Trial Outcomes & Findings for Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease. (NCT NCT03051607)
NCT ID: NCT03051607
Last Updated: 2019-05-03
Results Overview
The primary objective of this study was to evaluate the safety and tolerability of tozadenant in levodopa-treated Parkinson's Disease (PD) patients experiencing motor fluctuations, based on assessment of treatment-emergent adverse events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory tests. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
Up to 28 Weeks including safety follow-up visit.
Results posted on
2019-05-03
Participant Flow
The disposition of study patients. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS) as well as the Full Analysis Set (FAS).
Participant milestones
| Measure |
Tozadenant
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
66
|
Reasons for withdrawal
| Measure |
Tozadenant
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
Overall Study
Adverse Event
|
66
|
Baseline Characteristics
Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.
Baseline characteristics by cohort
| Measure |
Tozadenant
n=66 Participants
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 8.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=5 Participants
|
|
Weight at Screening
|
80.4 kg
STANDARD_DEVIATION 17.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 Weeks including safety follow-up visit.Population: Safety evaluation was based on Safety Set which included all 66 patients enrolled in the study.
The primary objective of this study was to evaluate the safety and tolerability of tozadenant in levodopa-treated Parkinson's Disease (PD) patients experiencing motor fluctuations, based on assessment of treatment-emergent adverse events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory tests. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS).
Outcome measures
| Measure |
Tozadenant
n=66 Participants
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
Subjects with at least one treatment-emergent AE
|
46 Participants
|
|
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
Subjects with at least one related TEAE
|
33 Participants
|
|
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
Subjects discontinuing study drug due to an AE
|
7 Participants
|
|
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
Subjects with at least one SAE
|
5 Participants
|
|
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
Subjects with at least one life-threatening SAE
|
5 Participants
|
|
To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.
Subjects with AE leading to death
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 28 Weeks including safety follow-up visit.Population: Planned patient enrollment numbers were not achieved as this study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. No patient completed the 52 Week study treatment period prior to Sponsor termination of the study.
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a short questionnaire. Minimum range is 0 - Maximum range is 24. A score within the range 0-9 is considered to be normal while a score within the range of 10-24 would indicate that medical help should be solicited.
Outcome measures
| Measure |
Tozadenant
n=66 Participants
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Baseline
|
7.9 score on a scale
Standard Deviation 5.32
|
|
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Week 2
|
7.4 score on a scale
Standard Deviation 5.29
|
|
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Week 6
|
8.5 score on a scale
Standard Deviation 4.72
|
|
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Week 12
|
10.0 score on a scale
Standard Deviation 3.53
|
|
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Week 24
|
12.0 score on a scale
Standard Deviation 4.08
|
|
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Early Termination
|
7.9 score on a scale
Standard Deviation 5.08
|
|
To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.
Safety Follow-up
|
7.3 score on a scale
Standard Deviation 4.95
|
SECONDARY outcome
Timeframe: Up to 28 Weeks including safety follow-up visit.Population: Planned patient enrollment numbers were not achieved as this study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. No patient completed the 52 Week study treatment period prior to Sponsor termination of the study.
The Columbia Suicide Severity Rating Scale (C-SSRS) is a standardized suicidality rating system. The interview measures presence of suicidality and consists of 4 categories: suicidal ideation, intensity of ideation, suicidal behavior, and actual/potential lethality. Suicidal Ideation - A series of 1 -5 questions with 5 types of ideation of increasing severity. Score of Yes = 1, No= 0. A positive answer to question 4 (active suicidal ideation with some intent to act) or 5 (active suicidal ideation with specific plan and intent) indicates that the individual has some intent to act on suicidal thoughts and will need further evaluation. Suicidal Behavior - Different types of suicidal behavior are scored (Yes=1, No=0) and identify the occurrence of actual, interrupted, or aborted attempts; preparatory behaviors; and suicide. The total number of each type of suicidal behavior show the density of suicide, (more behaviors represent a higher degree of risk).
Outcome measures
| Measure |
Tozadenant
n=66 Participants
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Lifetime: Actual attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Lifetime: Interrupted attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Lifetime: Aborted attempts
|
3 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Past 5 years: Actual attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Past 5 years: Interrupted attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Past 5 years: Aborted attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Past 6 months: Actual attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Past 6 months: Interrupted attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Screening - Past 6 months: Aborted attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Baseline - Since last visit: Actual attempts
|
3 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Baseline - Since last visit: Interrupted attempts
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Baseline - Since last visit: Aborted attempts
|
3 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 2 - Since last visit: Actual attempts
|
3 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 2 - Since last visit: Interrupted attempts
|
3 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 2 - Since last visit: Aborted attempts
|
3 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 6 - Since last visit: Actual attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 6 - Since last visit: Interrupted attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 6 - Since last visit: Aborted attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 12 - Since last visit: Actual attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 12 - Since last visit: Interrupted attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 12 - Since last visit: Aborted attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 24 - Since last visit: Actual attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 24 - Since last visit: Interrupted attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Week 24 - Since last visit: Aborted attempts
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Early Termination: Actual attempts
|
10 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Early Termination: Interrupted attempts
|
10 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Early Termination: Aborted attempts
|
10 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Safety Follow-up: Actual attempts
|
8 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Safety Follow-up: Interrupted attempts
|
8 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.
