Trial · NCT00547911
Augmenting Effects of L-DOPS With Carbidopa and Entacapone
NCT00547911, Phase 1, Phase 2, Terminated, National Institute of Neurological Disorders and Stroke (NINDS); results first posted 2014-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Augmenting Effects of L-DOPS With Carbidopa and Entacapone. Trials, record NCT00547911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00547911
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Augmenting Effects of L-DOPS With Carbidopa and Entacapone
- NCT number
- NCT00547911
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Conditions
- Parkinson Disease, Multiple System Atrophy, Autonomic Nervous System Diseases
- Interventions
- Droxidopa, Carbidopa, Entacapone
- First posted
- 2007-10-23
- Last updated
- 2014-07-17
- Results first posted
- 2014-07-17
- Limitations and caveats
Study was prematurely terminated due to a small amount of DOPAL contamination in the droxidopa. Because of the early termination only a small number of subjects were enrolled in each condition. Recently, the FDA has approved droxidopa.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations. |
| Primary | Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma norepinephrine concentrations. |
| Primary | Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxymandelic acid (DHMA) concentrations. |
| Primary | Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma dihydroxyphenylglycol (DHPG) concentrations. |
| Secondary | Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 24 hours after receiving drug(s) | Systolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours. |
| Secondary | Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 24 hours after receiving drug(s) | Diastolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours. |
| Secondary | Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 24 hours after receiving drug(s) | Heart rate was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the Limitations and Caveats section. In addition, some subject data was unable to be analyzed due to unreliable measurements. | nmol/L | MEAN |
| PRIMARY | Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the Limitations and Caveats section. In addition, some subject data was unable to be analyzed due to unreliable measurements. | nmol/L | MEAN |
| PRIMARY | Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the Limitations and Caveats section. In addition, some subject data was unable to be analyzed due to unreliable measurements. | nmol/L | MEAN |
| PRIMARY | Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 48 hours after receiving drug(s) | Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the Limitations and Caveats section. In addition, some subject data was unable to be analyzed due to unreliable measurements. | nmol/L | MEAN |
| SECONDARY | Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 24 hours after receiving drug(s) | Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the Limitations and Caveats section. In addition, some subject data was unable to be analyzed due to unreliable measurements. | mmHg | MEAN |
| SECONDARY | Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 24 hours after receiving drug(s) | Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the Limitations and Caveats section. In addition, some subject data was unable to be analyzed due to unreliable measurements. | mmHg | MEAN |
| SECONDARY | Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | Up to 24 hours after receiving drug(s) | Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the Limitations and Caveats section. In addition, some subject data was unable to be analyzed due to unreliable measurements. | BPM | MEAN |
Source ClinicalTrials.gov
Results by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + Placebo | Baseline | 0 | Standard Error 0 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + CAR | Baseline | 0.003 | Standard Error 0.003 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + ENT | Baseline | 0.897 | Standard Error 0.753 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + Placebo | 1 Hour | 2246 | Standard Error 611 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + CAR | 1 Hour | 1731 | Standard Error 440 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + ENT | 1 Hour | 2068 | Standard Error 413 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + Placebo | 2 Hour | 7067 | Standard Error 1955 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + CAR | 2 Hour | 7077 | Standard Error 1324 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + ENT | 2 Hour | 9114 | Standard Error 1962 | nmol/L |
| Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone | LDOPS + Placebo | 3 Hour | 8695 | Standard Error 1659 | nmol/L |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT | 2 | |
| Overall Study | STARTED | LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR | 2 | |
| Overall Study | STARTED | LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT | 2 | |
| Overall Study | STARTED | LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo | 2 | |
| Overall Study | STARTED | LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR | 3 | |
| Overall Study | STARTED | LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo | 3 | |
| Overall Study | COMPLETED | LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT | 2 | |
| Overall Study | COMPLETED | LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR | 2 | |
| Overall Study | COMPLETED | LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT | 2 | |
| Overall Study | COMPLETED | LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Deep Vein Thrombosis followed by Pulmonary Embolism | Blood and lymphatic system disorders | LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT | 0 | 2 | |
| serious | Deep Vein Thrombosis followed by Pulmonary Embolism | Blood and lymphatic system disorders | LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR | 0 | 2 | |
| serious | Deep Vein Thrombosis followed by Pulmonary Embolism | Blood and lymphatic system disorders | LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT | 0 | 2 | |
| serious | Deep Vein Thrombosis followed by Pulmonary Embolism | Blood and lymphatic system disorders | LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo | 1 | 2 | |
| serious | Deep Vein Thrombosis followed by Pulmonary Embolism | Blood and lymphatic system disorders | LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR | 0 | 3 | |
| serious | Deep Vein Thrombosis followed by Pulmonary Embolism | Blood and lymphatic system disorders | LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo | 0 | 3 |
Source ClinicalTrials.gov
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT | ||
| Total, all-cause mortality | LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR | ||
| Total, all-cause mortality | LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT | ||
| Total, all-cause mortality | LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo | ||
| Total, all-cause mortality | LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR | ||
| Total, all-cause mortality | LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo | ||
| Total, other adverse events | LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT | 0 | 2 |
| Total, other adverse events | LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR | 0 | 2 |
| Total, other adverse events | LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT | 0 | 2 |
| Total, other adverse events | LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo | 0 | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00547911
GET https://conductscience.org/api/trials/v1/NCT00547911/results?page=2