Trial Outcomes & Findings for A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants (NCT NCT02337764)
NCT ID: NCT02337764
Last Updated: 2022-03-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
Up to Week 52
Results posted on
2022-03-02
Participant Flow
Participants took part in the study at 25 investigative sites in Japan, from 03-Feb-2015 to 29-Sep-2016.
Participants with diagnosis of Parkinson's disease were enrolled in run- in period (Week -2 to 0). After that, the participants who fulfilled the inclusion criteria and did not meet any of the exclusion criteria at Week -2 and 0 were enrolled in the study and received TVP-1012 1 mg in an unblinded manner, from the day after Week 0.
Participant milestones
| Measure |
TVP-1012 1 mg
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Overall Study
STARTED
|
222
|
|
Overall Study
COMPLETED
|
162
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
TVP-1012 1 mg
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
46
|
|
Overall Study
Voluntary Withdrawal
|
12
|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
The number analyzed is the number of participants with data available for analysis.
Baseline characteristics by cohort
| Measure |
TVP-1012 1 mg
n=222 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Age, Continuous
|
68.0 Years
STANDARD_DEVIATION 8.41 • n=222 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=222 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=222 Participants
|
|
Region of Enrollment
Japan
|
222 Participants
n=222 Participants
|
|
Height
|
156.4 centimeter (cm)
STANDARD_DEVIATION 9.67 • n=222 Participants
|
|
Weight
|
55.86 kilogram (kg)
STANDARD_DEVIATION 12.292 • n=222 Participants
|
|
BMI
|
22.70 kg/m^2
STANDARD_DEVIATION 3.821 • n=222 Participants
|
|
Smoking Classification
Current Smoker
|
12 Participants
n=222 Participants
|
|
Smoking Classification
Ex-Smoker
|
80 Participants
n=222 Participants
|
|
Smoking Classification
Never Smoked
|
130 Participants
n=222 Participants
|
|
Timing of Study Drug Dose
Before Breakfast
|
106 Participants
n=222 Participants
|
|
Timing of Study Drug Dose
After Breakfast
|
116 Participants
n=222 Participants
|
|
Duration of Parkinson's Disease
|
7.09 Years
STANDARD_DEVIATION 5.022 • n=222 Participants
|
|
Duration of Levodopa Use
|
4.61 Years
STANDARD_DEVIATION 4.217 • n=222 Participants
|
|
Levodopa Total Daily Dose
|
355.0 miligram (mg)
STANDARD_DEVIATION 147.11 • n=222 Participants
|
|
Levodopa Frequency per Day
|
3.3 Times
STANDARD_DEVIATION 1.00 • n=222 Participants
|
|
Concomitant Use of COMT Inhibitor
Had COMT Inhibitor
|
75 Participants
n=222 Participants
|
|
Concomitant Use of COMT Inhibitor
Had no COMT Inhibitor
|
147 Participants
n=222 Participants
|
|
Concomitant Use of Dopamine Agonist
Had Dopamine Agonist
|
163 Participants
n=222 Participants
|
|
Concomitant Use of Dopamine Agonist
Had no Dopamine Agonist
|
59 Participants
n=222 Participants
|
|
Concomitant Use of Amantadine
Had Amantadine
|
54 Participants
n=222 Participants
|
|
Concomitant Use of Amantadine
Had no Amantadine
|
168 Participants
n=222 Participants
|
|
Concomitant Use of Anticholinergics
Had Anticholinergics
|
36 Participants
n=222 Participants
|
|
Concomitant Use of Anticholinergics
Had no Anticholinergics
|
186 Participants
n=222 Participants
|
|
Concomitant Use of Droxidopa
Had Droxidopa
|
15 Participants
n=222 Participants
|
|
Concomitant Use of Droxidopa
Had no Droxidopa
|
207 Participants
n=222 Participants
|
|
Concomitant Use of Istradefylline
Had Istradefylline
|
26 Participants
n=222 Participants
|
|
Concomitant Use of Istradefylline
Had no Istradefylline
|
196 Participants
n=222 Participants
|
|
Concomitant Use of Zonisamide
Had Zonisamide
|
36 Participants
n=222 Participants
|
|
Concomitant Use of Zonisamide
Had no Zonisamide
|
186 Participants
n=222 Participants
|
|
Wearing Off Phenomenon
Had Wearing Off Phenomenon
|
116 Participants
n=222 Participants
|
|
Wearing Off Phenomenon
Had no Wearing Off Phenomenon
|
106 Participants
n=222 Participants
|
|
Duration of Wearing Off Phenomenon
|
3.02 Years
STANDARD_DEVIATION 2.747 • n=116 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Modified Hoehn & Yahr Stage (ON State)
|
2.47 Units on a scale
STANDARD_DEVIATION 0.688 • n=116 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Modified Hoehn & Yahr Stage (OFF State)
|
3.19 Units on a scale
STANDARD_DEVIATION 0.700 • n=116 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Mean Daily OFF-time
|
4.99 Hours
STANDARD_DEVIATION 3.263 • n=111 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Modified Hoehn & Yahr Stage
|
2.42 Units on a scale
STANDARD_DEVIATION 0.708 • n=106 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
MDS-UPDRS Part II Total Score
|
11.9 Scores on a scale
STANDARD_DEVIATION 7.28 • n=222 Participants
|
|
MDS-UPDRS Part III Total Score
|
28.8 Scores on a scale
STANDARD_DEVIATION 13.14 • n=222 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
TVP-1012 1 mg
n=222 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
185 Participants
|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
39 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
