, equivalent to moderate or severe depression

Concurrent dementia with a score of 20 or lower on the MoCA-test

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Skåne University Hospital Lund

Lund, SwedenOpen Skåne University Hospital Lund in Google Maps

Karolinska University Hospital Huddinge

Stockholm, Sweden

Suspended2 Study Centers