Safety Follow-up: Aborted attempts
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 28 Weeks including safety follow-up visit.Population: Planned patient enrollment numbers were not achieved as this study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. No patient completed the 52 Week study treatment period prior to Sponsor termination of the study. .
The Minnesota Impulsive Disorders Interview (MIDI) 8 is a global instrument that includes questions for compulsive gambling, buying, and sexual behavior (as well as other disorders not reported to occur in PD). The mMIDI consists of 5 modules: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding. Positive Answer: Any answer other than "no" on any question is considered a "yes"/positive answer. Negative Module: A module is considered negative if the patient's answer to a gateway (initial) question is "no" or if a patient answers "yes" to a gateway question and "no" to all of the remaining answers after the gateway question in that module. Positive Module: A module is considered positive if a patient gives a positive answer (No = 0, rarely = 1, occasionally = 2, frequently = 3) to any question after the gateway (initial) question in one or more of the 5 modules.
Outcome measures
| Measure |
Tozadenant
n=66 Participants
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 24 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Screening · Negative
|
66 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Screening · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 2 · Negative
|
59 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 2 · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 6 · Negative
|
43 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 6 · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 12 · Negative
|
22 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 12 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 24 · Negative
|
4 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Week 24 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Early Termination · Negative
|
60 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Early Termination · Positive
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Safety Follow-up · Negative
|
56 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Buying Disorder - Safety Follow-up · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Screening · Negative
|
65 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Screening · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 2 · Negative
|
59 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 2 · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 6 · Negative
|
44 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 6 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 12 · Negative
|
22 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 12 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Week 24 · Negative
|
4 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Early Termination · Negative
|
61 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Early Termination · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Safety Follow-up · Negative
|
56 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Gambling - Safety Follow-up · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Screening · Negative
|
66 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Screening · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 2 · Negative
|
60 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 2 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 6 · Negative
|
44 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 6 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 12 · Negative
|
22 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 12 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 24 · Negative
|
4 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Week 24 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Early Termination · Negative
|
60 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Early Termination · Positive
|
2 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Safety Follow-up · Negative
|
56 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Sexual Behavior - Safety Follow-up · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Screening · Negative
|
66 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Screening · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 2 · Negative
|
60 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 2 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 6 · Negative
|
43 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 6 · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 12 · Negative
|
22 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 12 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 24 · Negative
|
4 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Week 24 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Early Termination · Negative
|
61 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Early Termination · Positive
|
1 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Safety Follow-up · Negative
|
57 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Compulsive Eating Module - Safety Follow-up · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Screening · Negative
|
66 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Screening · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 2 · Negative
|
60 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 2 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 6 · Negative
|
44 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 6 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 12 · Negative
|
22 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 12 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 24 · Negative
|
4 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Week 24 · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Early Termination · Negative
|
62 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Early Termination · Positive
|
0 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Safety Follow-up · Negative
|
57 Participants
|
|
To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)
Punding Behavior - Safety Follow-up · Positive
|
0 Participants
|
Adverse Events
Tozadenant
Serious events: 5 serious events
Other events: 46 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Tozadenant
n=66 participants at risk
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Infections and infestations
Abdominal abscess
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Infections and infestations
Atypical pneumonia
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Infections and infestations
Diverticulitis
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Infections and infestations
Septic shock
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
Other adverse events
| Measure |
Tozadenant
n=66 participants at risk
120 mg twice daily. At Week 2 or thereafter doses of 60 mg BID and 120 mg BID will be permitted.
Tozadenant: 1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
|
|---|---|
|
Nervous system disorders
Dyskinesia
|
25.8%
17/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Injury, poisoning and procedural complications
Fall
|
10.6%
7/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
6/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
4/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
3/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Psychiatric disorders
Hallucination
|
4.5%
3/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
3/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Nervous system disorders
Parkinson's Disease
|
4.5%
3/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Psychiatric disorders
Anxiety
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Investigations
Blood creatinine increased
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Investigations
Blood glucose increased
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Investigations
Blood pressure increased
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Injury, poisoning and procedural complications
Drug administration error
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Nervous system disorders
Headache
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Vascular disorders
Hypertension
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Psychiatric disorders
Insomnia
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Vascular disorders
Orthostatic hypotension
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Nervous system disorders
Tremor
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
2/66 • This study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. Due to Sponsor termination of the study, Adverse Events were collected up to Week 24.
|
Additional Information
Christopher Kenney, Senior Vice President - Medical Affairs
Acorda Therapeutics
Phone: 9143265775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER