Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS) (ASPEN-OLS)


P2B001 is a twelve-week, randomized, double-blind, double-dummy, 4-arm, parallel group, multi-center, multinational study to determine the efficacy, safety and tolerability of P2B001 in subjects with early PD as compared to its individual components and compared to a calibration arm of pramipexole ER.  A total of 525 early stage untreated PD patients will be randomized to 4-arms of treatment with: P2B001, a once daily (pramipexole 0.6mg / rasagiline 0.75 mg), or to pramipexole 0.6 mg once daily, or to rasagiline 0.75 mg once daily, or to pramipexole ER titrated to optimal dose (1.5, 3.0 or 4.5mg) using a randomization scheme of 2:2:2:1, respectively. Subjects will be recruited from approximately 70 sites in North America and Europe.

The Dystonia Coalition is a collaboration of medical researchers and patient advocacy groups that is working to advance the pace of clinical and translational research in the dystonias to find better treatments and a cure.

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Recent Publications

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 (2020) Clinical and demographic characteristics of upper limb dystonia. Mov Disord Aug 26.  doi: 10.1002/mds.28223.

Varga MG, Nand NP, LeDoux MS (2020) Delayed diagnoses of SGCE myoclonus-dystonia. Tremor Other Hyperkinet Mov (N Y) 10:23.


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


Miocinovic S, Vengoechea J, LeDoux MS, Jinnah HA (2020) Combined occurrence of deleterious TOR1A and ANO3 variants in isolated generalized dystonia. Parkinsonism and Related Disorders 73:55-56.


Claassen DO, Corey-Bloom J, Dorsey ER, Edmondson M, Kostyk S, LeDoux MS, Reilmann R, Rosas HD, Walker F, Wheelock V, Svrzikapa N, Longo KA, Goyal J, Hung S, Panzara M (2020) Frequency of Single Nucleotide Polymorphisms (SNPs) rs362307 or rs362331 in Patients with Huntington’s Disease (HD): Results from a prospective observational research study. Neurology Genetics 6:3.


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. 


Vollstedt EJ, Kasten M, Klein C; MJFF Global Genetic Parkinson's Disease Study Group. Using global team science to identify genetic parkinson's disease worldwide. Ann Neurol. 2019 Aug;86(2):153-157. 


Khan MM, Xiao J, Hollingsworth TJ, Patel D, Selley DE, Ring TL, LeDoux MS. Gnal haploinsufficiency causes genomic instability and increased sensitivity to haloperidol. Exp Neurol. 2019 Aug;318:61-70. 


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. 


Xiao J, Khan MM, Vemula S, Tian J, LeDoux MS. Consequences of Cre-mediated deletion of Ciz1 exon 5 in mice. FEBS Lett. 2018 Sep;592(18):3101-3110.

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.

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