TVP-1012 1 mg
n=222 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood creatine phosphokinase increased
|
7 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Gamma-glutamyltransferase increased
|
4 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood alkaline phosphatase increased
|
3 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood lactate dehydrogenase increased
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Blood uric acid increased
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Liver function test value increased
|
1 Participants
|
|
Number of Participants With TEAE Related to Clinical Laboratory Tests
Urine ketone body present
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Analysis set included all participants who received at least 1 dose of study drug. Here number of participants analyzed are participants evaluable for this outcome measure.
Outcome measures
| Measure |
TVP-1012 1 mg
n=221 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Temperature (<35.6 °C)
|
40 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Temperature(>37.7 °C)
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Systolic Blood Pressure (<90 mmHg)
|
33 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Systolic Blood Pressure (>180 mmHg)
|
6 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Diastolic Blood Pressure(<50 mmHg)
|
31 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Diastolic Blood Pressure (>100 mmHg)
|
6 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Pulse (<45 bpm)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
TVP-1012 1 mg
n=222 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Supraventricular extrasystoles
|
1 Participants
|
|
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Atrial fibrillation
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
TVP-1012 1 mg
n=222 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Number of Participants With TEAE Related to Body Weight (Weight Decreased)
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (LOCF)Population: Full Analysis Set included all participants who received at least 1 dose of the study drug. Here number of participants analyzed are participants evaluable for this outcome measure.
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.
Outcome measures
| Measure |
TVP-1012 1 mg
n=218 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score
|
0.0 Units on a scale
Standard Deviation 5.08
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (LOCF)Population: Full Analysis Set included all participants who received at least 1 dose of the study drug. Here number of participants analyzed are participants evaluable for this outcome measure.
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.
Outcome measures
| Measure |
TVP-1012 1 mg
n=215 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Change From Baseline in MDS-UPDRS Part III Total Score
|
-7.6 Units on a scale
Standard Deviation 10.45
|
SECONDARY outcome
Timeframe: Baseline and Week 52 (LOCF)Population: Full Analysis Set included all participants who received at least 1 dose of the study drug. Here number of participants analyzed are participants evaluable for this outcome measure.
Off-time refers to times when levodopa is not working well, causing worsening symptoms.
Outcome measures
| Measure |
TVP-1012 1 mg
n=106 Participants
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Change From Baseline to Week 52 (LOCF) in Mean Daily OFF-time
|
-0.89 Hours
Standard Deviation 2.537
|
Adverse Events
TVP-1012 1 mg
Serious events: 39 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TVP-1012 1 mg
n=222 participants at risk
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Retinal detachment
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Decreased activity
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bacterial infection
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.4%
3/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.90%
2/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.90%
2/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.90%
2/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Parkinson's disease
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Parkinsonian gait
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hallucination
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hallucination, visual
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Aortic dissection
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.45%
1/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
TVP-1012 1 mg
n=222 participants at risk
For 2 weeks during the run-in period, followed by 52 weeks during the treatment period, TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
14.0%
31/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
37/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.1%
18/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dyskinesia
|
10.8%
24/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
5.0%
11/222 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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