Safety, tolerability, and efficacy of PBT2 in Huntington's disease: A phase 2, randomised, double-blind, placebo-controlled trial

Journal article


Angus, D., Herd, C., Stone, C., Stout, Julie, Wieler, Marguerite, Reilmann, Ralf, Ritchie, C. W., Dorsey, Earl Ray, Helles, K., Kayson, Elise, Oakes, David, Rosas, Herminia Diana, Vaughan, Carr J., Panegyres, Peter K., Ames, David J., Goh, Anita, Agarwal, Pinky, Churchyard, Andrew, Murathodizic, M., ... Targum, S.. (2015) Safety, tolerability, and efficacy of PBT2 in Huntington's disease: A phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurology. 14(1), pp. 39 - 47. https://doi.org/10.1016/S1474-4422(14)70262-5
AuthorsAngus, D., Herd, C., Stone, C., Stout, Julie, Wieler, Marguerite, Reilmann, Ralf, Ritchie, C. W., Dorsey, Earl Ray, Helles, K., Kayson, Elise, Oakes, David, Rosas, Herminia Diana, Vaughan, Carr J., Panegyres, Peter K., Ames, David J., Goh, Anita, Agarwal, Pinky, Churchyard, Andrew, Murathodizic, M., Chua, Phyllis, Germaine, D., Lim, D. L., Mack, H., Loy, Clement T. H., Griffith, Jane, Mitchell, Patrick, Corey-Bloom, Jody, Gluhm, Shea, Goldstein, Jody, Levi, L., Margolis, Russell L., Yoritomo, Nadine, Janicki, Sarah Christine, Marder, Karen, Clouse, Ronda, Singer, Carlos, Moore, Henry, Padron, N., Kostyk, Sandra, Daley, A., Sergo, Vicki, Kumar, Rajeev Ananda, Anderson, Karen E., Drazinic, Carolyn M., Hennig, B., Nance, Martha A., Molho, Eric S., Criswell, Susan R., LeDoux, Mark S., Guyot, S., Iannaccone, A., Jennings, B., Leavitt, Blair R., Feigin, Andrew S., Evans, Scott R., Wray, S., Casaceli, Cindy, Orme, Constance, Gao, S., Watts, A., Baker, K., Labuschagne, Izelle, El-Dairi, M., Fekrat, S., Hersch, S., Moscovitch-Lopatin, M., Ranzi, R. and Targum, S.
Abstract

Background: PBT2 is a metal protein-attenuating compound that might reduce metal-induced aggregation of mutant huntingtin and has prolonged survival in a mouse model of Huntington's disease. We aimed to assess the safety, tolerability, and efficacy of PBT2 in patients with Huntington's disease.

Methods: In this 26-week, randomised, double-blind, placebo-controlled trial, adults ( ≥ 25 years old ) with early-stage to mid-stage Huntington's disease were randomly assigned ( 1:1:1 ) by a centralised interactive response system to once daily PBT2 250 mg, PBT2 100 mg, or placebo. Randomisation was stratified by site with a block size of three. Participants, carers, the steering committee, site investigators, study staff, and the study sponsor were masked to treatment assignment. Primary endpoints were safety and tolerability. The safety population consisted of all participants who were randomly assigned and had at least one dose of study drug. The principal secondary endpoint was cognition, measured by the change from baseline to week 26 in the main composite Z score of five cognitive tests ( Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, and Stroop Word Reading Test ) and scores on eight individual cognitive tests ( the five aforementioned plus the Trail Making Test Part A, Montreal Cognitive Assessment, and the Speeded Tapping Test ). The intention-to-treat population comprised participants who were randomly assigned and had at least one efficacy assessment after administration of study drug. This trial is registered with [http://clinicaltrials.gov/] ClinicalTrials.gov, [http://clinicaltrials.gov/show/NCT01590888] NCT01590888.

