Trial · NCT00681863
Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
NCT00681863, Phase 3, Terminated, Boehringer Ingelheim; results first posted 2010-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome. Trials, record NCT00681863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00681863
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
- NCT number
- NCT00681863
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 45 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Tourette Syndrome
- Interventions
- pramipexole 0.125 mg BID, pramipexole 0.0625 mg QD, pramipexole 0.125 mg TID, pramipexole 0.25 mg BID, pramipexole 0.0625 mg BID
- First posted
- 2008-05-21
- Last updated
- 2014-05-23
- Other registries' IDs
- eudract:2008-000342-32
- Results first posted
- 2010-12-17
- Limitations and caveats
The sponsor cancelled this trial prematurely. Thus, enrollment for 248.642 (NCT00681863) was significantly less than what was planned (120 planned vs. 45 entered). Therefore, the objectives of this study could not be fully assessed.
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With Adverse Events Leading to Discontinuation of Trial Drug | 24 Weeks | Number of patients with Adverse Events leading to discontinuation of trial drug |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and week 24 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
| Secondary | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | baseline and Week 24 (end of treatment visit) | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 1 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 2 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 3 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and week 4 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 8 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 12 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
| Secondary | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 16 | Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and week 24 | The Full Analysis Set (FAS) with last observation carried forward (LOCF). | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | baseline and Week 24 (end of treatment visit) | The Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 1 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 2 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 3 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and week 4 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 8 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 12 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 16 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and Week 20 | Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint. | Score on a scale | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -9.8 | Standard Deviation 8.9 | Score on a scale | |
| Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | Pramipexole | -22.0 | Standard Deviation 21.0 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -7.2 | Standard Deviation 8.5 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -8.3 | Standard Deviation 7.7 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -8.6 | Standard Deviation 8.6 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -9.3 | Standard Deviation 9.7 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -10.7 | Standard Deviation 9.4 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -12.3 | Standard Deviation 9.0 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -12.4 | Standard Deviation 9.3 | Score on a scale | |
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | Pramipexole | -11.7 | Standard Deviation 11.3 | Score on a scale |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pramipexole | 45 | |
| Overall Study | COMPLETED | Pramipexole | 22 | |
| Overall Study | NOT COMPLETED | Pramipexole | 23 |
Source ClinicalTrials.gov
Adverse events19
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 | Abdominal pain upper | Gastrointestinal disorders | Pramipexole | 4 | 45 | |
| other | Nausea | Gastrointestinal disorders | Pramipexole | 8 | 45 | |
| other | Vomiting | Gastrointestinal disorders | Pramipexole | 4 | 45 | |
| other | Fatigue | General disorders | Pramipexole | 6 | 45 | |
| other | Pyrexia | General disorders | Pramipexole | 4 | 45 | |
| other | Hypersensitivity | Immune system disorders | Pramipexole | 4 | 45 | |
| other | Nasopharyngitis | Infections and infestations | Pramipexole | 5 | 45 | |
| other | Upper respiratory tract infection | Infections and infestations | Pramipexole | 4 | 45 | |
| other | Skin laceration | Injury, poisoning and procedural complications | Pramipexole | 3 | 45 | |
| other | Increased appetite | Metabolism and nutrition disorders | Pramipexole | 4 | 45 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pramipexole | ||
| Total, other adverse events | Pramipexole | 35 | 45 |
| Total, serious adverse events | Pramipexole | 1 | 45 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00681863
GET https://conductscience.org/api/trials/v1/NCT00681863/registered?page=2