Clinical Trials Resource Center


October 10, 2016

Teva Pharmaceutical Industries issued results of a phase III trial of SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD). AIM-TD was a phase III, randomized, double-blind, placebo-controlled, parallel group, fixed-dose study of 288 male and female adults with moderate to severe TD. All patients had a total motor AIMS=6 at screening and were randomized at baseline in a 1:1:1:1 ratio to receive one of three fixed-dose regimens of deutetrabenazine (12mg/day, 24mg/day, 36mg/day) or placebo. Patients underwent dose escalation during the initial four weeks, followed by an eight-week maintenance period and a one-week washout. At week 12, the AIMS rating improved from baseline by -3.3 points for 36mg (p=0.001), -3.2 points for 24mg (p=0.003) and -2.1 for 12mg (p=NS), compared to -1.4 in placebo. In addition to the primary endpoint, mean scores on the Clinical Global Impression of Change (CGI) improved by -0.5 for 36mg (p=0.011) and by -0.6 for 24mg (p=0.002) based on the modified intent-totreat population. The CGI is a global assessment of the patient’s abnormal movements made by the treating investigator. For the protocol-specified secondary endpoint of CGI, in which treatment success was defined as “much improved” or “very much improved” at week 12 and missing data were counted as treatment failure, 24mg was superior to placebo (p=0.014); the 36mg dose was superior to placebo, but did not reach statistical significance (p=0.059). Teva expects to make a regulatory submission to the FDA by the end of 2016.

October 3, 2016

Adamas Pharmaceuticals released results of the EASE LID 3 study, the second phase III trial of ADS-5102 (amantadine hydrochloride) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD). The trial met its primary endpoint, the reduction of the UDysRS (Unified Dyskinesia Rating Scale) total score at week 12 (p<0.0001), reflecting a decrease in the duration, intensity and disability associated with LID. Results showed a statistically significant reduction (p=0.0009) in LID at 12 weeks for patients who received ADS-5102 versus placebo as assessed by the UDysRS. This represents a 23% reduction in LID for ADS-5102-treated patients compared to placebo. The reduction in LID was maintained at 24 weeks (p=0.0008), a key secondary analysis. In this study, there were four additional key secondary analyses based on patient diary data. All achieved statistical significance. A statistically significant reduction in OFF time (a key secondary endpoint) was observed, as measured by patient reported home diaries. Notably, at week 12, ADS-5102 significantly increased ON time without troublesome dyskinesia by 2.7 hours versus placebo and reduced OFF time by 0.9 hours. These effects were maintained at week 24. The company will submit a New Drug Application for ADS-5102 to the FDA later this year.

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 in 2016.

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.

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