Neurocrine Biosciences has announced that its Phase 3 KINECT-DCP trial testing valbenazine in pediatric and adult patients with dyskinetic cerebral palsy (DCP) failed to meet its primary and key secondary endpoints. The study aimed to assess improvement in chorea, a type of involuntary movement common in DCP.

"These results are disappointing, as there are no approved treatments for people living with dyskinetic cerebral palsy," said Sanjay Keswani, Chief Medical Officer, Neurocrine Biosciences. "We are deeply grateful to the patients and their families, as well as the investigators and site staff, whose commitment, dedication, and participation made this clinical trial possible."

The trial, the largest double-blind, placebo-controlled study ever conducted in DCP, tested 14 weeks of valbenazine against placebo in participants aged 6 to 70 with choreiform movements caused by cerebral palsy. Adverse events were consistent with valbenazine’s established safety profile. 

DCP is a severe form of cerebral palsy that affects roughly 15% of the 3 per 1,000 children born with CP in the U.S. Patients experience mixed hyperkinetic movements, including dystonia and choreoathetosis, causing significant motor impairment. No treatments are currently approved for these symptoms.

Valbenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, was first approved in 2017 to treat tardive dyskinesia and later in 2023 for chorea in Huntington’s disease. Neurocrine is also developing next-generation VMAT2 inhibitors, including NBI-1065890, which is entering Phase 2 development for tardive dyskinesia in 2026.