Completed Clinical Research

2024

Perspective Program (Sage Studies)Sage Therapeutics Logo

The PERSPECTIVE Program was a set of clinical trials performed to evaluate the safety and effect of SAGE-718 (Dalzanemdor) on cognitive function and functionality in adults with HD. The program is comprised of 3 clinical research studies:

  • DIMENSION Study: 20 weeks
  • SURVEYOR Study: 6 weeks
  • PURVIEW Study: 1 – 1.5 years

DIMENSION: A Study to Evaluate the Effect of SAGE-718 (Dalzanemdor) on Cognitive Function in Participants with Huntington’s Disease 

Phase 2 trial evaluating the efficacy of dalzanemdor in improving cognitive performance and functioning in patients with HD. The study did not meet its primary endpoint, as it failed to demonstrate a statistically significant difference from placebo in the change from baseline on the Symbol Digit Modalities Test (SDMT) at Day 84. Similarly, analyses of secondary endpoints did not show statistically significant or clinically meaningful differences between participants treated with dalzanemdor and those receiving placebo. The study drug was generally well-tolerated, with no new safety signals observed.

SURVEYOR: 28-Day Study of SAGE-718 on Functioning Capacity in Participants with Huntington’s Disease

Similar to the DIMENSION study, this Phase 2 trial evaluated the impact of dalzanemdor on cognitive function in patients with HD. However, this was a smaller study, with three key objectives: (1) to quantify cognitive impairment in HD compared to healthy participants, (2) to assess the safety of dalzanemdor in individuals with HD, and (3) to explore the relationship between cognitive and functional changes. Cognition was assessed using the HD-Cognitive Assessment Battery (HD-CAB), a composite of six tests measuring cognitive domains relevant to HD. First, all participants completed the HD-CAB tests to compare cognitive performance between those with and without HD. Then, participants with HD were randomized into two groups—one receiving for 28 days and the other receiving a placebo. These were the key findings: 1) HD-CAB confirmed cognitive impairment in HD, supporting its use as a meaningful trial measure beyond motor symptoms. 2) Dalzanemdor was well tolerated, with only mild to moderate side effects and no new safety concerns. 3) Possible cognitive benefits were observed, but the study was not designed to assess efficacy, so further analysis was needed.

PURVIEW: A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants with Huntington’s Disease

Phase 3, open-Label study designed for individuals who had completed either the DIMENSION or SURVEYOR trials to assess the long-term safety and tolerability of dalzanemdor in individuals with HD. However, after the DIMENSION study failed to show a statistically significant improvement in cognitive function with dalzanemdor compared to placebo, Sage Therapeutics discontinued further development of the drug, leading to the termination of the PURVIEW study.

Click Here to read the press release.

2023

KINECT-HDKINECT-HD logo

Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington Disease

For more information visit clinicaltrials.gov.

Outcome: The KINECT-HD study tested a drug called valbenazine to see if it could help reduce chorea in people with Huntington’s disease. The study showed that valbenazine really helped decrease chorea symptoms compared to a placebo. People taking the drug showed less severe involuntary movements after 12 weeks, and improvements started to kick in as early as 2 weeks into treatment and continued through the study. The most common side effect was sleepiness (about 16% of people taking the drug reported it). Other side effects included tiredness, dizziness, and restlessness, but those were usually mild to moderate.

Furr Stimming E, Claassen DO, Kayson E, Goldstein J, Mehanna R, Zhang H, Liang GS, Haubenberger D; Huntington Study Group KINECT-HD Collaborators. Safety and efficacy of valbenazine for the treatment of chorea associated with Huntington’s disease (KINECT-HD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2023 Jun;22(6):494-504. doi: 10.1016/S1474-4422(23)00127-8. pubmed.ncbi.nlm.nih.gov/37210099