Findings: Between April 18, 2012, and Dec 14, 2012, 109 participants were randomly assigned to PBT2 250 mg ( n=36 ), PBT2 100 mg ( n=38 ), or placebo ( n=35 ) at 19 research centres in Australia and the USA. 32 ( 89% ) individuals on PBT2 250 mg, 38 ( 100% ) on PBT2 100 mg, and 34 ( 97% ) on placebo completed the study. Six serious adverse events ( acute coronary syndrome, major depression, pneumonia, suicide attempt, viral infection, and worsening of Huntington's disease ) occurred in five participants in the PBT2 250 mg group, three ( fall with subdural haematoma, suicide attempt, and hospital admission for stabilisation of Huntington's disease ) occurred in two participants in the PBT2 100 mg group, and one ( increasing aggression ) occurred in a participant in the placebo group. The site investigators deemed all, except the worsening of Huntington's disease, as unrelated to study drug. 32 ( 89% ) participants on PBT2 250 mg, 30 ( 79% ) on PBT2 100 mg, and 28 ( 80% ) on placebo had at least one adverse event. Compared with placebo, neither PBT2 100 mg ( least-squares mean 0·02, 95% CI −0·10 to 0·14; p=0·772 ) nor PBT2 250 mg ( 0·07, −0·05 to 0·20; p=0·240 ) significantly improved the main composite cognition Zscore between baseline and 26 weeks. Compared with placebo, the Trail Making Test Part B score was improved between baseline and 26 weeks in the PBT2 250 mg group ( 17·65 s, 0·65–34·65; p=0·042 ) but not in the 100 mg group ( 0·79 s improvement, −15·75 to 17·32; p=0·925 ); neither dose significantly improved cognition on the other tests.

Interpretation: PBT2 was generally safe and well tolerated in patients with Huntington's disease. The potential benefit on executive function will need to be confirmed in a larger study.

Funding: Prana Biotechnology Limited.

Year2015
JournalLancet Neurology
Journal citation14 (1), pp. 39 - 47
PublisherLancet Publishing Group
ISSN1474-4422
Digital Object Identifier (DOI)https://doi.org/10.1016/S1474-4422(14)70262-5
Scopus EID2-s2.0-84918785958
Page range39 - 47
Research GroupSchool of Philosophy
Place of publicationUnited Kingdom
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Papoutsi, Marina, Labuschagne, Izelle, Tabrizi, Sarah J. and Stout, Julie C.. (2014) The cognitive burden in Huntington's disease: Pathology, phenotype and mechanisms of compensation. Movement Disorders Society. 29(5), pp. 673 - 683. https://doi.org/10.1002/mds.25864
A comparison of executive function in Body Dysmorphic Disorder (BDD) and Obsessive-Compulsive Disorder (OCD)
Labuschagne, Izelle, Rossell, Susan, Dunai, Judith, Castle, David and Kyrios, Michael. (2013) A comparison of executive function in Body Dysmorphic Disorder (BDD) and Obsessive-Compulsive Disorder (OCD). Journal of Obsessive-Compulsive and Related Disorders. 2(3), pp. 257 - 262. https://doi.org/10.1016/j.jocrd.2013.05.003
Oxytocin enhances resting-state connectivity between amygdala and medial frontal cortex
Sripada, Chandra, Phan, Kinhluan, Labuschagne, Izelle, Welsh, Robert, Nathan, Pradeep and Wood, Amanda. (2013) Oxytocin enhances resting-state connectivity between amygdala and medial frontal cortex. International Journal of Neuropsychopharmacology (print). 16(2), pp. 255 - 260. https://doi.org/10.1017/S1461145712000533
Emotional face recognition deficits and medication effects in pre-manifest through stage-II Huntington's disease
Labuschagne, Izelle, Jones, Rebecca, Callaghan, Jenny, Whitehead, Daisy, Dumas, Eve, Say, Miranda, Hart, Ellen, Justo, Damian, Coleman, Allison, Dar Santos, Rachelle, Frost, Chris, Craufurd, David, Trabrizi, Sarah and Stout, Julie. (2013) Emotional face recognition deficits and medication effects in pre-manifest through stage-II Huntington's disease. Psychiatry Research. 207(1-2), pp. 118 - 126. https://doi.org/10.1016/j.psychres.2012.09.022
A systematic review of pre-surgical exercise intervention studies with cancer patients
Singh, Favil, Newton, U, Galvao, Daniel, Spry, Nigel and Baker, Michael. (2013) A systematic review of pre-surgical exercise intervention studies with cancer patients. Surgical Oncology. https://doi.org/10.1016/j.suronc.2013.01.004
Long-term effects of intermittent androgren suppression therapy on lean and fat mass : a 33 month prospective study
Spry, Nigel, Taaffe, D R., England, P J., Judge, J S., Stephens, D A., Peddle-McIntyre, C, Baker, Michael, Newton, R and Galvao, Daniel. (2013) Long-term effects of intermittent androgren suppression therapy on lean and fat mass : a 33 month prospective study. Prostate Cancer and Prostatic Diseases. https://doi.org/10.1038/pcan.2012.33
Emotional face recognition deficits and medication effects in pre-manifest through stage-II Huntington's disease
Labuschagne, Izelle, Jones, Rebecca, Callaghan, Jenny, Whitehead, Daisy, Dumas, Eve, Say, Miranda, Hart, Ellen, Justo, Damian, Coleman, Allison, Dar Santos, Rachelle, Frost, Chris, Craufurd, David, Tabrizi, Sarah and Stout, Julie. (2013) Emotional face recognition deficits and medication effects in pre-manifest through stage-II Huntington's disease. Psychiatry Research. 207(1-2), pp. 118 - 126. https://doi.org/10.1016/j.psychres.2012.09.022
Changes in insulin resistance and HbA1c are related to exercise-mediated changes in body composition in older adults with Type 2 Diabetes : Interim outcomes from the GREAT2DO trial
Mavros, Yorgi, Kay, Shelley, Anderberg, Kylie, Baker, Michael K., Wang, Yi, Zhao, Renru, Meiklejohn, Jacinda, Climstein, Mike, O'Sullivan, Anthony and De Vos, Nathan. (2013) Changes in insulin resistance and HbA1c are related to exercise-mediated changes in body composition in older adults with Type 2 Diabetes : Interim outcomes from the GREAT2DO trial. Diabetes Care. 36(8), pp. 2372 - 2379. https://doi.org/10.2337/dc12-2196
Oxytocin enhances resting-state connectivity between amygdala and medial frontal cortex
Sripada, Chandra, Phan, Kinhluan, Labuschagne, Izelle, Welsh, Robert, Nathan, Pradeep and Wood, Amanda. (2013) Oxytocin enhances resting-state connectivity between amygdala and medial frontal cortex. International Journal of Neuropsychopharmacology. 16(2), pp. 255 - 260. https://doi.org/10.1017/S1461145712000533
Visual working memory impairment in premanifest gene-carriers and early Huntington's Disease
Dumas, Eve M., Say, Miranda Julia, Jones, Rebecca D., Labuschagne, Izelle, O'Regan, Alison M., Hart, Ellen P., van den Bogaard, Simon J. A., Queller, Sarah, Justo, Damian, Coleman, Allison J., dar Santos, Rachelle C., Durr, Alexandra, Leavitt, Blair R., Tabrizi, Sarah J., Roos, Raymund A. C. and Stout, Julie C.. (2012) Visual working memory impairment in premanifest gene-carriers and early Huntington's Disease. Journal of Huntington's Disease. 1(1), pp. 97 - 106. https://doi.org/10.3233/JHD-2012-120010
Evaluation of longitudinal 12 and 24 month cognitive outcomes in premanifest and early Huntington's disease
Stout, Julie, Jones, Rebecca, Labuschagne, Izelle, O'Regan, Alison, Say, Miranda, Dumas, Eve, Queller, Sarah, Justo, Damian, Dar Santos, Rachelle, Coleman, Allison, Hart, Ellen, Durr, Alexandra, Leavitt, Blair, Roos, Raymund, Langbehn, Doug, Tabrizi, Sarah J. and Frost, Chris. (2012) Evaluation of longitudinal 12 and 24 month cognitive outcomes in premanifest and early Huntington's disease. Journal of Neurology, Neurosurgery and Psychiatry. 83(7), pp. 687 - 694. https://doi.org/10.1136/jnnp-2011-301940
Exercise prescriptions for patients with type 2 diabetes and pre-diabetes : A position statement from Exercise and Sports Science Australia
Hordern, Matthew, Dunstan, David, Prins, Johannes, Baker, Michael, Fiatarone Singh, Maria and Coombes, Jeff. (2012) Exercise prescriptions for patients with type 2 diabetes and pre-diabetes : A position statement from Exercise and Sports Science Australia. Journal of Science and Medicine in Sport. 15(1), pp. 25 - 31. https://doi.org/10.1016/j.jsams.2011.04.005
Medial frontal hyperactivity to sad faces in generalized social anxiety disorder and modulation by oxytocin
Labuschagne, Izelle, Phan, K. Luan, Wood, Amanda, Angstadt, Mike, Chua, Phyllis, Heinrichs, Markus, Stout, Julie C., Nathan, Pradeep J. and Pradeep, . (2012) Medial frontal hyperactivity to sad faces in generalized social anxiety disorder and modulation by oxytocin. International Journal of Neuropsychopharmacology (print). 15(7), pp. 883 - 896. https://doi.org/10.1017/S1461145711001489
Evaluation of longitudinal 12 and 24 month cognitive outcomes in premanifest and early Huntington's disease
Stout, Julie, Jones, Rebecca, Labuschagne, Izelle, O'Regan, Alison, Say, Miranda, Dumas, Eve, Queller, Sarah, Justo, Damian, Dar Santos, Rachelle, Coleman, Allison, Hart, Ellen, Durr, Alexandra, Leavitt, Blair, Roos, Raymund, Langbehn, Douglas, Tabrizi, Sarah J. and Frost, Chris. (2012) Evaluation of longitudinal 12 and 24 month cognitive outcomes in premanifest and early Huntington's disease. Journal of Neurology, Neurosurgery and Psychiatry. 83(7), pp. 687 - 694. https://doi.org/10.1136/jnnp-2011-301940
Study of Mental Activity and Regular Training (SMART) in at risk individuals: A randomised double blind, sham controlled, longitudinal trial
Gates, Nicola, Valenzuela, Michael, Sachdev, Peminder, Singh, Nalin, Baune, Bernhard, Brodaty, Henry, Suo, Chao, Jain, Nidhi, Wilson, Guy, Wang, Yi, Baker, Michael, Williamson, Dominique, Foroughi, Nasim and Fiatarone Singh, Maria Antoinette. (2011) Study of Mental Activity and Regular Training (SMART) in at risk individuals: A randomised double blind, sham controlled, longitudinal trial. BMC Geriatrics. 11(19), pp. 19 - 33. https://doi.org/10.1186/1471-2318-11-19
Behavioral strategies in diabetes prevention programs :A systematic review of randomized controlled trials
Baker, Michael, Simpson, Kylie, Lloyd, Bradley, Bauman, Adrian and Fiatarone Singh, Maria. (2011) Behavioral strategies in diabetes prevention programs :A systematic review of randomized controlled trials. Diabetes Research and Clinical Practice. 91(1), pp. 1 - 12. https://doi.org/10.1016/j.diabres.2010.06.030
Lower limb muscle strengthening does not change frontal plane moments in women with knee osteoarthritis :A randomized controlled trial
Foroughi, Nasim, Smith, Richard, Lange, Angela, Baker, Michael, Fiatarone Singh, Maria and Vanwanseele, Benedicte. (2011) Lower limb muscle strengthening does not change frontal plane moments in women with knee osteoarthritis :A randomized controlled trial. Clinical Biomechanics. 26(2), pp. 167 - 174. https://doi.org/10.1016/j.clinbiomech.2010.08.011
Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC) :a cluster randomised controlled trial
Middleton, Sandy, McElduff, P., Ward, J., Grimshaw, J., Dale, S., D'Este, C., Drury, P., Griffiths, R., Cheung, N., Quinn, C., Evans, M., Cadilhac, D. and Levi, C.. (2011) Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC) :a cluster randomised controlled trial. The Lancet. 378(9804). https://doi.org/10.1016/S0140-6736(11)61485-2
A randomized controlled trial of whole body vibration exposure on markers of bone turnover in postmenopausal women
Turner, Sarah, Torode, Margaret Ellen, Climstein, Michael, Naughton, Geraldine, Greene, David, Baker, Michael and Fiatarone Singh, Maria. (2011) A randomized controlled trial of whole body vibration exposure on markers of bone turnover in postmenopausal women. Journal of Osteoporosis. 2011(1), pp. 1 - 10. https://doi.org/10.4061/2011/710387
Core self-evaluation as a predictor of strength training adoption in older adults
Baker, Michael, Kennedy, David, Bohle, Philip, Campbell, Deena, Wiltshire, James and Fiatarone Singh, Maria Antoinette. (2011) Core self-evaluation as a predictor of strength training adoption in older adults. Maturitas. 68(1), pp. 88 - 93. https://doi.org/10.1016/j.maturitas.2010.10.001
Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial
Galvao, Daniel, Taaffe, D R, Cormie, P, Spry, Nigel, Chambers, Suzanne, Peddle-McIntyre, C, Baker, Michael, Denham, James, Joseph, David and Groom, Geoff. (2011) Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. BMC Cancer. 11(13), pp. 517 - 523. https://doi.org/10.1186/1471-2407-11-517
A systematic review and meta-analysis on the effect of aerobic vs. resistance exercise training on visceral fat
Ismail, I, Keating, S, Baker, Michael and Johnson, Nathan. (2011) A systematic review and meta-analysis on the effect of aerobic vs. resistance exercise training on visceral fat. Obesity Reviews. 13(1), pp. 68 - 91. https://doi.org/10.1111/j.1467-789X.2011.00931.x
Death, dependency and health status 90 days following hospital admission for acute stroke in NSW
Middleton, Sandy, Levi, C., Ward, J., Grimshaw, J., Griffiths, R., D'Este, C., Dale, S., Quinn, C., Evans, M., Cadilhac, D. and McElduff, P.. (2011) Death, dependency and health status 90 days following hospital admission for acute stroke in NSW. Internal Medicine Journal. 41(10), pp. 736 - 743. https://doi.org/10.1111/j.1445-5994.2010.02330.x
What the cognitive deficits in body dysmorphic disorder tell us about the underlying neurobiology: An investigation of three cases
Labuschagne, Izelle, Castle, David and Rossell, Susan L.. (2011) What the cognitive deficits in body dysmorphic disorder tell us about the underlying neurobiology: An investigation of three cases. International Journal of Cognitive Therapy. 4(1), pp. 21 - 33. https://doi.org/10.1521/ijct.2011.4.1.21
Oxytocin attenuates amygdala reactivity to fear in generalized social anxiety disorder
Labuschagne, Izelle, Phan, K. Luan, Wood, Amanda G., Angstadt, Mike, Chua, Phyllis, Heinrichs, Markus, Stout, Julie C. and Nathan, Pradeep. (2010) Oxytocin attenuates amygdala reactivity to fear in generalized social anxiety disorder. Neuropsychopharmacology. 35(12), pp. 2403 - 2413. https://doi.org/10.1038/npp.2010.123
The relationship between knee adduction moment and cartilage and meniscus morphology in women with osteoarthritis
Vanwanseele, Benedicte, Eckstein, Felix, Smith, Richard, Lange, Angela, Foroughi, Nasim, Baker, Michael, Shnier, Ron and Fiatarone Singh, Maria Antoinette. (2010) The relationship between knee adduction moment and cartilage and meniscus morphology in women with osteoarthritis. Osteoarthritis and Cartilage. 18(7), pp. 894 - 901. https://doi.org/10.1016/j.joca.2010.04.006
Augmenting serotonin neurotransmission with citalopram modulates emotional expression decoding but not structural encoding of moderate intensity sad facial emotional stimuli: An event-related potential (ERP) investigation
Labuschagne, Izelle, Croft, Rodney, Phan, K. Luan and Nathan, Pradeep. (2010) Augmenting serotonin neurotransmission with citalopram modulates emotional expression decoding but not structural encoding of moderate intensity sad facial emotional stimuli: An event-related potential (ERP) investigation. Journal of Psychopharmacology. 24(8), pp. 1153 - 1164. https://doi.org/10.1177/0269881108097878
Executive function in body dysmorphic disorder
Dunai, Judith, Labuschagne, Izelle, Castle, David J., Kyrios, Michael and Rossell, Susan. (2010) Executive function in body dysmorphic disorder. Psychological Medicine. 40(9), pp. 1541 - 1548. https://doi.org/10.1017/S003329170999198X
Dynamic alignment and its association with knee adduction moment in medial knee osteoarthritis
Foroughi, Nasim, Smith, Richard, Lange, Angela, Baker, Michael, Fiatarone Singh, Maria and Vanwanseele, Benedicte. (2010) Dynamic alignment and its association with knee adduction moment in medial knee osteoarthritis. The Knee. 17(3), pp. 210 - 216. https://doi.org/10.1016/j.knee.2009.09.006
An examination of delusional thinking and cognitive styles in body dysmorphic disorder
Labuschagne, Izelle, Castle, David J., Dunai, Judith, Kyrios, Michael and Rossell, Susan. (2010) An examination of delusional thinking and cognitive styles in body dysmorphic disorder. Australian and New Zealand Journal of Psychiatry. 44(8), pp. 706 - 712. https://doi.org/10.3109/00048671003671007
Resistive exercise for arthritic cartilage health (REACH): A randomized double-blind, sham-exercise controlled trial
Lange, Angela K., Vanwanseele, Benedicte, Foroughi, Nasim, Baker, Michael Kevin, Shnier, Ronald C., Smith, Richard M. and Singh, Maria Fiatarone. (2009) Resistive exercise for arthritic cartilage health (REACH): A randomized double-blind, sham-exercise controlled trial. BMC Geriatrics. 9(1), pp. 1 - 10. https://doi.org/10.1186/1471-2318-9-1
Evidence for modulation of facial emotional processing bias during emotional expression decoding by serotonergic and noradrenergic antidepressants: An event-related potential (ERP) study
Kerestes, Rebecca, Labuschagne, Izelle, Croft, Rodney, O'Neill, Barry, Bhagwagar, Zubin M., Phan, K Luan and Nathan, Pradeep. (2009) Evidence for modulation of facial emotional processing bias during emotional expression decoding by serotonergic and noradrenergic antidepressants: An event-related potential (ERP) study. Psychopharmacology. 202(4), pp. 621 - 634. https://doi.org/10.1007/s00213-008-1340-3
Obesity effects on depression: Systematic review of epidemiological studies
Atlantis, Evan and Baker, Michael Kevin. (2008) Obesity effects on depression: Systematic review of epidemiological studies. International Journal of Obesity. 32(6), pp. 881 - 891. https://doi.org/10.1038/ijo.2008.54
Multi-modal exercise programs for older adults
Baker, Michael, Atlantis, Evan and Fiatarone Singh, Maria. (2007) Multi-modal exercise programs for older adults. Age and Ageing. 36, pp. 375 - 381. https://doi.org/10.1093/ageing/afm054
Efficacy and feasibility of a novel tri-modal robust exercise prescription in a retirement community : A randomized, controlled trial
Baker, Michael, Kennedy, David, Bohle, Philip, Campbell, Deena, Knapman, Leona, Grady, Jodie, Wiltshire, James, McNamara, Maria, Evans, William and Fiatarone Singh, Maria. (2007) Efficacy and feasibility of a novel tri-modal robust exercise prescription in a retirement community : A randomized, controlled trial. Journal of the American Geriatrics Society. 55, pp. 1 - 10. https://doi.org/10.1111/j.1532-5415.2006.01031.x
Degenerative meniscus tears and mobility impairment in women with knee osteoarthritis
Lange, Angela, Fiatarone Singh, Maria, Smith, Richard, Foroughi, Nasim, Baker, Michael, Shnier, Ron and Vanwanseele, Benedicte. (2007) Degenerative meniscus tears and mobility impairment in women with knee osteoarthritis. Osteoarthritis and Cartilage. 15(6), pp. 701 - 708. https://doi.org/10.1016/j.joca.2006.11.004