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Trial record 52 of 186 for:    GLYCOPYRROLATE

Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587079
Recruitment Status : Completed
First Posted : April 27, 2012
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: PT003
Drug: PT001
Drug: PT005
Drug: Tiotropium inhalation powder
Enrollment 159
Recruitment Details The study was conducted at 20 sites in the US from May 2012 until September 2012. The entire study was scheduled to take a maximum of 19 weeks for each individual subject.
Pre-assignment Details Study was a chronic dosing (7 days), 4-period, 8-treatment, Incomplete Block, Cross-Over.
Arm/Group Title All Subjects
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 159
Completed 120
Not Completed 39
Reason Not Completed
Protocol-specified criteria             9
Protocol Violation             5
Lost to Follow-up             2
Physician Decision             2
Withdrawal by Subject             7
Adverse Event             14
Arm/Group Title All Subjects Screened
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 159
Hide Baseline Analysis Population Description
ITT/Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age, years Number Analyzed 159 participants
62.8  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants
Female
76
  47.8%
Male
83
  52.2%
1.Primary Outcome
Title FEV1 AUC 0-12 on Day 7
Hide Description FEV1 AUC 0-12
Time Frame Day 7
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MITT
Arm/Group Title GP MDI 18 μg (PT001) GFF MDI 18/9.6 μg (PT003) GFF/MDI 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI 2.4/9.6 μg (PT003) GFF MDI 1.2/9.6 μg (PT003) FF MDI 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
18 μg
18/9.6 μg
9/9.6 μg
4.6/9.6 μg
2.4/9.6 μg
1.2/9.6 μg
9.6 μg
18 μg QD
Overall Number of Participants Analyzed 57 59 52 57 57 60 57 60
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.452
(1.415 to 1.489)
1.591
(1.554 to 1.628)
1.547
(1.509 to 1.585)
1.539
(1.502 to 1.575)
1.538
(1.502 to 1.575)
1.508
(1.472 to 1.545)
1.467
(1.430 to 1.505)
1.489
(1.453 to 1.525)
2.Secondary Outcome
Title Peak Change From Baseline in FEV1 on Treatment Day 1
Hide Description Peak change from Baseline in FEV1 on Treatment
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 59 63 56 60 60 64 59 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Milliliters
209
(172 to 246)
339
(302 to 376)
329
(292 to 367)
348
(311 to 386)
333
(296 to 370)
312
(275 to 349)
317
(280 to 355)
238
(201 to 274)
3.Secondary Outcome
Title Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Hide Description Time to onset of action (>10% improvement in FEV1)
Time Frame Day 1
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MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 60 62 55 58 60 64 60 62
Measure Type: Number
Unit of Measure: Percentage
15 minutes 27 65 51 62 65 66 60 37
30 minutes 8 18 13 10 10 9 3 21
1 hour 15 6 11 12 12 5 12 11
2 hours 10 5 7 5 2 9 3 5
No onset within 2 hours 40 6 18 10 12 11 22 26
4.Secondary Outcome
Title Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
Hide Description Proportion of subjects achieving >=12% improvement in FEV1
Time Frame Day 1
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MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg GP MDI 18 μg (PT001)
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg
Overall Number of Participants Analyzed 60 63 55 59 61 65 61 63
Measure Type: Number
Unit of Measure: Percentage
56 93 85 84 86 83 80 72
5.Secondary Outcome
Title Peak Change From Baseline in Inspiratory Capacity on Day 1
Hide Description Peak change from baseline in Inspiratory Capacity
Time Frame Day 1
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MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 60 63 56 61 61 65 62 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Milliliters
204
(131 to 278)
393
(320 to 467)
320
(244 to 397)
387
(313 to 461)
347
(274 to 421)
348
(276 to 420)
335
(261 to 409)
233
(160 to 305)
6.Secondary Outcome
Title Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
Hide Description Change from baseline in morning pre-dose trough FEV1
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 60 62 56 61 60 65 60 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Milliliters
120
(87 to 152)
183
(151 to 216)
150
(117 to 184)
154
(121 to 186)
163
(130 to 195)
130
(98 to 162)
104
(71 to 137)
122
(90 to 155)
7.Secondary Outcome
Title Peak Change From Baseline in FEV1 on Day 7
Hide Description Peak change from baseline in FEV1 Day 7
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 60 63 55 60 61 64 60 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millliters
300
(257 to 342)
444
(402 to 487)
414
(370 to 458)
403
(361 to 446)
388
(345 to 430)
363
(321 to 404)
332
(289 to 375)
309
(267 to 351)
8.Secondary Outcome
Title Change From Baseline in Morning Pre-dose Trough IC on Day 7
Hide Description Change from baseline in morning pre-dose trough IC
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 60 63 56 61 61 63 62 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millliters
109
(46 to 171)
185
(123 to 246)
183
(119 to 247)
215
(153 to 278)
203
(141 to 265)
151
(89 to 212)
129
(67 to 191)
106
(45 to 168)
9.Secondary Outcome
Title Peak Change From Baseline IC on Day 7
Hide Description Peak change from baseline IC
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 60 63 56 61 61 65 62 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millliters
223
(149 to 297)
430
(357 to 503)
441
(366 to 516)
409
(335 to 484)
368
(294 to 441)
371
(298 to 444)
377
(303 to 452)
241
(168 to 314)
10.Secondary Outcome
Title Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
Hide Description Change from baseline at evening 12-hour post-dose trough FEV1
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI BID 18 μg GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI BID 1.2/9.6 μg FF MDI BID 9.6 μg Spiriva 18 μg QD
Hide Arm/Group Description:
BID 18 μg
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
BID 1.2/9.6 μg
BID 9.6 μg
18 μg QD
Overall Number of Participants Analyzed 57 61 53 59 57 61 59 61
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Millliters
99
(53 to 145)
196
(151 to 241)
162
(115 to 209)
118
(73 to 163)
133
(87 to 179)
110
(65 to 155)
73
(28 to 119)
130
(85 to 174)
11.Secondary Outcome
Title Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
Hide Description Change from baseline in mean morning pre-dose daily peak flow readings
Time Frame Day 7
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Hide Analysis Population Description
MITT
Arm/Group Title GP MDI 18 μg BID GFF MDI 18/9.6 μg BID GFF/MDI 9/9.6 μg BID GFF MDI BID 4.6/9.6 μg GFF MDI 2.4/9.6 μg BID GFF MDI 1.2/9.6 μg BID FF MDI 9.6 μg BID Spiriva 18 μg QD
Hide Arm/Group Description:
18 μg BID
18/9.6 μg BID
9/9.6 μg BID
4.6/9.6 μg
2.4/9.6 μg BID
1.2/9.6 μg BID
9.6 μg BID
18 μg QD
Overall Number of Participants Analyzed 59 63 56 61 61 64 62 62
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/min
7.6
(0.5 to 14.8)
25.2
(18.1 to 32.4)
16.6
(9.4 to 23.9)
12.4
(5.2 to 19.5)
18.0
(10.9 to 25.1)
13.8
(6.7 to 20.8)
8.6
(1.5 to 15.7)
11.6
(4.5 to 18.7)
12.Secondary Outcome
Title Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
Hide Description Change from baseline in mean morning post-dose daily peak flow readings on
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI 18 μg BID GFF MDI BID 18/9.6 μg GFF/MDI BID 9/9.6 μg GFF MDI BID 4.6/9.6 μg GFF MDI BID 2.4/9.6 μg GFF MDI 1.2/9.6 μg BID FF MDI 9.6 μg BID Spiriva 18 μg QD
Hide Arm/Group Description:
18 μg BID
BID 18/9.6 μg
BID 9/9.6 μg
4.6/9.6 μg
BID 2.4/9.6 μg
1.2/9.6 μg BID
9.6 μg BID
18 μg QD
Overall Number of Participants Analyzed 59 62 56 61 61 64 62 62
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/min
31.0
(23.0 to 39.0)
58.8
(50.9 to 66.7)
55.0
(46.9 to 63.1)
46.7
(38.8 to 54.6)
52.1
(44.1 to 60.0)
49.6
(41.7 to 57.4)
43.2
(35.3 to 51.1)
37.9
(30.0 to 45.8)
13.Secondary Outcome
Title Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
Hide Description Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI 18 μg BID GFF MDI 18/9.6 μg BID GFF/MDI 9/9.6 μg BID GFF MDI 4.6/9.6 μg BID GFF MDI 2.4/9.6 μg BID GFF MDI 1.2/9.6 μg BID FF MDI 9.6 μg BID Spiriva18 μg QD
Hide Arm/Group Description:
18 μg BID
18/9.6 μg BID
9/9.6 μg BID
4.6/9.6 μg BID
2.4/9.6 μg BID
1.2/9.6 μg BID
9.6 μg BID
18 μg QD
Overall Number of Participants Analyzed 57 59 56 58 60 63 62 0
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/min
11.7
(4.6 to 18.7)
32.5
(25.4 to 39.5)
25.0
(18.0 to 32.1)
19.0
(12.0 to 26.0)
25.6
(18.7 to 32.5)
19.9
(13.0 to 26.8)
16.5
(9.6 to 23.4)
14.Secondary Outcome
Title Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
Hide Description Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title GP MDI 18 μg BID GFF MDI 18/9.6 μg BID GFF/MDI 9/9.6 μg BID GFF MDI BID 4.6/9.6 μg BID GFF MDI 2.4/9.6 μg BID GFF MDI 1.2/9.6 μg BID FF MDI 9.6 μg BID Spiriva 18 μg QD
Hide Arm/Group Description:
18 μg BID
18/9.6 μg BID
9/9.6 μg BID
4.6/9.6 μg BID
2.4/9.6 μg BID
1.2/9.6 μg BID
9.6 μg BID
18 μg QD
Overall Number of Participants Analyzed 57 57 56 58 60 63 62 60
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/min
35.0
(26.8 to 43.2)
61.5
(53.1 to 69.8)
56.1
(47.8 to 64.3)
51.5
(43.3 to 59.7)
53.7
(45.6 to 61.7)
53.8
(45.8 to 61.8)
48.3
(40.3 to 56.4)
30.3
(22.2 to 38.4)
Time Frame SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.
Adverse Event Reporting Description Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.
 
Arm/Group Title GP MDI 18 μg (PT001) GFF MDI 18/9.6 μg (PT003) GFF MDI 9/9.6 μg (PT003) GFF MDI 4.6/9.6 μg (PT003) GFF MDI 2.4/9.6 μg (PT003) GFF MDI 1.2/9.6 μg (PT003) FF MDI 9.6 μg (PT005) Spiriva
Hide Arm/Group Description 18 μg 18/9.6 μg 9/9.6 μg 4.6/9.6 μg 2.4/9.6 μg 1.2/9.6 μg 9.6 μg 18 μg
All-Cause Mortality
GP MDI 18 μg (PT001) GFF MDI 18/9.6 μg (PT003) GFF MDI 9/9.6 μg (PT003) GFF MDI 4.6/9.6 μg (PT003) GFF MDI 2.4/9.6 μg (PT003) GFF MDI 1.2/9.6 μg (PT003) FF MDI 9.6 μg (PT005) Spiriva
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GP MDI 18 μg (PT001) GFF MDI 18/9.6 μg (PT003) GFF MDI 9/9.6 μg (PT003) GFF MDI 4.6/9.6 μg (PT003) GFF MDI 2.4/9.6 μg (PT003) GFF MDI 1.2/9.6 μg (PT003) FF MDI 9.6 μg (PT005) Spiriva
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/66 (1.52%)      1/71 (1.41%)      0/70 (0.00%)      0/67 (0.00%)      1/71 (1.41%)      2/68 (2.94%)      1/73 (1.37%)      0/71 (0.00%)    
Cardiac disorders                 
Cardio-Respiratory arrest  1  0/66 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 1/68 (1.47%)  1 0/73 (0.00%)  0 0/71 (0.00%)  0
Tachycardia  1  0/66 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 1/68 (1.47%)  1 0/73 (0.00%)  0 0/71 (0.00%)  0
General disorders                 
Sudden Death  1  0/66 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 0/68 (0.00%)  0 1/73 (1.37%)  1 0/71 (0.00%)  0
Injury, poisoning and procedural complications                 
Spinal Compression fracture  1  0/66 (0.00%)  0 0/71 (0.00%)  0 0/70 (0.00%)  0 0/67 (0.00%)  0 1/71 (1.41%)  1 0/68 (0.00%)  0 0/73 (0.00%)  0 0/71 (0.00%)  0
Nervous system disorders                 
Transient Ischaemic attack  1  0/66 (0.00%)  0 1/71 (1.41%)  1 0/70 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 0/68 (0.00%)  0 0/73 (0.00%)  0 0/71 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Pneumothorax  1  1/66 (1.52%)  1 0/71 (0.00%)  0 0/70 (0.00%)  0 0/67 (0.00%)  0 0/71 (0.00%)  0 0/68 (0.00%)  0 0/73 (0.00%)  0 0/71 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GP MDI 18 μg (PT001) GFF MDI 18/9.6 μg (PT003) GFF MDI 9/9.6 μg (PT003) GFF MDI 4.6/9.6 μg (PT003) GFF MDI 2.4/9.6 μg (PT003) GFF MDI 1.2/9.6 μg (PT003) FF MDI 9.6 μg (PT005) Spiriva
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/66 (12.12%)      2/71 (2.82%)      8/70 (11.43%)      5/67 (7.46%)      9/71 (12.68%)      2/68 (2.94%)      8/73 (10.96%)      6/71 (8.45%)    
Gastrointestinal disorders                 
Dry Mouth  1  8/66 (12.12%)  8 2/71 (2.82%)  2 3/70 (4.29%)  3 3/67 (4.48%)  3 5/71 (7.04%)  5 1/68 (1.47%)  1 6/73 (8.22%)  8 6/71 (8.45%)  6
Nervous system disorders                 
Tremor  1  0/66 (0.00%)  0 0/71 (0.00%)  0 5/70 (7.14%)  5 2/67 (2.99%)  2 4/71 (5.63%)  4 1/68 (1.47%)  1 2/73 (2.74%)  2 0/71 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Colin Resiner, MD, FCCP, FAAAAI
Organization: Pearl Therapeutics, Inc
Phone: 973-975-0320
EMail: creisner@pearltherapeutics.com
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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01587079     History of Changes
Other Study ID Numbers: PT003005
First Submitted: April 25, 2012
First Posted: April 27, 2012
Results First Submitted: May 23, 2016
Results First Posted: June 30, 2016
Last Update Posted: June 30, 2016