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Sponsors and Collaborators: |
NeuroNova AB Medtronic Quintiles |
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Information provided by: | NeuroNova AB |
ClinicalTrials.gov Identifier: | NCT00866502 |
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.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety 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. |
Estimated Enrollment: | 12 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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sNN0031: Experimental
Continuous ICV infusion at one of three dose levels
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Drug: Placebo
Continuous ICV infusion
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Placebo: Placebo Comparator |
Drug: Placebo
Continuous ICV infusion
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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.
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sven Pålhagen, MD | movementdisorder@karolinska.se |
Sweden | |
Karolinska University Hospital, Huddinge | Recruiting |
Stockholm, Sweden, 141 86 | |
Principal Investigator: Sven Pålhagen, MD | |
Lund University Hospital | Recruiting |
Lund, Sweden, 22185 | |
Principal Investigator: Håkan Widner, MD |
Principal Investigator: | Sven Pålhagen, MD | Karolinska University Hospital, Huddinge, Sweden |
Responsible Party: | NeuroNova AB ( Markus Jerling, Chief Medical Officer ) |
Study ID Numbers: | sNN0031-001, Q-26239 |
Study First Received: | March 18, 2009 |
Last Updated: | March 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00866502 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
Parkinson Safety PDGF |
Intracerebroventricular Infusion Device |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |