Clinical Trials and Research

Active Clinical Trials

 

NIH U54 Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias, LeDoux- Site PI, 01MAY2011 – present.

Parkinson’s Foundation, Trial of Parkinson’s and Zoledronic Acid (TOPAZ), LeDoux – Site PI, 04DEC2019 – present.

Neurocrine Biosciences, Inc., “OPTI-ON: Opicapone Treatment Initiation Open-Label Study”, LeDoux- Site PI, 08JAN2021 – present.

Aeon Biopharma, Inc., “A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intramuscular ABP-450 (prabotulinumtoxinA) injection for the Treatment of Cervical Dystonia, ABP-19000”, LeDoux – Site PI, 25JAN2021 – present.

Aeon Biopharma, Inc., “An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Repeat Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia”, LeDoux – Site PI, 25JAN2021 – present.

Cerevel, “A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of TAVAPADON in Early Parkinson’s Disease (TEMPO-2 Trial)”, LeDoux – Site PI, 25JAN2021 – present.

Cerevel, “A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of TAVAPADON as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults with Motor Fluctuations (TEMPO-3 Trial)” LeDoux – Site PI, 25JAN2021 – present.

Cerevel, “58 Week Open-Label Trial of TAVAPADON in Parkinson’s Disease (TEMPO-4 Trial)”, LeDoux – Site PI, 25JAN2021 – present.
 

Recent Publications

LeDoux MS. Population Prevalence of Deleterious SGCE Variants. Tremor Other Hyperkinet Mov (N Y). 2020 Nov 4;10:50.

 

Prudencio M, Garcia-Moreno H, Jansen-West KR, Al-Shaikh RH, Gendron TF, Heckman MG, Spiegel MR, Carlomagno Y, Daughrity LM, Song Y, Dunmore JA, Byron N, Oskarsson B, Nicholson KA, Staff NP, Gorcenco S, Puschmann A, Lemos J, Januário C, LeDoux MS, Friedman JH, Polke J, Labrum R, Shakkottai V, McLoughlin HS, Paulson HL, Konno T, Onodera O, Ikeuchi T, Tada M, Kakita A, Fryer JD, Karremo C, Gomes I, Caviness JN, Pittelkow MR, Aasly J, Pfeiffer RF, Veerappan V, Eggenberger ER, Freeman WD, Huang JF, Uitti RJ, Wierenga KJ, Marin Collazo IV, Tipton PW, van Gerpen JA, van Blitterswijk M, Bu G, Wszolek ZK, Giunti P, Petrucelli L. Toward allele-specific targeting therapy and pharmacodynamic

marker for spinocerebellar ataxia type 3. Sci Transl Med. 2020 Oct 21;12(566).

 

Shaikh AG, Beylergil SB, Scorr L, Kilic-Berkmen G, Freeman A, Klein C, Junker J, Loens S, Brüggemann N, Münchau A, Bäumer T, Vidailhet M, Roze E, Bonnet C, Jankovic J, Jimenez-Shahed J, Patel N, Marsh L, Comella C, Barbano RL, Berman BD, Malaty I, Wagle Shukla A, Reich SG, LeDoux MS, Berardelli A, Ferrazzano G, Stover N, Ondo W, Pirio Richardson S, Saunders-Pullman R, Mari Z, Agarwal P, Adler C, Chouinard S, Fox SH, Brashear A, Truong D, Suchowersky O, Frank S, Factor S, Perlmutter J, Jinnah HA. Dystonia and Tremor: A Cross-Sectional Study of the Dystonia Coalition Cohort. Neurology. 2021 Jan 26;96(4):e563-e574.

 

Calame DJ, Xiao J, Khan MM, Hollingsworth TJ, Xue Y, Person AL, LeDoux MS. Presynaptic PRRT2 Deficiency Causes Cerebellar Dysfunction and Paroxysmal Kinesigenic Dyskinesia. Neuroscience. 2020 Nov 10;448:272-286.

 

Norris SA, Jinnah HA, Klein C, Jankovic J, Berman BD, Roze E, Mahajan A, Espay AJ, Murthy AV, Fung VSC, LeDoux MS, Chang FCF, Vidailhet M, Testa C, Barbano R, Malaty IA, Bäumer T, Loens S, Wright LJ, Perlmutter JS. Clinical and Demographic Characteristics of Upper Limb Dystonia. Mov Disord. 2020 Nov;35(11):2086-2090.

 

Varga MG, Nand NP, LeDoux MS. Delayed Diagnoses of SGCE Myoclonus- Dystonia. Tremor Other Hyperkinet Mov (N Y). 2020 Jul 28;10:23.

 

Claassen DO, Corey-Bloom J, Dorsey ER, Edmondson M, Kostyk SK, LeDoux MS, Reilmann R, Rosas HD, Walker F, Wheelock V, Svrzikapa N, Longo KA, Goyal J, Hung S, Panzara MA. Genotyping single nucleotide polymorphisms for allele-selective therapy in Huntington disease. Neurol Genet. 2020 May 14;6(3):e430.

 

Miocinovic S, Vengoechea J, LeDoux MS, Isbaine F, Jinnah HA. Combined occurrence of deleterious TOR1A and ANO3 variants in isolated generalized dystonia. Parkinsonism Relat Disord. 2020 Apr;73:55-56.

 

Narayana S, Parsons MB, Zhang W, Franklin C, Schiller K, Choudhri AF, Fox PT, LeDoux MS, Cannito M. Mapping typical and hypokinetic dysarthric speech production network using a connected speech paradigm in functional MRI. Neuroimage Clin. 2020;27:102285.

 

Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323.

 

Junker J, Brandt V, Berman BD, Vidailhet M, Roze E, Weissbach A, Comella C, Malaty IA, Jankovic J, LeDoux MS, Berardelli A, Barbano R, Reich SG, Perlmutter JS, Jinnah HA, Brüggemann N. Predictors of alcohol responsiveness in dystonia. Neurology. 2018 Nov 20;91(21):e2020-e2026.

 

Tian J, Vemula SR, Xiao J, Valente EM, Defazio G, Petrucci S, Gigante AF, Rudzińska-Bar M, Wszolek ZK, Kennelly KD, Uitti RJ, van Gerpen JA, Hedera P, Trimble EJ, LeDoux MS. Whole-exome sequencing for variant discovery in blepharospasm. Mol Genet Genomic Med. 2018 May 16;6(4):601–26.