Cognitive Enhancement in Bipolar Disorder

• Sponsor: Northwell Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00597896
• Collaborator: Stanley Medical Research Institute (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 66
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be able to improve cognitive problems (i.e. difficulties with thinking, memory, and concentration) that may be associated with bipolar disorder.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: pramipexole	Phase 4

Detailed Description

To address the primary aim, the study is an eight-week, randomized, double-blind, placebo-controlled treatment trial of pramipexole in 50 euthymic bipolar I and II disorder (BPD) patients, who demonstrate cognitive impairment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cognitive Enhancement in Bipolar Disorder
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active pramipexole Day 1: Random assignment to drug or placebo and dosage starting at 0.125 mg BID, which will be increased every week to a target dose of 1.5 mg/day. Targeted maximum dose of 1.5 mg/day is expected to be reached by week 4, however, dosing will be flexible based upon side effects reported. The maximum dose will be 1.5 mg/day.	Drug: pramipexole; po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid; Other Names: Mirapex
Placebo Comparator: Placebo pramipexole Day 1: Random assignment to drug or placebo and dosage starting at 0.125 mg BID, which will be increased every week to a target dose of 1.5 mg/day. Targeted maximum dose of 1.5 mg/day is expected to be reached by week 4, however, dosing will be flexible based upon side effects reported. The maximum dose will be 1.5 mg/day.	Drug: pramipexole; po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid; Other Names: Mirapex

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward) [Change from Baseline to Week 8]

   The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

2. Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward) [Change from Baseline to Week 8]

   The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

3. Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test [Change from Baseline to Week 8]

   Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

4. Change From Baseline to Week 8 in Stroop Color-Word Test [Change from Baseline to Week 8]

   The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with 'Xs' printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

5. Change From Baseline to Week 8 in Trail Making Test Part A [Change from Baseline to Week 8]

   The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

6. Change From Baseline to Week 8 in Trail Making Test Part B [Change from Baseline to Week 8]

   The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

7. Change From Baseline to Week 8 in d2 Test of Attention [Change from Baseline to Week 8]

   The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the "d's" with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed.

8. Change From Baseline to Week 8 in Hopkins Verbal Learning Test [Change from Baseline to Week 8]

   The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

9. Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency [Change from Baseline to Week 8]

   The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.

Secondary Outcome Measures

1. Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint [Change from Baseline to Week 8]

   The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64.

2. Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint [Change from Baseline to Week 8]

   The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 ("Insight") which is rated on a 5-point Likert scale. These items yield two subscale scores-one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects between 18 and 65 years of age, who meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for BPD I or II (by SCID) and confirmed in the diagnostic consensus conference will be included.

• Subjects must also meet criteria for euthymia described above.

• All subjects must be taking a standard mood stabilizer at a stable therapeutic dose (i.e. lithium, carbamazepine, valproate, lamotrigine).

Exclusion Criteria:

• Subjects with a history of central nervous system (CNS) trauma, neurological disorder, Attention Deficit Hyperactivity Disorder (ADHD), or learning disability will be excluded.

• Subjects with a DSM-IV diagnosis of current or recent substance abuse or dependence (in the previous 1 month) will be excluded.

• Moreover, subjects with rapid-cycling during the past year will be excluded (based on SCID).

• Any subject with an active, unstable medical problem that may interfere with cognition will be excluded based on the investigator's judgment.

• While medication status is an important consideration in any study of bipolar disorder, the exclusion of patients taking any medication is not practical, given the high prevalence of combination pharmacotherapy for bipolar disorder. To help control for medication effects on cognition, we plan to limit the types of medications allowed by excluding certain medications with a known impact on cognitive performance.

• Subjects taking clozapine will be excluded due to it's potential overlapping mechanisms of action with pramipexole.

• Subjects taking prescription or over-the counter medications may also be excluded if these medications have been shown to impact cognition (i.e. diphenhydramine).

• The use of benzodiazepines, sedatives, or sleeping pills, within 6 hours of neurocognitive testing will not be allowed. In addition, patients taking topiramate, tricyclic antidepressants, or anticholinergic medications that are known to impact cognition will be excluded from participation.

• Subjects taking any medications that are known to interact with pramipexole (i.e. Zantac, Tagamet, Reglan, Benemid, Probalan, Compazine, Phenergan, quinidine, selegiline, verapamil, and any other medication with a known interaction) will also be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Shore - Long Island Jewish Health System	Glen Oaks	New York	United States	11004

Sponsors and Collaborators

• Northwell Health
• Stanley Medical Research Institute

Investigators

• Principal Investigator: Anil K. Malhotra, MD, Northwell Health
• Principal Investigator: Katherine Burdick, PhD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ray, Susan, Senior Research Coordinator, Northwell Health
• ClinicalTrials.gov Identifier: NCT00597896
• Other Study ID Numbers: 05-069; 05T-670
• First Posted: Jan 18, 2008
• Last Update Posted: Jun 12, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Bipolar Disorder; Pramipexole

