A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

PHASE2TerminatedINTERVENTIONAL
Enrollment

378

Participants

Timeline

Start Date

December 12, 2016

Primary Completion Date

November 20, 2019

Study Completion Date

November 20, 2019

Conditions
Progressive Supranuclear Palsy
Interventions
DRUG

Placebo

Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW \>59 kg, 4.7 mL/min or 282 mL/hr.

DRUG

ABBV-8E12

Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW \>59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.

Trial Locations (66)

2145

Westmead Hospital /ID# 154403, Westmead

3004

Alfred Hospital /ID# 153158, Melbourne

4006

Q-Pharm Pty Limited /ID# 154410, Herston

5000

Royal Adelaide Hospital /ID# 153157, Adelaide

6005

Neurodegenerative Disorders Re /ID# 153770, West Perth

13385

Hopital de la Timone /ID# 153113, Marseille

20089

IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092, Rozzano

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982, Milan

28007

Hospital General Universitario Gregorio Maranon /ID# 200876, Madrid

30126

IRCCS Ospedale San Camillo /ID# 153101, Venezia LIDO

30912

Georgia Regents University /ID# 144908, Augusta

31059

Hopital Universitaire Purpan /ID# 153152, Toulouse

32224

Mayo Clinic /ID# 144911, Jacksonville

32610

University of Florida - Archer /ID# 144906, Gainesville

33076

Chu de Bordeaux Hopital /Id# 153151, Bordeaux

33612

University of South Florida /ID# 144912, Tampa

35233

University of Alabama at Birmingham - Main /ID# 144892, Birmingham

40536

University of Kentucky Chandler Medical Center /ID# 144891, Lexington

41001

Hosp Univ Virgen del Rocio /ID# 201039, Seville

44195

Cleveland Clinic Main Campus /ID# 144885, Cleveland

44791

St. Josef-Hospital /ID# 201984, Bochum

46202

Indiana University /ID# 149036, Indianapolis

59037

Hopital B Roger Salengro /ID# 153943, Lille

60612

Rush University Medical Center /ID# 144894, Chicago

64111

St. Luke's Hosp. of Kansas Cit /ID# 168629, Kansas City

67200

CHU Strasbourg Hautepierre Hos /ID# 206942, Strasbourg

75651

Hopital Pitie Salpetriere /ID# 153942, Paris

77054

McGovern Medical School /ID# 149236, Houston

78681

Central Texas Neurology Consul /ID# 167417, Round Rock

80802

TU Uniklinik Munchen /ID# 153154, Munich

83734

KH Agatharied /ID# 154166, Hausham

85259

Mayo Clinic - Scottsdale /ID# 144893, Scottsdale

86077

Istituto Neuro Mediterraneo IR /ID# 153106, Pozzilli

88100

Universita di Catanzaro Magna Graecia /ID# 166322, Catanzaro

89081

Universitaetsklinikum Ulm /ID# 153155, Ulm

89106

Cleveland Clinic Lou Ruvo Cent /ID# 148919, Las Vegas

90033

Usc /Id# 149773, Los Angeles

90095

University of California, Los Angeles /ID# 144896, Los Angeles

90211

Cedars-Sinai Medical Center /ID# 149775, Beverly Hills

92093

Ucsd /Id# 144905, La Jolla

97239

Oregon Health and Science University /ID# 149774, Portland

4658620

National Hospital Organization Higashinagoya National Hospital /ID# 201514, Nagoya

94143-2204

Univ California, San Francisco /ID# 144897, San Francisco

80113-2736

Rocky Mountain Movement Disorders Center /ID# 153397, Englewood

60637-1443

University of Chicago /ID# 148672, Chicago

55905-0001

Mayo Clinic - Rochester /ID# 144895, Rochester

08901

Rutgers Robert Wood Johnson /ID# 144901, New Brunswick

10032-3725

COLUMBIA University Medical Center /ID# 149037, New York

37232-0011

Vanderbilt Univ Med Ctr /ID# 144898, Nashville

75231-4316

Kerwin Research Center /ID# 144904, Dallas

T2N 4Z6

University of Calgary /ID# 154393, Calgary

V1Y 1Z9

OCT Research ULC /ID# 169688, Kelowna

M5T 2S8

Toronto Western Hospital /ID# 152818, Toronto

H2X 0A9

Crchum /Id# 152819, Montreal

H3A 2B4

Montreal Neurological Institut /ID# 156413, Montreal

04103

Universitaetsklinikum Leipzig /ID# 201761, Leipzig

00168

Policlinico Agostino Gemelli /ID# 153104, Rome

05100

A.O. Santa Maria /ID# 153102, Terni

070-8644

National Hospital Organization Asahikawa Medical Center /ID# 201585, Asahikawa

616-8255

National Hospital Organization Utano National Hospital /ID# 201979, Kyoto

980-8574

Tohoku University Hospital /ID# 202307, Sendai

982-8555

NHO Sendai Nishitaga National Hospital /ID# 202132, Sendai

951-8520

Niigata University Medical & Dental Hospital /ID# 201680, Niigata

565-0871

Osaka University Hospital /ID# 201980, Suita-shi

113-8431

Juntendo University Hospital /ID# 200870, Bunkyo-ku

187-8551

National Center of Neurology and Psychiatry /ID# 202037, Kodaira

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY