Trial · NCT00646451
Pregabalin in the Treatment of Essential Tremor
NCT00646451, Early phase 1, Completed, Baylor College of Medicine; results first posted 2021-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pregabalin in the Treatment of Essential Tremor. Trials, record NCT00646451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00646451
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin in the Treatment of Essential Tremor
- NCT number
- NCT00646451
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Essential Tremor
- Interventions
- pregabalin (Lyrica), placebo
- First posted
- 2008-03-28
- Last updated
- 2021-04-26
- Results first posted
- 2021-03-12
- Limitations and caveats
This is a investigator initiated trial that was completed in 2008 under 42 CFR 11.22 (b) and does not meet criteria. The study was a pilot and did not lead to registration nor to indication so this level of reporting is not be warranted.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Tremor Rating Scale (TRS) Compared With Baseline. | baseline to 6 weeks | Change from baseline in the overall TRS score obtained at the final evaluation (end of study). The overall TRS score will be derived from the three TRS subscales. The minimum and maximum score for part A is 0-80, part B is 0-36, and part C is 0-28 giving a maximum score of 144. TRS part A rates the severity of resting, postural and action tremor in upper and lower extremities, face, tongue, voice, head and trunk. Part B rates the severity of upper extremity tremor while writing, drawing, and pouring liquid. Part C rates functional disability of tremor while speaking, eating, drinking, maintaining hygiene, dressing, and working. Higher scores represent increased symptom severity or diminished quality of life. . |
| Secondary | Secondary Outcome Measures Quality of Life in Essential Tremor (QUEST), Hamilton Anxiety Scale (HAM-A), Hotel Dieu-16 a Sleep Hygiene Questionnaire(HD-16), and Clinical Clobal Impression-Change Scale (CGI-C) | baseline to 6 weeks | The Quality of Life in Essential Tremor Questionnaire (QUEST), Hamilton Anxiety scale (HAM-A) and Hotel Dieu-16 (HD-16) were scored as per published guidelines \[7\], \[8\] and \[9\]. The QUEST rates patient perception as influenced by tremor across 5 domains. A QUEST score will be between 0 and 120 with 0 = no essential tremor and 120 = severe essential tremor. The HAM-A rates the severity of anxiety symptomatology across 14 parameters. Scores of 14-17 = mild anxiety, 18-24 = moderate anxiety, and 25-30 = severe anxiety; The HD-16 rates insomnia-related quality of life across five domains. An HD-16 score of 73.1 - 248.5 = severe insomnia, 61-73.1 = mild insomnia, and 0 - 61 = good sleeper. For the scales, HAM-A, QUEST and HD-16, higher scores represent increased symptom severity or diminished quality of life. CGI-C was scored as follows: 1 = very much improved, 2=much improved, 3=mildly improved, 4=no change, 5=mildly worse, 6= much worse, and 7= very much worse. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Tremor Rating Scale (TRS) Compared With Baseline. | baseline to 6 weeks | Indistinguishable capsules and an identical titration protocol were used for PGB and placebo. Patients received the study drug at an initial dose of 75 mg twice daily, with upward titration to a target dose of 150 mg bid up to 300 mg bid. The study drug was increased at a rate of 150 mg/day/week. | units on a scale | MEAN |
| SECONDARY | Secondary Outcome Measures Quality of Life in Essential Tremor (QUEST), Hamilton Anxiety Scale (HAM-A), Hotel Dieu-16 a Sleep Hygiene Questionnaire(HD-16), and Clinical Clobal Impression-Change Scale (CGI-C) | baseline to 6 weeks | Change in secondary measures of efficacy compared with baseline. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 1-Pregabalin | TRS Part A | 2.4 | Standard Deviation 4.7 | units on a scale |
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 2-Placebo | TRS Part A | -0.2 | Standard Deviation 4.1 | units on a scale |
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 1-Pregabalin | TRS Part B | 6.7 | Standard Deviation 12.3 | units on a scale |
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 2-Placebo | TRS Part B | 3.6 | Standard Deviation 6.6 | units on a scale |
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 1-Pregabalin | TRS Part C | 4.5 | Standard Deviation 13.9 | units on a scale |
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 2-Placebo | TRS Part C | -1.5 | Standard Deviation 12.8 | units on a scale |
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 1-Pregabalin | Total TRS | 5.1 | Standard Deviation 9.7 | units on a scale |
| Change in Tremor Rating Scale (TRS) Compared With Baseline. | 2-Placebo | Total TRS | 0.3 | Standard Deviation 4.6 | units on a scale |
Secondary Outcome Measures Quality of Life in Essential Tremor (QUEST), Hamilton Anxiety Scale (HAM-A), Hotel Dieu-16 a Sleep Hygiene Questionnaire(HD-16), and Clinical Clobal Impression-Change Scale (CGI-C) | Pregabalin | QUEST | 8.0 | Standard Deviation 20.3 | units on a scale |
Secondary Outcome Measures Quality of Life in Essential Tremor (QUEST), Hamilton Anxiety Scale (HAM-A), Hotel Dieu-16 a Sleep Hygiene Questionnaire(HD-16), and Clinical Clobal Impression-Change Scale (CGI-C) | Placebo | QUEST | -9.7 | Standard Deviation 14.5 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin First, Then Placebo | 10 | |
| Overall Study | STARTED | Placebo First, Then Pregabalin | 10 | |
| Overall Study | COMPLETED | Pregabalin First, Then Placebo | 6 | |
| Overall Study | COMPLETED | Placebo First, Then Pregabalin | 10 | |
| Overall Study | NOT COMPLETED | Pregabalin First, Then Placebo | 4 | |
| Overall Study | NOT COMPLETED | Placebo First, Then Pregabalin | 0 |
Source ClinicalTrials.gov
Adverse events12
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 |
|---|---|---|---|---|---|---|
| other | drowsiness | General disorders | Pregabalin | 5 | 20 | 5 |
| other | drowsiness | General disorders | Placebo | 3 | 18 | 3 |
| other | dizziness | General disorders | Pregabalin | 4 | 20 | 4 |
| other | dizziness | General disorders | Placebo | 1 | 18 | 1 |
| other | fatigue | General disorders | Pregabalin | 3 | 20 | 3 |
| other | fatigue | General disorders | Placebo | 0 | 18 | 0 |
| other | instability | General disorders | Pregabalin | 3 | 20 | 3 |
| other | instability | General disorders | Placebo | 1 | 18 | 1 |
| other | insomnia | General disorders | Pregabalin | 0 | 20 | 0 |
| other | insomnia | General disorders | Placebo | 2 | 18 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 14 | 20 |
| Total, other adverse events | Placebo | 9 | 18 |
| Total, serious adverse events | Pregabalin | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19631949 | BACKGROUND |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00646451
GET https://conductscience.org/api/trials/v1/NCT00646451/registered