Trial · NCT01244633
Ecopipam Treatment of Tourette Syndrome
NCT01244633, Phase 1, Phase 2, Completed, Psyadon Pharma; results first posted 2015-09-29
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Ecopipam Treatment of Tourette Syndrome. Trials, record NCT01244633. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01244633
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ecopipam Treatment of Tourette Syndrome
- NCT number
- NCT01244633
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Psyadon Pharma
- Conditions
- Tourette's Syndrome
- Interventions
- Ecopipam
- First posted
- 2010-11-19
- Last updated
- 2015-09-29
- Results first posted
- 2015-09-29
- Limitations and caveats
- This was an open label study with no placebo control
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Yale Global Tic Severity Score | 8 weeks | The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline. |
| Secondary | Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS) | Every 7 days | This is a standard measure of ADHD severity that is typically used in these types of clinical trials. |
| Secondary | Hamilton Depression Scale | Every 7 days | This is a measure of feelings of depression that the patient might have. |
| Secondary | Premonitory Urge for Tics Scale (PUTS-1) | Every 7 days | This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials. |
| Secondary | Clinician Global Impression - Improvement and Severity Scales (CGI) | End of trial | This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials. |
| Secondary | Safety Assessments | Every 7 days | Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur. |
| Secondary | Columbia Scale for Suicide Risk | Every 7 days | This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs. |
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 | Yale Global Tic Severity Score | 8 weeks | Subjects completing the study | units on a scale | MEAN |
| SECONDARY | Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS) | Every 7 days | |||
| SECONDARY | Hamilton Depression Scale | Every 7 days | |||
| SECONDARY | Premonitory Urge for Tics Scale (PUTS-1) | Every 7 days | |||
| SECONDARY | Clinician Global Impression - Improvement and Severity Scales (CGI) | End of trial | |||
| SECONDARY | Safety Assessments | Every 7 days | |||
| SECONDARY | Columbia Scale for Suicide Risk | Every 7 days |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Yale Global Tic Severity Score | Ecopipam | 25.3 | Standard Deviation 9.2 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ecopipam | 18 | |
| Overall Study | COMPLETED | Ecopipam | 15 | |
| Overall Study | NOT COMPLETED | Ecopipam | 3 |
Source ClinicalTrials.gov
Adverse events1
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 | Insomnia | Nervous system disorders | Ecopipam | 6 | 18 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ecopipam | ||
| Total, other adverse events | Ecopipam | 6 | 18 |
| Total, serious adverse events | Ecopipam | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 2905002 | 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 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/NCT01244633
GET https://conductscience.org/api/trials/v1/NCT01244633/registered