Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03661983
• Collaborator: (none)
• Enrollment: 36
• Locations: 42
• Arms: 4
• Actual Duration (Months): 20.6
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).

Condition or Disease	Intervention/Treatment	Phase
Tourette's Disorder (TD)	Drug: Aripiprazole; Drug: Placebo	Phase 4

Detailed Description

This study will evaluate the long-term efficacy of oral aripiprazole in the treatment of pediatric participants with Tourette's Disorder (TD). The trial consists of 3 distinct phases: a pretreatment phase, open-label stabilization phase, and a double-blind randomized withdrawal phase.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette's Disorder
• Actual Study Start Date: Oct 13, 2018
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Label Stabilization Phase: Aripiprazole Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.	Drug: Aripiprazole; Participants received aripiprazole tablets, orally as per the regimen specified in the arm description.; Other Names: OPC-14597
Experimental: Double Blind Phase: Aripiprazole Full Dose Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for <50 kg participants,and 10 mg or 20 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.	Drug: Aripiprazole; Participants received aripiprazole tablets, orally as per the regimen specified in the arm description.; Other Names: OPC-14597
Experimental: Double Blind Phase: Aripiprazole Half Dose Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for <50 kg participants, and 5 mg or 10 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.	Drug: Aripiprazole; Participants received aripiprazole tablets, orally as per the regimen specified in the arm description.; Other Names: OPC-14597
Placebo Comparator: Double Blind Phase: Placebo Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.	Drug: Placebo; Participants received aripiprazole matching-placebo tablets, orally as per the regimen specified in the arm description.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Relapse During the Double-blind Randomized Withdrawal Phase [From Randomization up to 12 weeks in Double-blind Randomized Withdrawal Phase]

   Relapse was defined as a loss of ≥ 50% of the improvement experienced during the open-label stabilization phase (i.e., improvement at the last assessment of Yale Global Tic Severity Scale (YGTSS) before randomization) on the Yale Global Tic Severity Scale Total Tic Score (YGTSS TTS). YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The participant is a male or female child or adolescent, 6 to 17 years of age (inclusive) at the time of signing the informed consent/assent.

• The participant meets current Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic criteria for TD, documented at screening and made by an adequately trained clinician, as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version.

• The participant has a Total Tic Score (TTS) ≥ 20 on the Yale Global Tic Severity Scale (YGTSS) at screening and baseline (Day 1).

• The participant, a caregiver, and the investigator must all agree that the presenting tic symptoms cause impairment in the participant's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships.

• Females of childbearing potential (all female participants ≥ 12 years of age and all female participants < 12 years of age if menstruation has started) must have a negative pregnancy test and must not be pregnant or lactating.

• Written informed consent must be obtained from the participant or a legally acceptable representative (eg, guardian or caregiver), in accordance with requirements of the trial site's institutional review board (IRB)/independent ethics committee (IEC) and local regulatory requirements, prior to the initiation of any protocol-required procedures. In addition, the participant, as required by the trial center's IRB/IEC, must provide informed assent at screening and as such must be able to understand that he or she can withdraw from the trial at any time.

• Ability, in the opinion of the principal investigator, of the participant and the participant's legally acceptable representative (e.g., guardian) or caregiver(s) to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications, to read and understand the written word in order to complete participant-reported outcomes measures, and to be reliably rated on assessment scales.

Exclusion Criteria:

• The participant presents with a clinical presentation and/or history that is consistent with another neurologic condition that may have accompanying abnormal movements. These include, but are not limited to, the following: Transient tic disorder; Huntington's disease; Parkinson's disease; Sydenham's chorea; Wilson's disease; Mental retardation; Pervasive developmental disorder; Tardive dyskinesia; Traumatic brain injury; Stroke; Restless legs syndrome.

• The participant has a history of schizophrenia, bipolar disorder, or other psychotic disorder.

• Participants who receive psychostimulants for the treatment of attention-deficit hyperactivity disorder (ADHD) and who have developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment. (Note that participants with ADHD who are treated with psychostimulants and have not developed new tics or a worsening of their current tics can be included if all other enrollment obligations are met).

• The participant currently has a primary diagnosis that meets DSM-5 criteria for mood disorder.

• The participant has severe obsessive-compulsive disease, as evidenced by a Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score > 16.

• The participant has taken aripiprazole within 1 month (30 days) of the screening visit.

• The participant has a history of neuroleptic malignant syndrome.

• Participant is a sexually active male or female of childbearing potential (FOCBP) (all female participants ≥ 12 years of age and all female participants < 12 years of age if menstruation has started) who will not agree to practice 2 acceptable methods of birth control or who will not remain abstinent during the trial and for 30 or 90 days following the last dose of Investigational medicinal product (IMP) for females and males, respectively. Abstinence will be permitted if it is confirmed and documented at every trial visit.

• The participant represents a significant risk of committing suicide based on history (suicide attempt in past 1 year).

• The participant has a body weight < 16 kg.

• Participants who have taken neuroleptic or antiparkinson drugs within 14 days prior to baseline.

• Participants requiring cognitive-behavioral therapy (CBT) for TD during the trial period. CBT for other nonexclusionary disorder must remain consistent through the trial.

• The participant has met DSM-5 criteria for any significant psychoactive substance use disorder within the past 3 months.

• A positive drug screen for cocaine, alcohol, or other drugs of abuse (excluding caffeine, nicotine, or prescribed psychostimulants for ADHD). Investigators can choose to repeat a positive drug screen one time during screening period after concurrence from the medical monitor. A second positive test for any drug of abuse would be exclusionary.

• Participant requiring medication not allowed per protocol.

• Use of any cytochrome P450 (CYP)2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to baseline and for the duration of the trial.

• Other nutritional or dietary supplements and nonprescription herbal preparations for TD (eg, cannabinoids, N-acetylcysteine, omega-3 fatty acids, kava extracts, GABA supplements) within 7 days prior to baseline and for the duration of the trial, unless approved in advance by the medical monitor.

• The inability to swallow tablets or tolerate oral medication.

• Participant has participated in a clinical trial involving either study medication or interventional (non-medication) treatment for TD within the last 60 days.

• The following laboratory test results, vital signs and electrocardiogram (ECG) results are exclusionary: Platelets ≤ 75,000/mm^{3; Hemoglobin ≤ 9 g/dL; Neutrophils, absolute ≤ 1000/mm}3; Aspartate aminotransferase > 3 × upper limit of normal (ULN) as defined by the central laboratory; Alanine aminotransferase > 3 × ULN as defined by the central laboratory; Creatinine ≥ 2 mg/dL; Diastolic blood pressure > 105 mmHg; Corrected QT interval ≥ 450 msec (males) or ≥ 470 msec (females) using the corrected QT interval for heart rate using Fridericia's formula

