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- ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Essential3: An Innovative Multi-Study Phase 3 Program to Evaluate the Efficacy and Safety of Ulixacaltamide (Poster Hall (Exhibit Hall A)) - Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_840;
P2, P3
In addition to providing evidence of ulixacaltamide safety and efficacy, the Essential3 program is expected to set the foundation for future clinical trial design in ET and other neurologic disorders.
- ||| ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Trial completion, Trial completion date: A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Mar 12, 2024
P2, N=133, Completed, Sponsor: Praxis Precision Medicines
In addition to providing evidence of ulixacaltamide safety and efficacy, the Essential3 program is expected to set the foundation for future clinical trial design in ET and other neurologic disorders. Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Feb 2024
- ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Assessing Clinically Meaningful Improvement Associated with Ulixacaltamide Treatment in Adults with Essential Tremor on Concomitant Propranolol: Findings from Essential1 (Colorado Convention Center | Four Seasons 4) - Mar 8, 2024 - Abstract #AAN2024AAN_4330;
P2
Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Feb 2024 Building on findings from Essential1 and focusing on measures determined to be most meaningful to patients, these results highlight the potential for ulixacaltamide to revolutionize the treatment of ET, with evidence of meaningful improvement both alone and in combination with chronic propranolol use.
- ulixacaltamide (PRAX-944) / Praxis Precision Medicines
An Innovative Multi-study Phase 3 Program to Evaluate the Efficacy and Safety of Ulixacaltamide: The Future of Clinical Trial Design in Essential Tremor (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_2447;
P2, P3
Building on findings from Essential1 and focusing on measures determined to be most meaningful to patients, these results highlight the potential for ulixacaltamide to revolutionize the treatment of ET, with evidence of meaningful improvement both alone and in combination with chronic propranolol use. In addition to providing evidence of ulixacaltamide safety and efficacy, the Essential3 program is expected to set the foundation for future clinical trial design in ET and other neurologic disorders.
- |||||| ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Enrollment open: Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET) (clinicaltrials.gov) - Nov 9, 2023
P3, N=620, Recruiting, Sponsor: Praxis Precision Medicines
In addition to providing evidence of ulixacaltamide safety and efficacy, the Essential3 program is expected to set the foundation for future clinical trial design in ET and other neurologic disorders. Not yet recruiting --> Recruiting
- | ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Trial completion date: A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Oct 18, 2023
P2, N=131, Active, not recruiting, Sponsor: Praxis Precision Medicines
Not yet recruiting --> Recruiting Trial completion date: Sep 2023 --> Dec 2023
- |||||||||| ulixacaltamide (PRAX-944) / Praxis Precision Medicines
New P3 trial: Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET) (clinicaltrials.gov) - Oct 16, 2023
P3, N=620, Not yet recruiting, Sponsor: Praxis Precision Medicines
- ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Patient-Focused, Clinically Meaningful Endpoints as Evidence of Improved Outcomes and Durability of Effect Following Ulixacaltamide Treatment in Adults with Essential Tremor: Findings from Essential1 () - Aug 30, 2023 - Abstract #MDSCongress2023MDS_Congress_2120;
P2
This is the first time an MSD is defined in ET using a large patient dataset and a focus on measures determined to be most meaningful to patients. We highlight mADL11 as a reliable, patientfocused COA related to ulixacaltamide efficacy and durability, with important decision-making implications for ET therapies.
- ulixacaltamide (PRAX-944) / Praxis Precision Medicines
A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Efficacy, Safety and Tolerability of PRAX-944 in Adults with Parkinson (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_1466;
Secondary endpoints will include change from baseline to Day 77 in the MDS-UPDRS Part III tremor sub-score (OFF state) and Part II score; and Patient Global Impression of Severity and Clinician Global Impression of Severity. Conclusions The PRAX-944-231 trial is expected to provide proof-of-concept for use of PRAX-944 in the treatment of PD.
- || ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Enrollment closed, Trial completion date, Trial primary completion date: A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Nov 30, 2022
P2, N=131, Active, not recruiting, Sponsor: Praxis Precision Medicines
Conclusions The PRAX-944-231 trial is expected to provide proof-of-concept for use of PRAX-944 in the treatment of PD. Recruiting --> Active, not recruiting | Trial completion date: Oct 2022 --> Jul 2023 | Trial primary completion date: Sep 2022 --> Feb 2023
- PRAX-944 / Praxis Precision Medicines
A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor (Poster Station: 23) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_934;
P2
Our findings provide preliminary evidence that PRAX-944 can reduce tremor symptoms of ET at well-tolerated doses. Part B topline results are expected in 1H2022 following completion of the randomized withdrawal phase and will inform dose selection in later phase studies.
- PRAX-944 / Praxis Precision Medicines
A Phase 2 Randomized, Double-blind, Placebo-controlled Trial of PRAX-944 for the Treatment of Essential Tremor (Poster Station: 23) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_933;
P2
Expanding on preliminary findings, the Essential1 trial will further examine the safety, tolerability and efficacy of PRAX-944 in adults with ET, and will determine optimal doses and endpoints for evaluation in later phase studies. Importantly, the unique design seeks to address the sub-optimal benefit-risk profile of current therapies and associated unmet needs in ET.
- | PRAX-944 / Praxis Precision Medicines
Journal: Translational Pharmacology of PRAX-944, a Novel T-Type Calcium Channel Blocker in Development for the Treatment of Essential Tremor. (Pubmed Central) - Jun 22, 2022
In rats, PRAX-944 reduced sigma-power at concentrations that reduced tremor without locomotor side effects. In healthy participants, comparable reductions in sigma-power indicate that robust T-type calcium channel blockade was achieved at well-tolerated doses that may hold promise for reducing tremor in patients with essential tremor.
- || ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Trial completion: A Clinical Trial of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Apr 8, 2022
P2, N=24, Completed, Sponsor: Praxis Precision Medicines
In healthy participants, comparable reductions in sigma-power indicate that robust T-type calcium channel blockade was achieved at well-tolerated doses that may hold promise for reducing tremor in patients with essential tremor. Recruiting --> Completed
- | ulixacaltamide (PRAX-944) / Praxis Precision Medicines
New P2 trial: A Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Essential Tremor - Part B (EUDRACT) - Mar 10, 2022
P2, N=12, Recruiting, Sponsor: Praxis Precision Medicines
- PRAX-944 / Praxis Precision Medicines
Translational Pharmacology?of PRAX-944, a Novel T-type Calcium Channel Blocker for the Treatment of Essential Tremor () - Mar 6, 2022 - Abstract #AAN2022AAN_2321;
In rats, PRAX-944 reduced sigma-power at concentrations that reduced tremor without locomotor side-effects. In healthy participants, comparable sigma-power reductions indicate that TTCC blockade was achieved at well-tolerated doses that may hold therapeutic promise for tremor reduction in patients with ET.
- PRAX-944 / Praxis Precision Medicines
PRAX-944-222: A Phase 2 Randomized, Double-blind, Placebo-controlled Trial of PRAX-944 for the Treatment of Essential Tremor ([VIRTUAL]) - Mar 6, 2022 - Abstract #AAN2022AAN_1991;
P2
In healthy participants, comparable sigma-power reductions indicate that TTCC blockade was achieved at well-tolerated doses that may hold therapeutic promise for tremor reduction in patients with ET. Expanding on preliminary findings, the PRAX-944-222 trial will further examine the safety, tolerability and efficacy of PRAX-944 in adults with ET, and will determine optimal doses and endpoints for evaluation in later phase studies. Importantly, the unique trial design seeks to address the sub-optimal benefit-risk profile of current therapies and associated unmet needs in ET.
- PRAX-944 / Praxis Precision Medicines
PRAX-944-221: A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor ([VIRTUAL]) - Mar 6, 2022 - Abstract #AAN2022AAN_1990;
P2
Findings from the PRAX-944-221 trial provide preliminary evidence that PRAX-944 can reduce tremor symptoms of ET at well-tolerated doses. Continuing investigations, including an expanded dose range up to 120 mg daily with a placebo arm (PRAX-944-221 Part B), as well as an 8-week, dose-range finding, placebo-controlled trial (PRAX-944-222, NCT05021991) will determine optimal doses of PRAX-944 for evaluation in later phase studies.
- | ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Trial completion date, Trial primary completion date: A Clinical Trial of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Mar 2, 2022
P2, N=24, Recruiting, Sponsor: Praxis Precision Medicines
Continuing investigations, including an expanded dose range up to 120 mg daily with a placebo arm (PRAX-944-221 Part B), as well as an 8-week, dose-range finding, placebo-controlled trial (PRAX-944-222, NCT05021991) will determine optimal doses of PRAX-944 for evaluation in later phase studies. Trial completion date: Dec 2021 --> Mar 2022 | Trial primary completion date: Dec 2021 --> Mar 2022
- PRAX-944 / Praxis Precision Medicines
Electroencephalographic endpoints as translational central pharmacodynamic biomarkers of the activity of PRAX-944, a novel T-type calcium channel blocker for the treatment of essential tremor (Virtual Only) - Dec 20, 2021 - Abstract #Neuroscience2021Neuroscience_2387;
The comparable reduction in NREM σ-power in humans indicates that robust blockade of T-type Ca 2+ channels was achieved at well-tolerated doses. These findings suggest that the doses of PRAX-944 tested here may hold promise for patients with ET.
- PRAX-944 / Praxis Precision Medicines
Translational pharmacology of PRAX-944: a novel T-type calcium channel blocker for the treatment of essential tremor () - Dec 15, 2021 - Abstract #CNSSUMMIT2021CNS_SUMMIT_100;
In rats, PRAX-944 reduced sigma-power at concentrations that reduced tremor without locomotor side effects. In healthy participants, comparable sigma-power reductions indicate that TTCC blockade was achieved at well-tolerated doses that could hold therapeutic promise for tremor reduction in patients with ET.
- PRAX-944 / Praxis Precision Medicines
A Phase II clinical trial evaluating the efficacy, safety, tolerability, and pharmacokinetics of PRAX-944 in adults with essential tremor () - Dec 15, 2021 - Abstract #CNSSUMMIT2021CNS_SUMMIT_1;
P2
Our findings provide preliminary evidence that PRAX-944 can reduce tremor symptoms in ET at well-tolerated doses. Continuing investigations, including an expanded dose range up to 120mg daily and a placebo arm (Part B), and an eight-week, dose-range finding, placebo-controlled trial (NCT05021991), will determine optimal doses for evaluation in later phase studies.
- ||| ulixacaltamide (PRAX-944) / Praxis Precision Medicines
Enrollment open: A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Oct 31, 2021
P2, N=112, Recruiting, Sponsor: Praxis Precision Medicines
Continuing investigations, including an expanded dose range up to 120mg daily and a placebo arm (Part B), and an eight-week, dose-range finding, placebo-controlled trial (NCT05021991), will determine optimal doses for evaluation in later phase studies. Not yet recruiting --> Recruiting
- || ulixacaltamide (PRAX-944) / Praxis Precision Medicines
New P2 trial: A Clinical Trial of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Aug 25, 2021
P2, N=24, Recruiting, Sponsor: Praxis Precision Medicines
- |||| ulixacaltamide (PRAX-944) / Praxis Precision Medicines
New P2 trial: A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor (clinicaltrials.gov) - Aug 25, 2021
P2, N=112, Not yet recruiting, Sponsor: Praxis Precision Medicines