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GGF2-1101-1: Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure

Sponsor
Acorda Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01258387
Collaborator
(none)
40
Enrollment
2
Locations
1
Arm
27
Duration (Months)
20
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.

Condition or Disease Intervention/Treatment Phase
  • Drug: Glial growth factor 2/ Neuregulin 1β3
  • Other: Placebo
 Phase 1

Detailed Description

Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Double-Blind, Placebo-Controlled Study of Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: GGF2

Seven dosing cohorts: 2 patients randomized to receive 1 GGF2, 1 placebo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed

Drug: Glial growth factor 2/ Neuregulin 1β3
Other Names:
  • Recombinant Human Glial Growth Factor 2

    • Other: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) [6 months]

      Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.

    Secondary Outcome Measures

    1. Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) [Screening, day 8, day 14, day 28, and 3 months post-dose]

      An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹ Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.² ¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/ ²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286

    2. Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) [Screening, day 8, day 14, day 28, and 3 months post-dose]

      EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume

    3. Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) [Screening, day 8, day 14, day 28, and 3 months post-dose]

      ESV is the volume of blood remaining in each ventricle at the end of systole.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Left ventricular ejection fraction (LVEF) between 10% and 40%.

    2. Male or female, aged 18 to 75 years, inclusive.

    Exclusion Criteria:

    1. Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30 days prior to the screening visit.

    2. Use of any new prescription medication up to 14 days prior to receiving investigational drug.

    3. Patients with known specific hepatic disease; bilirubin >2 mg/dL, SGOT > 100 IU.

    4. Patients with a history of hepatic impairment (hepatitis B and C).

    5. Serum creatinine >2.5 mg/dL.

    6. Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Medical Group of Saint Joseph's Atlanta Georgia United States 30342
    2 Vanderbilt University Nashville Tennessee United States 37232-8802

    Sponsors and Collaborators

    • Acorda Therapeutics

    Investigators

    • Study Director: Anthony Caggiano, MD, PhD, Acorda Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Acorda Therapeutics
    ClinicalTrials.gov Identifier:
    NCT01258387
    Other Study ID Numbers:
    • 1101.1
    First Posted:
    Dec 13, 2010
    Last Update Posted:
    Jul 1, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Heart Failure
    Ventricular Dysfunction
    Ventricular Dysfunction, Left
    Mitogens