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Research Center	Anaheim	California	United States	92805
2	CT Trials - Riverside	Riverside	California	United States	92506
3	Syrentis Clinical Research	Santa Ana	California	United States	92705
4	Comprehensive Research Center	Norwich	Connecticut	United States	06360
5	Sarkis Clinical	Gainesville	Florida	United States	32607
6	Reliable Clinical Research	Hialeah	Florida	United States	33012
7	Eastern Research	Hialeah	Florida	United States	33013
8	Rothman Center for Pediatric Neuropsychiatry	Saint Petersburg	Florida	United States	33701
9	Quest Pharmaceutical Services - Miami Research Associates	South Miami	Florida	United States	33143
10	Pediatric and Adolescent Neurodevelopment Associates	Atlanta	Georgia	United States	30328
11	Inova Clinical trials and Research Center	Fayetteville	Georgia	United States	30214
12	Baber Research Group	Naperville	Illinois	United States	60563
13	Neurobehavioral Medicine Group	Bloomfield Hills	Michigan	United States	48302
14	Alivation	Lincoln	Nebraska	United States	68526
15	The NeuroCognitive Institute	Mount Arlington	New Jersey	United States	07856
16	Manhattan Behavioral Medicine	New York	New York	United States	10036
17	Mood Disorders Consulting Medicine	New York	New York	United States	10036
18	Finger Lakes Clinical Research	Rochester	New York	United States	14618
19	New Hope Clinical Research	Charlotte	North Carolina	United States	28211
20	Triangle Neuropsychiatry	Durham	North Carolina	United States	27707
21	Quest Therapeutics of Avon Lake DBA Haidar Almhana Nieding	Avon Lake	Ohio	United States	44012
22	University of Cincinnati	Cincinnati	Ohio	United States	45219
23	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
24	Charak Center for Health and Wellness	Garfield Heights	Ohio	United States	44125
25	North Star Medical Research	Middleburg Heights	Ohio	United States	44130
26	IPS Research	Oklahoma City	Oklahoma	United States	73103
27	ClinMed Research Associates, Inc.	Oklahoma City	Oklahoma	United States	73112
28	Rivus Wellness and Research Institute	Oklahoma City	Oklahoma	United States	73112
29	Sooner Clinical Research	Oklahoma City	Oklahoma	United States	73112
30	BioBehavioral Research of Austin	Austin	Texas	United States	78759
31	University Hills Clinical Research	Irving	Texas	United States	75062
32	Psychiatric Medical Associates	Plano	Texas	United States	75093
33	Clinical Trials of Texas	San Antonio	Texas	United States	78229
34	Aspen Clinical Research - Orem	Orem	Utah	United States	84058
35	University of Virginia School of Medicine	Charlottesville	Virginia	United States	22903
36	Clinical Research Partners - Richmond	Petersburg	Virginia	United States	23805
37	Core Clinical Research	Everett	Washington	United States	98201
38	Palouse Psychiatry & Behavioral Health	Spokane	Washington	United States	99202
39	Kids Clinic	Ajax	Ontario	Canada	L1Z 0M1
40	Jodha Tishon Inc.	Toronto	Ontario	Canada	M6J 3S3
41	Vadaskert Alaptvany A Gyermekek Lelki Egeszsegeert	Budapest		Hungary	1021
42	Semmelweis Egyetem - I. sz. Gyermekgyógyászati Klinika	Budapest		Hungary	1083

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

• Study Director: Eva Kohegyi, MD, MS, Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Documents (Full-Text)

• Study Protocol - Mar 4, 2019
• Statistical Analysis Plan - Jul 6, 2020

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT03661983
• Other Study ID Numbers: 31-14-204; 2018-002270-48
• First Posted: Sep 7, 2018
• Last Update Posted: Mar 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: Aripiprazole; Tourette's Disorder; Pediatric
• Additional relevant MeSH terms: Tourette Syndrome; Disease; Aripiprazole

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 13 investigative sites in Canada, the United States and Hungary from Oct 13, 2018 to Jun 30, 2020.
Pre-assignment Detail	Pediatric participants with a diagnosis of Tourette's Disorder were enrolled in this to receive oral aripiprazole in an Open-label Stabilization Phase and a Double-blind Randomized Withdrawal Phase and then followed for safety up to 30 days post-last dose.

Arm/Group Title	Open Label Stabilization Phase: Aripiprazole	Double Blind Phase: Aripiprazole Full Dose	Double Blind Phase: Aripiprazole Half Dose	Double Blind Phase: Placebo
Arm/Group Description	Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.	Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for <50 kg participants,and 10 mg or 20 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.	Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for <50 kg participants, and 5 mg or 10 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.	Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
Period Title: Open Label Stabilization Phase
STARTED	36	0	0	0
COMPLETED	25	0	0	0
NOT COMPLETED	11	0	0	0
Period Title: Open Label Stabilization Phase
STARTED	0	9	8	8
COMPLETED	0	7	7	0
NOT COMPLETED	0	2	1	8

Baseline Characteristics

Arm/Group Title	Open Label Stabilization Phase: Aripiprazole
Arm/Group Description	Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.9 (3.0)
Sex: Female, Male (Count of Participants)
Female	6 16.7%
Male	30 83.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 19.4%
Not Hispanic or Latino	29 80.6%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.8%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2.8%
White	32 88.9%
More than one race	0 0%
Unknown or Not Reported	2 5.6%
Region of Enrollment (participants) [Number]
Canada	9 25%
Hungary	4 11.1%
United States	23 63.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Relapse During the Double-blind Randomized Withdrawal Phase
Description	Relapse was defined as a loss of ≥ 50% of the improvement experienced during the open-label stabilization phase (i.e., improvement at the last assessment of Yale Global Tic Severity Scale (YGTSS) before randomization) on the Yale Global Tic Severity Scale Total Tic Score (YGTSS TTS). YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms.
Time Frame	From Randomization up to 12 weeks in Double-blind Randomized Withdrawal Phase

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) Sample included all participants who were randomized and received at least 1 dose of randomized investigational medicinal product (IMP) were included in this dataset and were analyzed according to the treatment group they were randomized to.

Arm/Group Title	Double Blind Phase: Aripiprazole Full Dose	Double Blind Phase: Aripiprazole Half Dose	Double Blind Phase: Placebo
Arm/Group Description	Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for <50 kg participants,and 10 mg or 20 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.	Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for <50 kg participants, and 5 mg or 10 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.	Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
Measure Participants	9	8	8
Number [percentage of participants]	0.0 0%	0.0 NaN	75.0 NaN

Adverse Events

Time Frame	From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Adverse Event Reporting Description	Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
Arm/Group Title	Open Label Stabilization Phase: Aripiprazole		Double Blind Phase: Aripiprazole Full Dose		Double Blind Phase: Aripiprazole Half Dose		Double Blind Phase: Placebo
Arm/Group Description	Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.		Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for <50 kg participants,and 10 mg or 20 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-blind Phase.		Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for <50 kg participants, and 5 mg or 10 mg for >50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.		Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
All Cause Mortality
	Open Label Stabilization Phase: Aripiprazole		Double Blind Phase: Aripiprazole Full Dose		Double Blind Phase: Aripiprazole Half Dose		Double Blind Phase: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Open Label Stabilization Phase: Aripiprazole		Double Blind Phase: Aripiprazole Full Dose		Double Blind Phase: Aripiprazole Half Dose		Double Blind Phase: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Psychiatric disorders
Suicidal Ideation	0/36 (0%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Open Label Stabilization Phase: Aripiprazole		Double Blind Phase: Aripiprazole Full Dose		Double Blind Phase: Aripiprazole Half Dose		Double Blind Phase: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/36 (47.2%)		3/9 (33.3%)		3/8 (37.5%)		2/8 (25%)
Cardiac disorders
Tachycardia	1/36 (2.8%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
General disorders
Fatigue	7/36 (19.4%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Infections and infestations
Pharyngitis streptococcal	0/36 (0%)		0/9 (0%)		1/8 (12.5%)		0/8 (0%)
Upper respiratory tract infection	1/36 (2.8%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Urinary tract infection	0/36 (0%)		0/9 (0%)		1/8 (12.5%)		0/8 (0%)
Injury, poisoning and procedural complications
Upper limb fracture	0/36 (0%)		0/9 (0%)		1/8 (12.5%)		0/8 (0%)
Investigations
Weight increased	3/36 (8.3%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Nervous system disorders
Somnolence	5/36 (13.9%)		0/9 (0%)		1/8 (12.5%)		0/8 (0%)
Headache	2/36 (5.6%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Sedation	4/36 (11.1%)		0/9 (0%)		0/8 (0%)		0/8 (0%)
Psychiatric disorders
Aggression	0/36 (0%)		0/9 (0%)		0/8 (0%)		1/8 (12.5%)
Enuresis	0/36 (0%)		1/9 (11.1%)		0/8 (0%)		0/8 (0%)
Irritability	1/36 (2.8%)		0/9 (0%)		0/8 (0%)		1/8 (12.5%)
Restlessness	1/36 (2.8%)		0/9 (0%)		0/8 (0%)		1/8 (12.5%)
Anxiety	2/36 (5.6%)		0/9 (0%)		0/8 (0%)		0/8 (0%)

Limitations/Caveats

This trial was terminated early due to the withdrawal of post-marketing commitment (PMC) to FDA. The planned interim analysis was not conducted either.

More Information

Certain Agreements

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

Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.