October 26, 2015
Neurocrine Biosciences has issued results of
a phase III study of NBI-98854 for moderate to
severe tardive dyskinesia patients with underlying
schizophrenia, schizoaffective disorder,
bipolar or major depressive disorder. The Kinect 3
study was a randomized, parallel-group, double-blind,
placebo-controlled trial and randomized
234 subjects to either placebo, once-daily 40mg
of NBI-98854 or once-daily 80mg of NBI-98854
for six weeks. Subsequent to the completion
of the six-week, placebo-controlled dosing,
all subjects are placed on once-daily 40mg or
once-daily 80mg of NBI-98854 through week
48. The pre-specified primary efficacy endpoint
was the change from baseline in the Abnormal
Involuntary Movement Scale (AIMS) at week six
in the 80mg once-daily dosing group compared
to placebo as assessed by central blinded video
raters. The AIMS ratings at week six for the 80mg
once-daily NBI-98854 intention-to-treat population
was reduced 3.1 points (Least-Squares
Mean) more than placebo (p<0.0001). NBI-98854
was generally well-tolerated. The frequency of
adverse events was similar among all treatment
groups and treatment emergent adverse effects
were consistent with those of prior studies. In addition
to Kinect 3, a separate one-year open-label
safety study of NBI-98854, Kinect 4, also has been
initiated to support the anticipated 2016 filing of
a NDA in tardive dyskinesia anticipated to be filed
March 26, 2012
Addex Therapeutics issued results from a phase IIa trial of dipraglurant for the treatment of Parkinsons disease levodopa-induced dyskinesia (PD-LID). This double-blind, placebo-controlled study enrolled 76 subjects with moderate or severe PD-LID. The subjects followed a dose-titration regimen, receiving 50mg doses from day 1 to day 14 and then 100mg from day 14 until day 28. Dipraglurant met the primary objective of the study by exhibiting a good safety and tolerability profile. Dipraglurant also demonstrated statistically significant reduction in LID severity with both 50mg and 100mg doses. Efficacy was measured using the modified Abnormal Involuntary Movement Scale (mAIMS). Peak mAIMS was significantly reduced on Day 1 (50mg; p≡0.042) and on Day 14 (100mg; p≡0.038).
December 13, 2010
Nueraltus issued positive results from a phase I/II trial of NP002 for the treatment of dyskinesias resulting from levodopa therapy for Parkinson's disease. This randomized, double-blind, parallel group, placebo controlled trial enrolled 65 subjects. NP002 was administered concurrently with levodopa in escalating doses from 1 mg to 6 mg, four times a day. Each dose was taken for two weeks, except the highest dose, which was taken for four weeks. Clinically relevant trends and, in two cases, statistical superiority of NP002 over placebo were observed in a variety of physician- and patient-rated efficacy outcome measures relating to dyskinesias. The combination was found to be generally safe and well-tolerated.
June 11, 2007
Faust reported positive results from a phase IIa trial of FP0011 for the treatment of Parkinson’s disease. This randomized, blinded trial enrolled 8 subjects with L-dopa-induced motor complications. Subjects were administered FP0011 or placebo over 4 cross-over periods. Treatment was well tolerated. Parkinson’s symptoms, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), showed positive improvement. The effects were observed in three areas: "core" Parkinsonian motor symptoms, axial symptoms not sensitive to L-dopa or other dopaminergic drugs and dyskinesia. Based on these results, phase IIb trials are being planned for the near future.
October 3, 2005
Neurologix issued positive interim results of a phase I trial of their AAV-GAD viral-vector gene therapy, for the treatment of Parkinson's disease (PD), at the 19th Annual Symposia on the Etiology, Pathogenesis and Treatment of Parkinson's Disease and Other Movement Disorders in San Diego. Primary safety data yielded a positive overall tolerability profile. Preliminary efficacy data were also positive, with a statistically significant 27% improvement in symptom severity score on the side of the body corresponding to the treated part of the brain, as measured on the Unified Parkinson Disease Rating Scale, relative to baseline (p=0.04); the untreated side experienced no significant improvement. Significant decreases in the extent of abnormal metabolism associated with the disease were also noted in drug-treated portions of the brain vs. baseline; the corresponding structure in the untreated side of the brain experienced progressive increases in abnormal function. This open-label dose- escalation study enrolled 12 PD patients, who received one of 3 single doses of the gene therapy (3.5, 10 or 35 billion viral particles) via unilateral intracerebral catheter infusion into the subthalamic nucleus, followed by observational follow-up at 1, 3, 6 and 12 months.
August 11, 2003
Acadia Pharmaceuticals reported positive results from a phase I trial investigating ACP-103, a 5-HT2A inverse agonist for the treatment of various neuropsychiatric conditions. Results demonstrated that ACP-103 was safe and well tolerated with dose proportional pharmacokinetics and a long half-life. Data also demonstrated that ACP-103 was well tolerated with no changes in cardiovascular and neurological function and no serious adverse events. The randomized, double blind, placebo-controlled, dose-escalation study enrolled 49 subjects and used both single-dose and multiple-dose regimens. The single-dose study evaluated five doses ranging from 20 to 300 mg and the multiple dose-escalation study evaluated oral doses of 50, 100, and 150 mg given once-daily for 14-days.