    Study Results

    Participant Flow

    Recruitment Details After informed consent, 40 patients with symptomatic Heart Failure (HF) were randomized (4:2) to GGF2 or placebo in 7 ascending dose cohorts. Patients were observed in hospital for 30 hours, then evaluated for adverse effects at 1, 2, 4, 12, and 24 weeks after infusion.
    Pre-assignment Detail There were six patients in each cohort/dose level, four received active treatment (GGF2) and two received placebo. In each dose level, the first two patients were randomized 1:1 to GGF2 or placebo and monitored for safety prior to randomizing the remaining patients in the cohort 3:1. GGF2 or placebo was administered as an IV infusion.
    Arm/Group Title GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Arm/Group Description First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed . Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
    Period Title: Overall Study
    STARTED 6 6 6 6 6 6 4
    Patients Randomized to GGF2 4 4 4 4 4 4 3
    Patients Randomized to Placebo 2 2 2 2 2 2 1
    COMPLETED 6 6 6 6 6 6 4
    NOT COMPLETED 0 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose Total
    Arm/Group Description Patients in each of 7 cohorts randomized to Placebo First dosing: patients in cohort randomized to GGF2 Second dosing: patients in cohort randomized to GGF2 Third dosing: patients in cohort randomized to GGF2 Fourth dosing: patients in cohort randomized to GGF2 Fifth dosing: patients in cohort randomized to GGF2 Sixth dosing: patients in cohort randomized to GGF2. Seventh dosing: patients in cohort randomized to GGF2 Total of all reporting groups
    Overall Participants 13 4 4 4 4 4 4 3 40
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.7
    (13.21)
    52.0
    (5.72)
    58.5
    (7.59)
    56.8
    (10.05)
    65.3
    (5.85)
    58.5
    (8.85)
    59.0
    (4.97)
    61.0
    (9.17)
    57.4
    (9.83)
    Sex: Female, Male (Count of Participants)
    Female
    1
    7.7%
    2
    50%
    0
    0%
    2
    50%
    1
    25%
    1
    25%
    0
    0%
    0
    0%
    7
    17.5%
    Male
    12
    92.3%
    2
    50%
    4
    100%
    2
    50%
    3
    75%
    3
    75%
    4
    100%
    3
    100%
    33
    82.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    13
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    3
    100%
    40
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
    Description Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Safety population
    Arm/Group Title Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Arm/Group Description
    Measure Participants 13 4 4 4 4 4 4 3
    Having Any TEAEs - Yes
    6
    46.2%
    4
    100%
    4
    100%
    2
    50%
    4
    100%
    4
    100%
    4
    100%
    3
    100%
    Having Any TEAEs - No
    7
    53.8%
    0
    0%
    0
    0%
    2
    50%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Having TEAEs Maximum Severity Mild
    5
    38.5%
    1
    25%
    3
    75%
    0
    0%
    1
    25%
    1
    25%
    2
    50%
    0
    0%
    Having TEAEs Maximum Severity Moderate
    1
    7.7%
    3
    75%
    1
    25%
    2
    50%
    2
    50%
    1
    25%
    2
    50%
    2
    66.7%
    Having TEAEs Maximum Severity Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    2
    50%
    0
    0%
    1
    33.3%
    Having TEAEs Maximum Toxicity Grade Mild
    5
    38.5%
    1
    25%
    3
    75%
    0
    0%
    1
    25%
    1
    25%
    2
    50%
    1
    33.3%
    Having TEAEs Maximum Toxicity Grade Moderate
    0
    0%
    3
    75%
    1
    25%
    2
    50%
    2
    50%
    1
    25%
    2
    50%
    1
    33.3%
    Having TEAEs Maximum Toxicity Grade Severe
    1
    7.7%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    2
    50%
    0
    0%
    1
    33.3%
    TEAEs Maximum Toxicity Grade Life-Threatening
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Having TEAEs Maximum Toxicity Grade Death
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Relationship to Study Drug -Not Related
    5
    38.5%
    1
    25%
    1
    25%
    1
    25%
    3
    75%
    1
    25%
    1
    25%
    0
    0%
    Relationship to Study Drug -Related
    1
    7.7%
    3
    75%
    3
    75%
    1
    25%
    1
    25%
    3
    75%
    3
    75%
    3
    100%
    Withdrew Due to TEAEs - Yes
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Withdrew Due to TEAEs - NO
    13
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    4
    100%
    3
    100%
    2. Secondary Outcome
    Title Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
    Description An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹ Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.² ¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/ ²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286
    Time Frame Screening, day 8, day 14, day 28, and 3 months post-dose

    Outcome Measure Data

    Analysis Population Description
    Safety Population
    Arm/Group Title Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Arm/Group Description
    Measure Participants 13 4 4 4 4 4 4 3
    Day 8
    -0.82
    (6.582)
    4.75
    (8.180)
    5.00
    (7.528)
    2.50
    (5.196)
    4.25
    (4.272)
    -1.25
    (4.992)
    5.33
    (8.083)
    4.33
    (3.055)
    Day 14
    -1.12
    (7.880)
    -5.00
    (7.257)
    5.00
    (10.863)
    2.00
    (4.546)
    4.23
    (8.328)
    2.13
    (5.360)
    11.55
    (10.007)
    7.10
    (8.627)
    Day 28
    -0.27
    (8.584)
    -2.00
    (9.345)
    8.50
    (10.472)
    4.00
    (2.449)
    8.00
    (2.000)
    5.75
    (2.500)
    12.00
    (5.099)
    10.00
    (7.550)
    3 Months
    1.88
    (8.588)
    -3.75
    (6.397)
    0.78
    (8.418)
    0.75
    (4.031)
    7.25
    (8.770)
    4.50
    (7.724)
    9.00
    (5.598)
    15.00
    (13.000)
    3. Secondary Outcome
    Title Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
    Description EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
    Time Frame Screening, day 8, day 14, day 28, and 3 months post-dose

    Outcome Measure Data

    Analysis Population Description
    Safety Population
    Arm/Group Title Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Arm/Group Description
    Measure Participants 13 4 4 4 4 4 4 3
    Day 8
    -14.89
    (74.125)
    27.50
    (27.538)
    1.98
    (29.028)
    -10.60
    (59.288)
    -2.15
    (11.098)
    -35.00
    (36.341)
    17.00
    (23.763)
    7.33
    (5.859)
    Day 14
    -41.59
    (55.252)
    31.95
    (9.450)
    -10.25
    (56.119)
    -32.83
    (44.543)
    -22.25
    (30.609)
    -26.50
    (33.071)
    -23.50
    (61.474)
    17.85
    (19.587)
    Day 28
    -25.85
    (63.405)
    13.60
    (21.750)
    49.18
    (52.333)
    -21.05
    (41.282)
    10.50
    (54.482)
    -15.80
    (20.785)
    -15.25
    (74.384)
    -3.30
    (13.262)
    3 Months
    -25.72
    (109.056)
    2.85
    (43.507)
    -8.00
    (46.168)
    48.78
    (66.896)
    -20.00
    (36.615)
    -39.85
    (52.616)
    -12.98
    (116.297)
    4.07
    (30.624)
    4. Secondary Outcome
    Title Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
    Description ESV is the volume of blood remaining in each ventricle at the end of systole.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
    Time Frame Screening, day 8, day 14, day 28, and 3 months post-dose

    Outcome Measure Data

    Analysis Population Description
    Safety Population
    Arm/Group Title Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Arm/Group Description
    Measure Participants 13 4 4 4 4 4 4 3
    Day 8
    -0.92
    (79.285)
    12.38
    (31.669)
    -6.98
    (29.443)
    -15.95
    (44.215)
    -5.25
    (15.392)
    -26.50
    (30.490)
    -9.00
    (29.017)
    -3.23
    (12.894)
    Day 14
    -19.08
    (76.181)
    33.20
    (14.200)
    -14.40
    (30.961)
    -27.65
    (31.115)
    -15.00
    (20.314)
    -27.25
    (39.339)
    -31.75
    (58.750)
    4.10
    (2.970)
    Day 28
    -3.48
    (92.552)
    10.88
    (22.885)
    22.05
    (41.977)
    -23.45
    (30.330)
    -8.88
    (25.873)
    -24.75
    (26.725)
    -28.75
    (60.808)
    -16.30
    (8.311)
    3 Months
    -12.65
    (128.433)
    6.30
    (32.395)
    -0.45
    (32.211)
    27.80
    (43.414)
    -21.25
    (23.782)
    -39.08
    (48.393)
    -18.58
    (87.663)
    -10.73
    (36.960)

    Adverse Events

    Time Frame 6 months
    Adverse Event Reporting Description Serious Treatment Emergent Adverse Events (TEAE) are defined as serious Adverse Events (AE) with date of onset (or worsening) on or after the start date of double-blind treatment.
    Arm/Group Title Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Arm/Group Description First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed . Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
    All Cause Mortality
    Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/13 (0%) 1/4 (25%) 1/4 (25%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Cardiac disorders
    Angina pectoris 0/13 (0%) 0 0/4 (0%) 0 1/4 (25%) 1 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/3 (0%) 0
    Cardiac failure congestive 0/13 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 1/4 (25%) 1 0/4 (0%) 0 0/4 (0%) 0 0/3 (0%) 0
    Hepatobiliary disorders
    Hy's law case 0/13 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 1/3 (33.3%) 1
    Infections and infestations
    Viral infection 0/13 (0%) 0 1/4 (25%) 1 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/3 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo GGF2 First Dose GGF2 Second Escalated Dose GGF2 Third Escalated Dose GGF2 Fourth Escalated Dose GGF2 Fifth Escalated Dose GGF2 Sixth Escalated Dose GGF2 Seventh Escalataed Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/13 (46.2%) 4/4 (100%) 4/4 (100%) 2/4 (50%) 4/4 (100%) 4/4 (100%) 4/4 (100%) 3/3 (100%)
    Cardiac disorders
    Angina pectoris 0/13 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Cardiac failure congestive 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Cardiac flutter 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Ear and labyrinth disorders
    Ear pain 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Eye disorders
    Vitreous floaters 0/13 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Gastrointestinal disorders
    Nausea 2/13 (15.4%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 1/4 (25%) 2/4 (50%) 1/4 (25%) 2/3 (66.7%)
    Diarrhoea 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 1/4 (25%) 2/3 (66.7%)
    Abdominal distension 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 2/3 (66.7%)
    Abdominal Pain 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Abdominal tenderness 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Gastritis 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/3 (0%)
    Haemorrhoids 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Toothache 1/13 (7.7%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Vomiting 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    General disorders
    Fatigue 1/13 (7.7%) 1/4 (25%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 2/4 (50%) 2/4 (50%) 0/3 (0%)
    Feeling hot 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Infusion site pain 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Injection site haematoma 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Injection site scab 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Pain 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/3 (0%)
    Pyrexia 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Influenza like illness 1/13 (7.7%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Hepatobiliary disorders
    Hy's law case 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Infections and infestations
    Upper respiratory tract infection 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Bronchitis 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Viral infection 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Injury, poisoning and procedural complications
    Infusion related reaction 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/3 (0%)
    Muscle strain 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Investigations
    Gamma-glutamyltransferase increased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 3/3 (100%)
    Brain natriuretic peptide increased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 1/4 (25%) 0/3 (0%)
    Blood bilirubin increased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Blood chloride increased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Blood creatinine increased 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Blood potassium increased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Glomerular filtration rate decreased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Heart rate increased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Weight decreased 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 1/3 (33.3%)
    Fluid retention 1/13 (7.7%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Gout 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/3 (0%)
    Hyperuricaemia 1/13 (7.7%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Hypokalaemia 1/13 (7.7%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Muscle spasms 0/13 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Myalgia 0/13 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Neck pain 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Pain in jaw 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Tendonitis 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Nervous system disorders
    Headache 0/13 (0%) 0 2/4 (50%) 0 2/4 (50%) 0 1/4 (25%) 0 0/4 (0%) 0 2/4 (50%) 0 2/4 (50%) 0 1/3 (33.3%) 0
    Dysgeusia 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 2/4 (50%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Dizziness 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Lethargy 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Sinus headache 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Renal and urinary disorders
    Chromaturia 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/3 (33.3%)
    Nephrolithiasis 0/13 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 2/4 (50%) 0/4 (0%) 0/3 (0%)
    Dyspnoea 0/13 (0%) 2/4 (50%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/3 (0%)
    Nasal conjestion 0/13 (0%) 2/4 (50%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Sinus congestion 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Upper-airway cough syndrome 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Wheezing 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/3 (0%)
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Skin discolouration 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Vascular disorders
    Hypotension 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 1/4 (25%) 1/3 (33.3%)
    Flushing 0/13 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/3 (0%)
    Hot flush 0/13 (0%) 0/4 (0%) 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%)
    Vein pain 0/13 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) 1/4 (25%) 0/3 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor (Acorda) has the right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.

    Results Point of Contact

    Name/Title Anthony Caggiano, MD, PhD
    Organization Acorda Therapeutics, Inc.
    Phone 914-347-4300 ext 5150
    Email tcaggiano@acorda.com
    Responsible Party:
    Acorda Therapeutics
    ClinicalTrials.gov Identifier:
    NCT01258387
    Other Study ID Numbers:
    • 1101.1
    First Posted:
    Dec 13, 2010
    Last Update Posted:
    Jul 1, 2014
    Last Verified:
    Jun 1, 2014