Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis
- Conditions
- ALSAmyotrophic Lateral Sclerosis10029317
- Registration Number
- NL-OMON37243
- Lead Sponsor
- GlaxoSmithKline BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
• Diagnosis of familial or sporadic ALS (see protocol page 29 for details).
• Onset of muscle weakness no more than 30 months before screening visit.
• SVC of at least 65%.
• If on riluzole, the dose must have been stable for at least 28 days.
• Age 18 - 80 years inclusive.
• Females of childbearing potential: reliable method of contraception.
• Other neuromuscular disorders (including a history of polio), which in the opinion of the investigator could have contributed to symptoms or could interfere with study evaluations.
• Primary lateral sclerosis, monomelic ALS, ALS Parkinsonism dementia complex.
• Patients requiring non-invasive or mechanical ventilation.
• Diaphragmatic pacing.
• Significant suicide risk.
• Vaccination within 2 weeks.
• Chronic (>3 months) use of systemic immunosuppressants including systemic steroids.
• Pregnancy or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>ALSFRS-R (ALS functional rating scale-revised).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Major secondary variables: adverse events, vital capacity, muscle strength,<br /><br>overall survival, progression free survival, immunogenicity and PK.</p><br>