Study Results

Participant Flow

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Period Title: Overall Study
STARTED	24	26
COMPLETED	21	24
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Active Pramipexole	Placebo Pramipexole	Total
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo	Total of all reporting groups
Overall Participants	21	24	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 100%	24 100%	45 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.81 (9.4)	44.42 (12.2)	44.14 (10.9)
Sex: Female, Male (Count of Participants)
Female	14 66.7%	10 41.7%	24 53.3%
Male	7 33.3%	14 58.3%	21 46.7%
Region of Enrollment (participants) [Number]
United States	21 100%	24 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)
Description	The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Baseline	8.43 (2.93)	8.54 (3.02)
Week 8	8.48 (2.40)	8.13 (2.52)
Change from Baseline to Week 8	.05 (1.72)	-.41 (2.08)

2. Secondary Outcome

Title	Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
Description	The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Mean (Standard Deviation) [units on a scale]	-.9 (5.5)	-1.5 (3.2)

3. Secondary Outcome

Title	Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint
Description	The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 ("Insight") which is rated on a 5-point Likert scale. These items yield two subscale scores-one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Mean (Standard Deviation) [units on a scale]	.5 (4.0)	-.9 (3.0)

4. Primary Outcome

Title	Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)
Description	The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Baseline	6.48 (2.09)	6.46 (2.48)
Week 8	6.86 (1.96)	6.67 (3.09)
Change from Baseline to Week 8	.38 (2.33)	.21 (1.35)

5. Primary Outcome

Title	Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test
Description	Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Baseline	8.52 (2.64)	8.08 (2.83)
Week 8	9.05 (3.46)	8.75 (3.07)
Change from Baseline to Week 8	.52 (2.23)	.67 (1.86)

6. Primary Outcome

Title	Change From Baseline to Week 8 in Stroop Color-Word Test
Description	The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with 'Xs' printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Word-Baseline	99.95 (18.20)	95.42 (13.16)
Word-Week 8	103.10 (16.09)	94.33 (14.40)
Word- Change from Baseline to Week 8	3.14 (12.46)	-1.08 (10.08)
Color- Baseline	68.10 (16.75)	66.54 (12.56)
Color-Week 8	72.24 (15.36)	66.29 (12.87)
Color- Change from Baseline to Week 8	4.14 (9.08)	-.25 (8.05)
Color-Word- Baseline	41.57 (9.93)	39.29 (9.43)
Color-Word-Week 8	43.95 (12.55)	40.08 (10.14)
Color-Word-Change from Baseline to Week 8	2.38 (8.96)	.79 (6.32)

7. Primary Outcome

Title	Change From Baseline to Week 8 in Trail Making Test Part A
Description	The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Baseline	32.88 (15.66)	35.37 (12.36)
Week 8	28.57 (12.05)	32.79 (13.99)
Change from Baseline to Week 8	-4.31 (8.23)	-2.58 (13.48)

8. Primary Outcome

Title	Change From Baseline to Week 8 in Trail Making Test Part B
Description	The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Baseline	76.90 (30.64)	106.14 (75.30)
Week 8	75.55 (34.52)	93.39 (73.09)
Change from Baseline to Week 8	-1.35 (28.48)	-12.74 (43.76)

9. Primary Outcome

Title	Change From Baseline to Week 8 in d2 Test of Attention
Description	The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the "d's" with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Mean (Standard Deviation) [units on a scale]	.90 (6.84)	1.54 (7.91)

10. Primary Outcome

Title	Change From Baseline to Week 8 in Hopkins Verbal Learning Test
Description	The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Baseline	8.00 (2.17)	8.13 (2.61)
Week 8	8.09 (2.86)	8.42 (2.34)
Change from Baseline to Week 8	.09 (2.55)	.29 (2.07)

11. Primary Outcome

Title	Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency
Description	The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Time Frame	Change from Baseline to Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants were assessed per protocol

Arm/Group Title	Active Pramipexole	Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID - pramipexole	0.125 mg BID-0.75 mg BID - matching placebo
Measure Participants	21	24
Baseline	38.33 (13.48)	33.63 (12.13)
Week 8	39.62 (14.30)	33.50 (10.49)
Change from Baseline to Week 8	1.29 (6.76)	-.13 (8.74)

Adverse Events

Arm/Group Title	Active Pramipexole		Placebo Pramipexole
Arm/Group Description	0.125 mg BID-0.75 mg BID pramipexole		0.125 mg BID-0.75 mg BID - matching placebo
All Cause Mortality
	Active Pramipexole		Placebo Pramipexole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Active Pramipexole		Placebo Pramipexole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		1/24 (4.2%)
General disorders
Car accident	1/21 (4.8%)		0/24 (0%)
Respiratory, thoracic and mediastinal disorders
Chest Pain	1/21 (4.8%)		1/24 (4.2%)
Other (Not Including Serious) Adverse Events
	Active Pramipexole		Placebo Pramipexole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.