Trial Outcomes & Findings for A First in Human Study of RT001 in Patients With Friedreich's Ataxia (NCT NCT02445794)
NCT ID: NCT02445794
Last Updated: 2020-11-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
28 days
Results posted on
2020-11-27
Participant Flow
Participant milestones
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
7
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A First in Human Study of RT001 in Patients With Friedreich's Ataxia
Baseline characteristics by cohort
| Measure |
Cohort 1 - RT001
n=6 Participants
RT001 - 2 capsules/day (1.8 g/day)
|
Cohort 1 - Comparator
n=3 Participants
RT001 comparator - 2 capsules/day
|
Cohort 2 - RT001
n=7 Participants
RT001 - 10 capsules/day (9 g/day)
|
Cohort 2 - Comparator
n=3 Participants
RT001 comparator - 10 capsules/day
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 2.08 • n=7 Participants
|
28.6 years
STANDARD_DEVIATION 7.46 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 4.16 • n=4 Participants
|
34.3 years
STANDARD_DEVIATION 9.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
22.82 kg/m^2
STANDARD_DEVIATION 3.857 • n=5 Participants
|
26.17 kg/m^2
STANDARD_DEVIATION 2.798 • n=7 Participants
|
21.63 kg/m^2
STANDARD_DEVIATION 3.096 • n=5 Participants
|
24.63 kg/m^2
STANDARD_DEVIATION 7.931 • n=4 Participants
|
23.47 kg/m^2
STANDARD_DEVIATION 4.128 • n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=3 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
n=7 Participants
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
n=3 Participants
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events
|
5 participants
|
2 participants
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 24 hoursAUC 0-24 hours post-dose (Hours -1.0 to -0.5 (pre-breakfast, pre-dose), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 2: 24 hours following dosing on Day 1 (± 30 min; pre-breakfast, pre-dose) was measured for the low and high dose cohorts after a single dose of RT001
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=7 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Pharmacokinetics - Area Under the Concentration-time Curve After a Single Dose
|
524 ug*h/mL
Standard Deviation 86
|
915 ug*h/mL
Standard Deviation 251
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPlasma levels were measured for the following time points: Day 1: Hours -1.0 to -0.5 (pre-breakfast, pre-dose), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 2: 24 hours following dosing on Day 1 (± 30 min; pre-breakfast, pre-dose) PK curves were constructed from these data and CMax measured on the curves for the low and high dose cohorts
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=7 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Pharmacokinetics - Maximum Observed Plasma Concentration After a Single Dose
|
35.9 ug/mL
Standard Deviation 9.8
|
58.6 ug/mL
Standard Deviation 16
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursTMax measured for the low and high dose cohorts
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=7 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Pharmacokinetics - Time to Reach Maximum Plasma Concentration After a Single Dose
|
6.05 h
Standard Deviation 0
|
8.0 h
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28-Day 31 (3 days)After 28 days of dosing, the final dose of RT001 was administered, and PK samples were obtained at the following timepoints (all timepoints refer to final dose on Day 28): Day 28: Hours -1.0 to -0.5 (pre-breakfast, pre-dose on Day 28), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 29: Hours 24 (± 30 min; pre-breakfast) and 32 (± 30 min) hours following final dose on Day 28 Day 30: 48 hours following final dose on Day 28 (± 30 min; pre-breakfast) Day 31: 72 hours following final dose on Day 28 (± 30 min; pre-breakfast) PK curves were constructed, and CMax at 28 days was determined from these curves
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=5 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Pharmacokinetics - Maximum Observed Plasma Concentration After Final Dose on Day 28
|
91 ug/mL
Standard Deviation 44.6
|
359.9 ug/mL
Standard Deviation 31.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28-Day 31 (3 days)After 28 days of dosing, the final dose of RT001 was administered, and PK samples were obtained at the following timepoints (all timepoints refer to final dose on Day 28): Day 28: Hours -1.0 to -0.5 (pre-breakfast, pre-dose on Day 28), 0.5 (± 5 min), 1 (± 5 min), 1.5 (± 5 min), 2 (± 10 min), 4 (± 10 min) (pre-lunch), 6 (± 10 min), 8 (± 10 min), 12 (± 10 min), and 16 (± 30 min) Day 29: Hours 24 (± 30 min; pre-breakfast) and 32 (± 30 min) hours following final dose on Day 28 Day 30: 48 hours following final dose on Day 28 (± 30 min; pre-breakfast) Day 31: 72 hours following final dose on Day 28 (± 30 min; pre-breakfast) PK curves were constructed, and T1/2 at 28 days was determined from these curves
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=5 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Pharmacokinetics - Terminal Half-life Estimation After Final Dose on Day 28
|
42.3 h
Standard Deviation 9.77
|
30.3 h
Standard Deviation 18.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 daysThe T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. T25FW was measured at baseline and at 28 days. These data were compared.
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=3 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
n=6 Participants
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
n=3 Participants
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Change From Baseline at 28 Days in the Timed 25 Foot Walk (T25FW)
|
.503 sec
Standard Deviation 3.7751
|
-1.87 sec
Standard Deviation 1.1653
|
-7.475 sec
Standard Deviation 28.6458
|
.608 sec
Standard Deviation 2.4182
|
SECONDARY outcome
Timeframe: 28 daysThe FARS-neurological rating scale specifically developed and validated for Friedreich's Ataxia. The FARS-Neurological included evaluations of the neurological signs that specifically reflect neural substrates affected in patients with FA. Based on a neurological examination bulbar (11 points), upper limb coordination (36 points), lower limb coordination (16 points), peripheral nervous system (26 points), and upright stability (36 points) functions were assessed for individual sub-scores (11, 36, 16, 26, and 36) with a maximum score of 125 (Friedreich's Ataxia Study Group, Subramony et al., 2005, Lynch et al., 2006). FARS-Neurologic examinations were conducted by a qualified physician or health professional trained in the use of the FARS format. A lower score is better. The minimum score is 0, the maximum score is 125.
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=3 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
n=7 Participants
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
n=3 Participants
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Change From Baseline at 28 Days in the Friedreich Ataxia Rating Scale (FARS) - Neurological Score (Minimum Score 0, Maximum Score 125, Lower is Better)
|
-6.22 units on a scale maximum 125
Standard Deviation 2.796
|
-6.47 units on a scale maximum 125
Standard Deviation 4.768
|
-3.3 units on a scale maximum 125
Standard Deviation 2.080
|
-2 units on a scale maximum 125
Standard Deviation 3.464
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects unable to start or complete the test were excluded from analysis. Treatment and comparator cohorts were pooled to allow for statistical analysis.
Peak workload was measured using cardiopulmonary exercise testing at baseline and after 28 days of treatment. The results of treatment were compared to baseline examination.
Outcome measures
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=10 Participants
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=6 Participants
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Change From Baseline at 28 Days in Peak Workload for the Treated Population vs. the Comparator Population
|
.08 watts/kg
Interval -0.1 to 0.34
|
-.08 watts/kg
Interval -0.3 to 0.0
|
—
|
—
|
Adverse Events
Cohort 1 - RT001 (1.8 g/Day)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1 - Comparator
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 - RT001 (9 g/Day)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2 - Comparator
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 participants at risk
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=3 participants at risk
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
n=7 participants at risk
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
n=3 participants at risk
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Steatorrhea requiring overnight hospitalization
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
Cohort 1 - RT001 (1.8 g/Day)
n=6 participants at risk
RT001, oral, 2 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 1 - Comparator
n=3 participants at risk
RT001 comparator, oral, 2 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
Cohort 2 - RT001 (9 g/Day)
n=7 participants at risk
RT001, oral, 10 capsules/day
RT001: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
|
Cohort 2 - Comparator
n=3 participants at risk
RT001 comparator, oral, 10 capsules/day
RT001 comparator: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
|
0.00%
0/3
|
57.1%
4/7 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/3
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/3
|
|
Infections and infestations
sinusitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/3
|
|
Nervous system disorders
dysgeusia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
facial fracture
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
muscle strain
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/3
|
|
Cardiac disorders
palpitations
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
Additional Information
Frederic Heerinckx/VP Clinical Operations
Retrotope, Inc
Phone: 650-437-0700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place