Trial Outcomes & Findings for A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants (NCT NCT02337751)
NCT ID: NCT02337751
Last Updated: 2022-03-02
Results Overview
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
198 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2022-03-02
Participant Flow
Participants took part in the study at 68 investigative sites in Japan, from 10 July 2015 to 14 March 2017.
All participants with Parkinson's disease who completed the 26-week treatment period in preceding study (TVP-1012/CCT-001: NCT02337725) were enrolled in this study. Participants in TVP-1012 group and in Placebo group in preceding study were assigned to TVP-1012+TVP-1012 Group and Placebo+TVP-1012 Group in this study, respectively.
Participant milestones
| Measure |
Placebo + TVP-1012 Group
TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to Placebo group in preceding study.
|
TVP-1012 + TVP-1012 Group
TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to TVP-1012 group in preceding study.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
103
|
|
Overall Study
COMPLETED
|
84
|
87
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
| Measure |
Placebo + TVP-1012 Group
TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to Placebo group in preceding study.
|
TVP-1012 + TVP-1012 Group
TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to TVP-1012 group in preceding study.
|
|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
2
|
3
|
|
Overall Study
Voluntary Withdrawal
|
6
|
8
|
|
Overall Study
Lack of Efficacy
|
2
|
5
|
|
Overall Study
Investigator's Judgement
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo + TVP-1012 Group
n=95 Participants
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 Participants
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks.
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 9.13 • n=95 Participants
|
67.4 Years
STANDARD_DEVIATION 8.99 • n=117 Participants
|
66.5 Years
STANDARD_DEVIATION 9.09 • n=212 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=95 Participants
|
64 Participants
n=117 Participants
|
117 Participants
n=212 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=95 Participants
|
53 Participants
n=117 Participants
|
95 Participants
n=212 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
95 Participants
n=95 Participants
|
117 Participants
n=117 Participants
|
212 Participants
n=212 Participants
|
|
Height
|
159.2 Centimeters (cm)
STANDARD_DEVIATION 9.28 • n=95 Participants
|
158.9 Centimeters (cm)
STANDARD_DEVIATION 8.87 • n=117 Participants
|
159.0 Centimeters (cm)
STANDARD_DEVIATION 9.04 • n=212 Participants
|
|
Weight
|
56.68 Kilograms (kg)
STANDARD_DEVIATION 9.773 • n=95 Participants
|
57.91 Kilograms (kg)
STANDARD_DEVIATION 11.803 • n=117 Participants
|
57.36 Kilograms (kg)
STANDARD_DEVIATION 10.932 • n=212 Participants
|
|
BMI
|
22.28 kg/meter (m)^2
STANDARD_DEVIATION 2.798 • n=95 Participants
|
22.78 kg/meter (m)^2
STANDARD_DEVIATION 3.303 • n=117 Participants
|
22.56 kg/meter (m)^2
STANDARD_DEVIATION 3.090 • n=212 Participants
|
|
Smoking Classification
Never Smoked
|
56 Participants
n=95 Participants
|
63 Participants
n=117 Participants
|
119 Participants
n=212 Participants
|
|
Smoking Classification
Current Smoker
|
7 Participants
n=95 Participants
|
5 Participants
n=117 Participants
|
12 Participants
n=212 Participants
|
|
Smoking Classification
Ex-Smoker
|
32 Participants
n=95 Participants
|
49 Participants
n=117 Participants
|
81 Participants
n=212 Participants
|
|
Timing of Study Drug Dose
Before Breakfast
|
48 Participants
n=95 Participants
|
59 Participants
n=117 Participants
|
107 Participants
n=212 Participants
|
|
Timing of Study Drug Dose
After Breakfast
|
47 Participants
n=95 Participants
|
58 Participants
n=117 Participants
|
105 Participants
n=212 Participants
|
|
Duration of Parkinson's Disease
|
1.52 Years
STANDARD_DEVIATION 1.223 • n=95 Participants
|
1.97 Years
STANDARD_DEVIATION 1.981 • n=117 Participants
|
1.77 Years
STANDARD_DEVIATION 1.695 • n=212 Participants
|
|
Modified Hoehn & Yahr Stage
|
2.13 Units on a scale
STANDARD_DEVIATION 0.627 • n=95 Participants
|
2.18 Units on a scale
STANDARD_DEVIATION 0.628 • n=117 Participants
|
2.16 Units on a scale
STANDARD_DEVIATION 0.627 • n=212 Participants
|
|
MDS-UPDRS Part II + Part III Total Score (Pre-Dose)
|
33.0 Scores on a scale
STANDARD_DEVIATION 15.86 • n=95 Participants
|
34.4 Scores on a scale
STANDARD_DEVIATION 16.95 • n=117 Participants
|
33.8 Scores on a scale
STANDARD_DEVIATION 16.44 • n=212 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Outcome measures
| Measure |
Placebo + TVP-1012 Group
n=95 Participants
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 Participants
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
51 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Outcome measures
| Measure |
Placebo + TVP-1012 Group
n=95 Participants
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 Participants
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
C-Reactive Protein Increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Glycosylated Haemoglobin Increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Liver Function Test Abnormal
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Liver Function Test Increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
White Blood Cell Count Increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood Creatine Phosphokinase Increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood Triglycerides Increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood Urine Present
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants. The number of participants analyzed for each items are participants evaluable for each item within the safety analysis set.
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Here "mmHg" is Millimeter of mercury. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Outcome measures
| Measure |
Placebo + TVP-1012 Group
n=95 Participants
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 Participants
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Temperature <35.6 Celsius (ºC)
|
13 Participants
|
30 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Temperature >37.7 ºC
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Diastolic Blood Pressure <50 mmHg
|
4 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Diastolic Blood Pressure >100 mmHg
|
6 Participants
|
13 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Pulse <45 Beats per Minute (bpm)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Systolic Blood Pressure <90 mmHg
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Outcome measures
| Measure |
Placebo + TVP-1012 Group
n=95 Participants
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 Participants
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).
Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Outcome measures
| Measure |
Placebo + TVP-1012 Group
n=95 Participants
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 Participants
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Number of Participants With TEAE Related to Body Weight (Weight Loss)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of treatment (Week 52)Population: Full Analysis Set (FAS); All randomized participants who received at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Outcome measures
| Measure |
Placebo + TVP-1012 Group
n=95 Participants
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 Participants
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
|
-2.8 Units on a Scale
Standard Deviation 6.01
|
-2.8 Units on a Scale
Standard Deviation 9.62
|
Adverse Events
Placebo + TVP-1012 Group
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
TVP-1012 + TVP-1012 Group
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + TVP-1012 Group
n=95 participants at risk
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 participants at risk
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.85%
1/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.00%
0/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.85%
1/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Gastrointestinal disorders
Mechanical ileus
|
1.1%
1/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.00%
0/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.85%
1/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.85%
1/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.85%
1/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.00%
0/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
1/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.00%
0/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.85%
1/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Vascular disorders
Microscopic polyangiitis
|
1.1%
1/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
0.00%
0/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
Other adverse events
| Measure |
Placebo + TVP-1012 Group
n=95 participants at risk
Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
TVP-1012 + TVP-1012 Group
n=117 participants at risk
TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.9%
17/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
26.5%
31/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Injury, poisoning and procedural complications
Fall
|
6.3%
6/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
9.4%
11/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
5/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
4.3%
5/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Nervous system disorders
Headache
|
1.1%
1/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
6.0%
7/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.1%
2/95 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
7.7%
9/117 • Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER