- Sage today announced top-line results from an open-label Phase 2 clinical trial of SAGE-217 in patients with tremor-predominant Parkinson’s disease.
- Part B of the exploratory study evaluated SAGE-217 as an adjunctive treatment for seven days in 14 tremor-predominant Parkinson’s disease patients who were on stable doses of anti-Parkinsonian agents.
- SAGE-217 improved tremor symptoms, as assessed by the MDS-UPDRS - Part II/III tremor score, by a mean change of 7.7 points (40.0%) by Day 8 from a mean baseline score of 19.1 points, which was the primary efficacy endpoint in the Part B study.
- Additional secondary efficacy endpoints were consistent with the primary efficacy endpoint. SAGE-217 improved overall Parkinson’s disease motor symptoms, as assessed by the MDS-UPDRS Part III motor score, by a mean change of 18.6 points (36.3%) by Day 8 from a mean baseline score of 52.4 points.
- SAGE-217 also improved symptoms of sleep dysfunction in five patients with clear sleep dysfunction at baseline, as assessed by the Parkinson’s Disease Sleep Scale (PDSS-2) score, by a mean change of 12.2 points (41.2%) by Day 8 from a mean baseline score of 29.8 points.
- Administration of SAGE-217 in the evening was generally well-tolerated with no serious adverse events or discontinuations reported. The most common adverse events were dizziness, sedation, and somnolence, each occurring in two patients.
- Sage believes the results from this open-label Phase 2 trial support further clinical development, and that the data from this study will provide guidance on methodology, dosing, and design for a future placebo-controlled Phase 2 clinical trial in Parkinson’s disease.
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Phase 2 Open-Label Data Evaluating SAGE-217 in Parkinson's Disease Due H1 2017
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Related Keywords Phase 2, Open-label Data, Sage-217, Parkinson's Disease