Allon Phase 2/3 Study in Progressive Supranuclear Palsy AL-108-231 V1
A Phase 2/3, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy.
Allon Therapeutics Inc
The purpose of this Phase 2/3 study is to find out what effects Davunetide given intranasally (in the nose by nasal spray) has on subjects diagnosed with progressive supranuclear palsy (PSP). The study will be placebo-controlled. A placebo is a dummy drug with no effect other than to appear like the study drug. There is a 50/50 chance of getting study drug or placebo. Davunetide is an experimental drug. This study will help determine whether Davunetide is safe and if it has any impact on PSP. It is intended to recruit around 300 patients globally of which a maximum of approximately 20 are intended to come from the UK. There will first be a â€œscreeningâ€ period that will last up to 4 weeks. During that time the following exams, tests or procedures will be done to determine if a subject is suitable to be in the main part of the study: Medical history: Physical and neurological examination: Subjects will have a physical examination and some evaluations that relate specifically to PSP. Electrocardiogram: Memory and cognitive testing: Vital signs: Blood and urine sampling (Venepuncture): Genetic Sample Analysis (Optional): MRI scan. Lumbar Puncture (optional) The main part of the study will consist of 7 further visits over 52 weeks. Study drug/Placebo will be dosed daily by the patient or if necessary, their caregiver During each visit except Visit 8, which is a telephone interview, tests to determine safety and effectiveness and tolerability of the study drug will include: Symptom and medication review vital signs: . Nasal Examination: Blood and urine samples: Study Questionnaires and Memory/ Cognitive Testing A repeat MRI scan will be done at 52 weeks of the study and compared with the baseline scan to determine the extent of brain atrophy (wasting)over the study period. A repeat Lumbar Puncture will be carried out at 52 weeks.
North East - Newcastle & North Tyneside 1 Research Ethics Committee
Date of REC Opinion
22 Dec 2010
Further Information Favourable Opinion