Trial Outcomes & Findings for Peripheral Dopamine in Postural Tachycardia Syndrome (NCT NCT00685919)
NCT ID: NCT00685919
Last Updated: 2022-01-24
Results Overview
Urine was collected for 24hr during treatment. Urinary volume was measured and the urine was analyzed for sodium and creatinine concentrations. Total amounts of sodium and creatinine excreted over the 24 hr were calculated and results expressed as ratio of sodium:creatinine.
COMPLETED
PHASE2/PHASE3
32 participants
Immediately before the 1st dose of placebo or carbidopa to immediately before the 5th dose (approximately 24 hours)
2022-01-24
Participant Flow
* Healthy Participants Group: 21 healthy controls enrolled. 3 withdrew prior to randomization. 1 screen failed. 17 healthy participants were randomized. 1 participant was withdrawn due to orthostatic symptoms during baseline testing * Postural Tachycardia Syndrome (POTS) Group: 11 POTS participants were randomized. 1 participant withdrew after the 1st dose of the intervention (placebo).
Participant milestones
| Measure |
Healthy Participants-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
|
Healthy Participants-Carbidopa Then Placebo
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
|
Patients With POTS-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
|
Patients With POTS-Carbidopa Then Placebo
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
3
|
|
Overall Study
Baseline A
|
8
|
9
|
8
|
3
|
|
Overall Study
Treatment A
|
7
|
9
|
8
|
3
|
|
Overall Study
24 hr Post-treatment A
|
7
|
9
|
7
|
3
|
|
Overall Study
Baseline B
|
7
|
9
|
7
|
3
|
|
Overall Study
Treatment B
|
7
|
9
|
7
|
3
|
|
Overall Study
24 hr Post Treatment B
|
7
|
9
|
7
|
3
|
|
Overall Study
COMPLETED
|
7
|
9
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Healthy Participants-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
|
Healthy Participants-Carbidopa Then Placebo
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
|
Patients With POTS-Placebo Then Carbidopa
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
|
Patients With POTS-Carbidopa Then Placebo
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Peripheral Dopamine in Postural Tachycardia Syndrome
Baseline characteristics by cohort
| Measure |
Healthy Participants-Placebo Then Carbidopa
n=8 Participants
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
|
Healthy Participants-Carbidopa Then Placebo
n=8 Participants
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
|
Patients With POTS-Placebo Then Carbidopa
n=7 Participants
Placebo every 6 hours for 5 doses followed by Carbidopa 200 mg every 6 hours orally for 5 doses
|
POTS-Carbidopa Then Placebo
n=3 Participants
Carbidopa 200 mg every 6 hours for 5 doses followed by Placebo given orally every 6 hours for 5 doses
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 11 • n=5 Participants
|
32 years
STANDARD_DEVIATION 10 • n=7 Participants
|
31 years
STANDARD_DEVIATION 10 • n=5 Participants
|
37 years
STANDARD_DEVIATION 3 • n=4 Participants
|
32.8 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
26 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Immediately before the 1st dose of placebo or carbidopa to immediately before the 5th dose (approximately 24 hours)Population: No data analysis for the following: Healthy Placebo Group: * 1 subject with discarded urine sample * 1 subject who received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose) POTS Placebo Group: * 1 subject with discarded urine sample * 1 subject who received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose)
Urine was collected for 24hr during treatment. Urinary volume was measured and the urine was analyzed for sodium and creatinine concentrations. Total amounts of sodium and creatinine excreted over the 24 hr were calculated and results expressed as ratio of sodium:creatinine.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=14 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=15 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=8 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
24 Hour Urinary Sodium Excretion During Treatment Normalized to Creatinine
|
140 Milliequivalents per gram (mEq/g)
Standard Deviation 29
|
132 Milliequivalents per gram (mEq/g)
Standard Deviation 38
|
137 Milliequivalents per gram (mEq/g)
Standard Deviation 30
|
154 Milliequivalents per gram (mEq/g)
Standard Deviation 31
|
SECONDARY outcome
Timeframe: 8 hours after the last dose of placebo or carbidopaPopulation: No data analysis for the following: Healthy Placebo Group: * 1 subject with missing systolic blood pressure 8-hours after the last dose of Placebo * 1 subject who received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose) POTS Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose)
