A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02337751
• Collaborator: (none)
• Enrollment: 198
• Locations: 56
• Arm: 1
• Actual Duration (Months): 20.1
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in Japanese participants with early Parkinson's disease.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: TVP-1012 1mg	Phase 3

Detailed Description

This is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg for another 26 weeks in participants with early Parkinson's disease who have completed the preceding TVP-1012/CCT-001 (NCT02337725) study.

Among participants of the TVP-1012/CCT-001 study, those consenting to participate in this study prior to complete the preceding study and fulfilling the eligibility criteria will be enrolled in this study. From the day after the Visit 8 of the preceding study, participants will receive 1 mg of TVP-1012 once daily for 26 weeks in an unblinded manner.

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa
• Actual Study Start Date: Jul 10, 2015
• Actual Primary Completion Date: Mar 14, 2017
• Actual Study Completion Date: Mar 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TVP-1012 1mg Group TVP-1012 (1 mg/day) once daily, either before or after breakfast.	Drug: TVP-1012 1mg; TVP-1012 1mg Tablets

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) [Up to 52 weeks]

   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).

Secondary Outcome Measures

1. Number of Participants With TEAE Related to Clinical Laboratory Tests [Up to 52 weeks]

   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).

2. Number of Participants With Markedly Abnormal Vital Signs Values [Up to 52 weeks]

   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).

3. Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged) [Up to 52 weeks]

   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).

4. Number of Participants With TEAE Related to Body Weight (Weight Loss) [Up to 52 weeks]

   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).

5. Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score [Baseline to End of treatment (Week 52)]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The participant has completed the preceding study.

• The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator.

Exclusion Criteria:

• The participant has undergone blood collection of >= 400 mL within 90 days prior to the start of treatment in this study.

• The participant is required to take any of the excluded medications or treatments.

• The participant is required surgery or hospitalization for surgery during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Nagoya	Aichi	Japan
2		Matsuyama	Ehime	Japan
3		Toon	Ehime	Japan
4		Kitakyushu	Fukuoka	Japan
5		Onojo	Fukuoka	Japan
6		Asahikawa	Hokkaido	Japan
7		Iwamizawa	Hokkaido	Japan
8		Akashi	Hyogo	Japan
9		Kobe	Hyogo	Japan
10		Tsuchiura	Ibaraki	Japan
11		Tsukuba	Ibaraki	Japan
12		Ichinoseki	Iwate	Japan
13		Morioka	Iwate	Japan
14		Takamatsu	Kagawa	Japan
15		Fujisawa	Kanagawa	Japan
16		Sagamihara	Kanagawa	Japan
17		Yokohama	Kanagawa	Japan
18		Goshi	Kumamoto	Japan
19		Sendai	Miyagi	Japan
20		Matsumoto	Nagano	Japan
21		Higashisonogi	Nagasaki	Japan
22		Nishisonogi	Nagasaki	Japan
23		Tenri	Nara	Japan
24		Joetsu	Niigata	Japan
25		Higashiosaka	Osaka	Japan
26		Suita	Osaka	Japan
27		Takatsuki	Osaka	Japan
28		Toyonaka	Osaka	Japan
29		Irima	Saitama	Japan
30		Fuji	Shizuoka	Japan
31		Hamamatsu	Shizuoka	Japan
32		Izunokuni	Shizuoka	Japan
33		Shimono	Tochigi	Japan
34		Yoshinogawa	Tokushima	Japan
35		Bunkyo-ku	Tokyo	Japan
36		Fuchu	Tokyo	Japan
37		Kodaira	Tokyo	Japan
38		Meguro-ku	Tokyo	Japan
39		Nerima-ku	Tokyo	Japan
40		Ota-ku	Tokyo	Japan
41		Setagaya-ku	Tokyo	Japan
42		Shibuya-ku	Tokyo	Japan
43		Akita		Japan
44		Aomori		Japan
45		Fukuoka		Japan
46		Fukushima		Japan
47		Hiroshima		Japan
48		Kochi		Japan
49		Kyoto		Japan
50		Niigata		Japan
51		Okayama		Japan
52		Osaka		Japan
53		Tokushima		Japan
54		Toyama		Japan
55		Wakayama		Japan
56		Yamagata		Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

• Study Protocol - Mar 24, 2016
• Statistical Analysis Plan - Apr 11, 2017

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02337751
• Other Study ID Numbers: TVP-1012/OCT-001; U1111-1165-1437; JapicCTI-152761
• First Posted: Jan 14, 2015
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 68 investigative sites in Japan, from 10 July 2015 to 14 March 2017.
Pre-assignment Detail	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.

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 + TVP-1012 Group
Arm/Group Description	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 (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.
Period Title: Overall Study
STARTED	95	103
COMPLETED	84	87
NOT COMPLETED	11	16

Baseline Characteristics

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 + TVP-1012 Group	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	95	117	212
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	65.4 (9.13)	67.4 (8.99)	66.5 (9.09)
Sex: Female, Male (Count of Participants)
Female	53 55.8%	64 54.7%	117 55.2%
Male	42 44.2%	53 45.3%	95 44.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Number) [Number]
Japan	95 100%	117 100%	212 100%
Height (Centimeters (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeters (cm)]	159.2 (9.28)	158.9 (8.87)	159.0 (9.04)
Weight (Kilograms (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms (kg)]	56.68 (9.773)	57.91 (11.803)	57.36 (10.932)
BMI (kg/meter (m)^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/meter (m)^2]	22.28 (2.798)	22.78 (3.303)	22.56 (3.090)
Smoking Classification (Count of Participants)
Never Smoked	56 58.9%	63 53.8%	119 56.1%
Current Smoker	7 7.4%	5 4.3%	12 5.7%
Ex-Smoker	32 33.7%	49 41.9%	81 38.2%
Timing of Study Drug Dose (Count of Participants)
Before Breakfast	48 50.5%	59 50.4%	107 50.5%
After Breakfast	47 49.5%	58 49.6%	105 49.5%
Duration of Parkinson's Disease (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	1.52 (1.223)	1.97 (1.981)	1.77 (1.695)
Modified Hoehn & Yahr Stage (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	2.13 (0.627)	2.18 (0.628)	2.16 (0.627)
MDS-UPDRS Part II + Part III Total Score (Pre-Dose) (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	33.0 (15.86)	34.4 (16.95)	33.8 (16.44)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Description	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).
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 + TVP-1012 Group
Arm/Group Description	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 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.
Measure Participants	95	117
Count of Participants [Participants]	51 53.7%	91 77.8%

2. Secondary Outcome

Title	Number of Participants With TEAE Related to Clinical Laboratory Tests
Description	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).
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 + TVP-1012 Group
Arm/Group Description	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 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.
Measure Participants	95	117
Blood Creatine Phosphokinase Increased	0 0%	1 0.9%
Blood Triglycerides Increased	1 1.1%	0 0%
Blood Urine Present	1 1.1%	0 0%
C-Reactive Protein Increased	0 0%	1 0.9%
Glycosylated Haemoglobin Increased	0 0%	1 0.9%
Liver Function Test Abnormal	0 0%	1 0.9%
Liver Function Test Increased	0 0%	1 0.9%
White Blood Cell Count Increased	1 1.1%	0 0%

3. Secondary Outcome

Title	Number of Participants With Markedly Abnormal Vital Signs Values
Description	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).
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 + TVP-1012 Group
Arm/Group Description	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 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.
Measure Participants	95	117
Temperature <35.6 Celsius (ºC)	13 13.7%	30 25.6%
Temperature >37.7 ºC	0 0%	1 0.9%
Systolic Blood Pressure <90 mmHg	3 3.2%	3 2.6%
Diastolic Blood Pressure <50 mmHg	4 4.2%	0 0%
Diastolic Blood Pressure >100 mmHg	6 6.3%	13 11.1%
Pulse <45 Beats per Minute (bpm)	0 0%	1 0.9%

4. Secondary Outcome

Title	Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)
Description	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).
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 + TVP-1012 Group
Arm/Group Description	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 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.
Measure Participants	95	117
Count of Participants [Participants]	1 1.1%	1 0.9%

5. Secondary Outcome

Title	Number of Participants With TEAE Related to Body Weight (Weight Loss)
Description	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).
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 + TVP-1012 Group
Arm/Group Description	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 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.
Measure Participants	95	117
Count of Participants [Participants]	1 1.1%	0 0%

6. Secondary Outcome

Title	Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
Description	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).
Time Frame	Baseline to End of treatment (Week 52)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo + TVP-1012 Group	TVP-1012 +TVP-1012 Group
Arm/Group Description	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 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.
Measure Participants	95	117
Mean (Standard Deviation) [Units on a Scale]	-2.8 (6.01)	-2.8 (9.62)

Adverse Events

Time Frame	Up to 52 weeks
Adverse Event Reporting Description	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.
Arm/Group Title	Placebo + TVP-1012 Group		TVP-1012 + TVP-1012 Group
Arm/Group Description	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 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.
All Cause Mortality
	Placebo + TVP-1012 Group		TVP-1012 + TVP-1012 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/117 (0%)
Serious Adverse Events
	Placebo + TVP-1012 Group		TVP-1012 + TVP-1012 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/95 (4.2%)		6/117 (5.1%)
Gastrointestinal disorders
Inguinal hernia	0/95 (0%)		1/117 (0.9%)
Leukoplakia oral	0/95 (0%)		1/117 (0.9%)
Mechanical ileus	1/95 (1.1%)		0/117 (0%)
Hepatobiliary disorders
Hepatic function abnormal	0/95 (0%)		1/117 (0.9%)
Injury, poisoning and procedural complications
Femoral neck fracture	0/95 (0%)		1/117 (0.9%)
Spinal compression fracture	0/95 (0%)		1/117 (0.9%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/95 (1.1%)		0/117 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/95 (1.1%)		0/117 (0%)
Nervous system disorders
Intracranial aneurysm	0/95 (0%)		1/117 (0.9%)
Vascular disorders
Microscopic polyangiitis	1/95 (1.1%)		0/117 (0%)
Other (Not Including Serious) Adverse Events
	Placebo + TVP-1012 Group		TVP-1012 + TVP-1012 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/95 (24.2%)		49/117 (41.9%)
Infections and infestations
Nasopharyngitis	17/95 (17.9%)		31/117 (26.5%)
Injury, poisoning and procedural complications
Fall	6/95 (6.3%)		11/117 (9.4%)
Contusion	5/95 (5.3%)		5/117 (4.3%)
Nervous system disorders
Headache	1/95 (1.1%)		7/117 (6%)
Skin and subcutaneous tissue disorders
Eczema	2/95 (2.1%)		9/117 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.