Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System

This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.

Start Date16 Feb 2017

Sponsor / Collaborator

JEM Research Institute

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100 Clinical Results associated with JEM Research Institute

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01 Dec 2023·Alzheimer's & Dementia

Overcoming Recruitment Challenges and Increasing Representation and Diversity of Participation in Early MCI Clinical Trials: The MIND Study Experience

Author: Scharre, Douglas W. ; Aisen, Paul S. S ; Ismail, Andalib ; Turner, R. Scott ; Raman, Rema ; Brody, Mark ; Li, Clara ; Andrews, Patricia ; Goldstein, Mark ; Lewandowski, Agnes ; Newhouse, Paul A ; Szigeti, Kinga ; Mintzer, Jacobo E

AbstractBackgroundThe MIND (Memory Improvement with Nicotine Dosing) study is an ongoing trial to determine whether long‐term transdermal nicotine treatment results in sustained cognitive improvement and attenuation of cognitive decline in patients with MCI. To improve the demographic representation of screened and randomized study participants, the MIND Study Underrepresented Group (URG) Recruitment and Retention (R&R) Initiative was established.MethodThe goal was to increase the screenings and randomizations of participants who self‐report as belonging to an underrepresented race or ethnic group or report a low educational attainment level (high school completion or less). Key elements of the initiative comprised of: (a) financial support of site infrastructure, (b) centralized support with culturally relevant recruitment materials, (c) monthly meetings to secure best practices, and (d) dissemination of successful strategies. Measurement of success included overall screening and randomization rates, as well as qualitative and quantitative metrics reported by initiative sites.ResultNine sites (25% of active study sites) participated in this initiative from March 2022‐February 2023. The first three months required development of site‐specific recruitment plans, goal setting, and needs assessments. During this year, we observed an increase in URG screenings (21.3%) and randomizations (33.3%) (Table 1). Similar increases were observed in race and ethnicity (25.4% and 44% respectively) as well as low educational attainment (21.2% and 31.6% respectively) groups. This initiative improved the overall URG monthly screening from 2.23/month prior to the initiative to 2.42/month during the initiative and the monthly randomization rate from 0.93/month to 1.58/month. Site‐reported data on the pre‐screening activity indicated that the main reasons for pre‐screen fails were participants either not belonging to an URG (56%) or not meeting MCI criteria (20%). Concerns around study burden, study partner availability and nicotine were reported in less than 10% of the pre‐screened individuals.ConclusionThis initiative successfully increased the representation of screened and randomized MIND Study participants with respect to self‐reported race, ethnicity, and educational level. Initial success suggests that a multifaceted approach coordinated through close collaborations between sites and the central coordinating center are necessary to screen and randomize representative populations in early MCI trials.

01 Aug 2023·Neurology Clinical Practice

A Pilot Study

Article

Author: Klos, Kevin ; Zhang, Yi ; Goldstein, Mark ; Navia, Bradford ; Singer, Carlos ; Pucci, Michael ; Koblan, Kenneth S. ; Crandall, David ; Isaacson, Stuart H. ; Pahwa, Rajesh

Background and ObjectivesUlotaront (SEP-363856) is a trace amine-associated receptor 1 agonist with 5-HT_1A receptor agonist activity currently in phase 3 clinical development for the treatment of schizophrenia. In this exploratory, flexibly dosed study, ulotaront was evaluated for the treatment of Parkinson disease psychosis (PDP).MethodsPatients with PDP requiring antipsychotic therapy were randomized, double-blind to ulotaront (25, 50, or 75 mg/d) or placebo. Mixed Model for Repeated Measures was used to assess change from baseline in the Scale for the Assessment of Positive Symptoms for Parkinson Disease (SAPS-PD) at 6 weeks (primary end point).ResultsThe efficacy analysis sample comprised 38 patients (ulotaront, n = 24; placebo, n = 14). SAPS-PD total scores were numerically reduced in ulotaront-treated vs placebo-treated patients from week 1 to week 6: Least squares mean (95% confidence interval) difference in change from baseline at week 6 was -1.1 (-6.5, 4.3, p = 0.681). PDP symptom complete remission (≥100% improvement [reduction] from baseline in SAPS-PD total score) was observed in 25% of ulotaront-treated vs 0% of placebo-treated patients. SAPS-PD and Neuropsychiatric Inventory hallucinations subscales were numerically reduced vs placebo, and SAPS-PD total scores were reduced in patients with greater cognitive impairment (baseline Mini-Mental State Examination [MMSE] scores ≤24). Ulotaront improved Scales for Outcomes in Parkinson Disease Sleep Scale - Daytime Sleepiness scores (p = 0.022). There was no worsening of Unified Parkinson Disease Rating Scale Part III motor score, MMSE, or vital signs. Adverse events (≥10%) with ulotaront vs placebo included hallucinations (24% vs 14%), confusional state (20% vs 14%), dizziness (16% vs 7%), nausea (12% vs 7%), and falls (12% vs 21%).DiscussionIn this exploratory pilot study, ulotaront may decrease PDP symptoms without worsening motor function, particularly in patients with cognitive impairment.Trial Registration InformationClinicalTrials.gov identifier: NCT02969369; submitted: November 17, 2016; study start date: December 31, 2016.Classification of EvidenceThis Class II study was an exploratory pilot study that was underpowered to detect a statistically significant difference between ulotaront and placebo in the treatment of patients with Parkinson disease psychosis without worsening motor function.

24 Sep 2020·Restorative Neurology and NeuroscienceQ4 · MEDICINE

A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke

Q4 · MEDICINE

Article

Author: Finklestein, Seth P. ; Wilson, Christina A. ; Page, Stephen J. ; Roberts, Holly ; Kasner, Scott E. ; Ning, MingMing ; Bockbrader, Marcia ; El-Feky, Waleed H. ; Goldstein, Mark

Background: Stroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery. Objective: Based on promising preliminary data, we compared efficacy of D-ER administered at 7.5 mg or 10 mg with placebo on post-stroke ambulation. Primary study outcome (response) was a ≥20% increase on the 2-minute walk test (2 MinWT) at 12 weeks after first drug administration. Methods: This was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2 MinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1:1:1 to receive 7.5 mg D-ER, 10 mg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug. Results: The study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3 study groups (14.9±40.0 feet; 19.4±39.6 feet; and 20.4±38.3 feet for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively). The proportion of subjects who showed ≥20% improvement on 2 MinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively; these were nonsignificant changes from baseline for all groups. Conclusions: D-ER at either a 7.5-mg or 10-mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).

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