Systolic blood pressure was measured once using a Dinamap non-invasive oscillometric blood pressure monitor, 2-4 hours after lunch and after at least 30 minutes of resting supine.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=14 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=15 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=9 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
Systolic Blood Pressure Measured at 8 Hours After the Last Dose of Placebo or Carbidopa
|
103 millimeters of mercury (mmHg)
Standard Deviation 4
|
101 millimeters of mercury (mmHg)
Standard Deviation 8
|
102 millimeters of mercury (mmHg)
Standard Deviation 9
|
101 millimeters of mercury (mmHg)
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 8 hours after the last dose of placebo or carbidopaPopulation: No data analysis for the following: Healthy Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose) POTS Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose)
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=15 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=15 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=9 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
Plasma Catecholamines (Norepinephrine) After the Last Dose of Placebo or Carbidopa
|
150 Picograms per milliliter (pg/mL)
Standard Deviation 46
|
181 Picograms per milliliter (pg/mL)
Standard Deviation 100
|
278 Picograms per milliliter (pg/mL)
Standard Deviation 84
|
245 Picograms per milliliter (pg/mL)
Standard Deviation 70
|
SECONDARY outcome
Timeframe: 8 hours after the last dose of placebo or carbidopaPopulation: No data analysis for the following: Healthy Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose) POTS Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose)
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. For catecholamine measurements, blood was collected in chilled vacuum tubes with EDTA. Plasma was separated and stored with added reduced glutathione (Amersham International PLC) at -70°C until the assay. Plasma catecholamines were measured by a method that involves batch alumina extraction followed by high-performance liquid chromatography (HPLC) for separation with electrochemical detection and quantification.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=15 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=15 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=9 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
Plasma Catecholamines (DOPA) After the Last Dose of Placebo or Carbidopa
|
1813 Picograms per milliliter (pg/mL)
Standard Deviation 463
|
20297 Picograms per milliliter (pg/mL)
Standard Deviation 9509
|
2104 Picograms per milliliter (pg/mL)
Standard Deviation 700
|
25680 Picograms per milliliter (pg/mL)
Standard Deviation 13825
|
SECONDARY outcome
Timeframe: Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)Population: No data analysis for the following participants: Healthy Placebo: * 1 w/ discarded urine sample * 1 w/ urine not analyzed for catecholamines * 1 received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa: * 1 w/ urine not analyzed for catecholamines * 1 received only 50mg carbidopa (wrong dose) POTS Placebo: * 1 w/ discarded urine sample * 1 received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa: * 1 received only 50mg carbidopa (wrong dose)
Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=13 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=14 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=8 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
24 Hour Urinary Catecholamine (DOPA) Excretion During Treatment Normalized to Creatinine
|
0.024 Micrograms per milligrams (ug/mg)
Standard Deviation 0.014
|
0.283 Micrograms per milligrams (ug/mg)
Standard Deviation 0.194
|
0.026 Micrograms per milligrams (ug/mg)
Standard Deviation 0.015
|
0.385 Micrograms per milligrams (ug/mg)
Standard Deviation 0.156
|
SECONDARY outcome
Timeframe: Immediately before the 1st dose of Placebo or Carbidopa and ending immediately before the last dose (approximately 24 hours)Population: No data analysis for the following participants: Healthy Placebo: * 1 w/ discarded urine sample * 1 w/ urine not analyzed for catecholamines * 1 received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa: * 1 w/ urine not analyzed for catecholamines * 1 received only 50mg carbidopa (wrong dose) POTS Placebo: * 1 w/ discarded urine sample * 1 received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa: * 1 received only 50mg carbidopa (wrong dose)
Urine was collected over 24 hours during treatment. The urinary volume was measured and the urine was analyzed for creatinine and catecholamines. Total amounts of creatinine and catecholamines were calculated and the results are expressed as catecholamine:creatinine.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=13 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=14 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=8 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
24 Hour Urinary Catecholamine (Dopamine) Excretion During Treatment Normalized to Creatinine
|
0.208 Micrograms per milligrams (ug/mg)
Standard Deviation 0.061
|
0.035 Micrograms per milligrams (ug/mg)
Standard Deviation 0.015
|
0.24 Micrograms per milligrams (ug/mg)
Standard Deviation 0.081
|
0.038 Micrograms per milligrams (ug/mg)
Standard Deviation 0.015
|
SECONDARY outcome
Timeframe: 2 hours after the last dose of placebo or carbidopaPopulation: No data analysis for the following: Healthy Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose) POTS Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose)
Blood samples were collected while resting supine for at least 30 minutes and 1 1/2 to 2 hours after breakfast. Samples were processed and sent to the Vanderbilt Clinic Laboratory for assay.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=15 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=15 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=9 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
Supine Plasma Renin Activity 2 Hours After the Last Dose of Placebo or Carbidopa
|
1.153 Nanograms per milliliter per hour (ng/mL
Standard Deviation 0.926
|
1.033 Nanograms per milliliter per hour (ng/mL
Standard Deviation 0.529
|
1.544 Nanograms per milliliter per hour (ng/mL
Standard Deviation 1.02
|
1.878 Nanograms per milliliter per hour (ng/mL
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 8 hours after the last dose of placebo or carbidopaPopulation: No data analysis for the following: Healthy Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) Healthy Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose) POTS Placebo Group: * 1 subject who received only 50mg carbidopa (data for all arms excluded) POTS Carbidopa Group: * 1 subject who received only 50mg carbidopa (wrong dose)
Blood samples were collected while resting supine for at least 30 minutes and 2 to 4 hours after lunch. Samples were processed and sent to the Vanderbilt Clinical Laboratory for assay.
Outcome measures
| Measure |
Healthy Participants Who Received Placebo as Treatment A or Treatment B
n=15 Participants
Healthy participants received Placebo matching Carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants Who Received Carbidopa as Treatment A or Treatment B
n=15 Participants
Healthy participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
Postural Tachycardia Syndrome (POTS) Participants Who Received Placebo as Treatment A or Treatment B
n=9 Participants
POTS participants received Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Postural Tachycardia Syndrome (POTS) Patients Who Received Carbidopa as Treatment A or Treatment B
n=9 Participants
POTS participants received Carbidopa: 200 mg every 6 hours for 5 doses given orally
|
|---|---|---|---|---|
|
Plasma Sodium After the Last Dose of Placebo or Carbidopa
|
138 Milliequivalents per liter (mEq/L)
Standard Deviation 1.9
|
138 Milliequivalents per liter (mEq/L)
Standard Deviation 1.9
|
139 Milliequivalents per liter (mEq/L)
Standard Deviation 2.2
|
138 Milliequivalents per liter (mEq/L)
Standard Deviation 2
|
Adverse Events
Healthy Participants-Placebo
Healthy Participants-Carbidopa
POTS Participants-Placebo
POTS Participants-Carbidopa
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Participants-Placebo
n=17 participants at risk
Placebo matching carbidopa given every 6 hours orally for 5 doses
|
Healthy Participants-Carbidopa
n=17 participants at risk
Carbidopa 200 mg every 6 hours orally for 5 doses
|
POTS Participants-Placebo
n=11 participants at risk
Placebo matching carbidopa given every 6 hours orally for 5 doses
|
POTS Participants-Carbidopa
n=11 participants at risk
Carbidopa 200 mg every 6 hours orally for 5 doses
|
|---|---|---|---|---|
|
Nervous system disorders
Head rush
|
0.00%
0/17 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/17 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
9.1%
1/11 • Number of events 1 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/11 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/17 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
5.9%
1/17 • Number of events 1 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/11 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/11 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/17 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/17 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
9.1%
1/11 • Number of events 1 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/11 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/17 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/11 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/11 • Participants were followed for 24 hours after the 5th dose of treatment.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
Additional Information
Alfredo Gamboa, MD
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place