Trial Outcomes & Findings for A Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease (NCT NCT00214500)
NCT ID: NCT00214500
Last Updated: 2018-10-30
Results Overview
TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 96 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Day 1 (after dosing) through Week 96
Results posted on
2018-10-30
Participant Flow
Participant milestones
| Measure |
Migalastat
Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 milligrams (mg) twice a day (BID) for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).
Extension Period:
* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg once a day (QD) for Weeks 48 through 96.
|
|---|---|
|
Treatment Period
STARTED
|
9
|
|
Treatment Period
Safety Population
|
9
|
|
Treatment Period
Pharmacokinetic (PK) Population
|
9
|
|
Treatment Period
Pharmacodynamic (PD) Population
|
9
|
|
Treatment Period
COMPLETED
|
8
|
|
Treatment Period
NOT COMPLETED
|
1
|
|
Extension Period
STARTED
|
8
|
|
Extension Period
COMPLETED
|
6
|
|
Extension Period
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Migalastat
Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 milligrams (mg) twice a day (BID) for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).
Extension Period:
* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg once a day (QD) for Weeks 48 through 96.
|
|---|---|
|
Treatment Period
Adverse Event
|
1
|
|
Extension Period
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Baseline characteristics by cohort
| Measure |
Migalastat
n=9 Participants
Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).
Extension Period:
* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg QD for Weeks 48 through 96.
|
|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Age, Customized
17 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
18 to 55 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
58 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after dosing) through Week 96Population: Safety Population: all eligible-enrolled participants who received at least 1 dose of study drug. 6 participants were dosed screen failures, and were not included in the safety analysis.
TEAEs were defined as any adverse event with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe adverse event was defined as an adverse event that was incapacitating and required medical intervention. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through Week 96 is presented. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Migalastat
n=9 Participants
Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).
Extension Period:
* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg QD for Weeks 48 through 96.
|
Migalastat 100 mg
Migalastat was administered orally. Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
|
Migalastat 250 mg
Migalastat was administered orally. Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
|
|---|---|---|---|
|
Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, and 10 hr (postdose)Population: PK Population: all eligible-enrolled participants who received study drug and had at least 1 postbaseline PK parameter recorded. One participant discontinued prior to receiving doses of migalastat 100 and 250 mg.
The AUC from time zero to 12 hours (hr) postdose (AUC0-12) was evaluated in plasma following a single dose of migalastat 25, 100, and 250 mg on Days 1, 15, and 29, respectively. In addition, AUC0-12 was assessed following multiple doses (14 days) of migalastat 25, 100, and 250 mg on Days 14, 28, and 42, respectively.
Outcome measures
| Measure |
Migalastat
n=9 Participants
Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).
Extension Period:
* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg QD for Weeks 48 through 96.
|
Migalastat 100 mg
n=8 Participants
Migalastat was administered orally. Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
|
Migalastat 250 mg
n=8 Participants
Migalastat was administered orally. Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
|
|---|---|---|---|
|
PK: Area Under The Concentration Versus Time Curve (AUC) After Administration Of Migalastat
AUC0-12: Single Dose
|
1052.96 nanograms*hr/milliliters (ng*hr/mL)
Geometric Coefficient of Variation 29.9
|
4217.95 nanograms*hr/milliliters (ng*hr/mL)
Geometric Coefficient of Variation 32.0
|
10880.66 nanograms*hr/milliliters (ng*hr/mL)
Geometric Coefficient of Variation 32.4
|
|
PK: Area Under The Concentration Versus Time Curve (AUC) After Administration Of Migalastat
AUC0-12: Multiple Dose
|
1360.69 nanograms*hr/milliliters (ng*hr/mL)
Geometric Coefficient of Variation 32.9
|
5643.50 nanograms*hr/milliliters (ng*hr/mL)
Geometric Coefficient of Variation 25.3
|
12244.47 nanograms*hr/milliliters (ng*hr/mL)
Geometric Coefficient of Variation 26.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12 (end of treatment period), Week 96 (end of extension period)Population: PD Population: all eligible-enrolled participants who received at least 1 dose of study drug on Day 1, and who had a non-missing baseline and at least 1 non-missing postbaseline PD parameter recorded. Participants who discontinued prior to the specified time point were not analyzed because no data were available.
Leukocytes were isolated from whole blood and lysed, and α-Gal A activity was measured using a validated fluorometric assay, with catalysis to fluorescent 4-methylumbelliferone (4-MU) as the activity measure. The activity values obtained were normalized to protein (measured using a colorimetric assay) and reported as enzyme activity (nanomole \[nmol\] 4-MU/hr) per mg of protein. On Day 1 of the first visit and at every visit thereafter, the samples were collected prior to dosing with migalastat. α-Gal A activity in leukocytes are presented by individual participants.
Outcome measures
| Measure |
Migalastat
n=9 Participants
Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).
Extension Period:
* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg QD for Weeks 48 through 96.
|
Migalastat 100 mg
Migalastat was administered orally. Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
|
Migalastat 250 mg
Migalastat was administered orally. Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
|
|---|---|---|---|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 1: Baseline
|
5.2 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 1: Week 12
|
17.4 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 1: Week 96
|
20.3 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 2: Baseline
|
4.7 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 2: Week 12
|
24.6 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 2: Week 96
|
22.8 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 3: Baseline
|
6.6 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 3: Week 12
|
24.6 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 3: Week 96
|
20.3 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 4: Baseline
|
1.0 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 4: Week 12
|
14.8 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 4: Week 96
|
12.8 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 5: Baseline
|
10.7 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 6: Baseline
|
0.9 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 6: Week 12
|
3.9 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 6: Week 96
|
1.9 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 7: Baseline
|
0.0 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 7: Week 12
|
0.4 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 8: Baseline
|
0.1 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 8: Week 12
|
0.9 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 9: Baseline
|
0.2 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 9: Week 12
|
0.3 nmol 4-MU/hr/mg protein
|
—
|
—
|
|
α-Galactosidase A (α-Gal A) Activity In Leukocytes At Baseline, Week 12, And Week 96
Participant 9: Week 96
|
0.2 nmol 4-MU/hr/mg protein
|
—
|
—
|
Adverse Events
Migalastat
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Migalastat
n=9 participants at risk
Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on Day 28).
* Migalastat 250 mg BID for Weeks 5 and 6 (Day 29 through the morning dose on Day 42).
* Migalastat 25 mg BID for Weeks 6 to 12 (Days 43 to 84).
Extension Period:
* Migalastat 25 mg BID for Weeks 12 through 48.
* Migalastat 50 mg QD for Weeks 48 through 96.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Skin and subcutaneous tissue disorders
Angiokeratoma
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Cardiac disorders
Arrhythmia
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Psychiatric disorders
Bipolar disorder
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Investigations
Blood creatine phosphokinase increased
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Investigations
Blood glucose increased
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Ear and labyrinth disorders
Deafness
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Renal and urinary disorders
Dysuria
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
General disorders
Fatigue
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Infections and infestations
Giardiasis
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Gingival pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Nervous system disorders
Headache
|
55.6%
5/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
General disorders
Hunger
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
General disorders
Influenza like illness
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Psychiatric disorders
Libido decreased
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Renal and urinary disorders
Micturition urgency
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Odynophagia
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
General disorders
Pain
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Infections and infestations
Respiratory tract infection
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract irritation
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
General disorders
Thirst
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Infections and infestations
Tinea versicolour
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Day 1 after dosing through Week 96 (end of extension period)
|
|
Ear and labyrinth disorders
Vertigo
|
22.2%
2/9 • Day 1 after dosing through Week 96 (end of extension period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator can only publish the results from this trial provided they supply the sponsor (or authorized entity) a copy of any proposed publication for review. If requested, the investigator will remove information deemed confidential or proprietary by the sponsor and will withhold publication for an additional period of time to allow the sponsor to take appropriate measures to establish and preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER