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| Name | Class |
|---|---|
| Restless Legs Syndrome Foundation | UNKNOWN |
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This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat patients currently having dopamine agonist induced augmentation in restless legs syndrome. Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week wash-out period. Efficacy points will include the IRLS, augmentation scales, sleep scales, clinical impressions and fatigue/mood scales.
This is a double-blind, exploratory proof of concept, cross-over trial of the D1 antagonist ecopipam for subjects with augmented Restless legs syndrome (RLS). Investigators will recruit 10 subjects taking dopamine agonists for RLS who are currently experiencing augmentation. The goal is to have 8 completers. There is no power analysis as this is an exploratory study and there is no previous data on treatment of augmentation. "Meaningful improvement" is not even established. A safety analysis will be done after 5 subjects have been enrolled. Duration of study and is based mostly on contracted drug availability for this pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study period 1 | Experimental |
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| Study period 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecopipam | Drug | oral drug in subjection currently experiencing dopamine agonist induced augmentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period | IRLS scale is a patient-administered test that measures the severity of restless legs syndrome symptoms. The IRLS scale consists of 10 questions rated from 0 to 4. The total score on symptom severity range from 0 (none) to 40 (worst). | Baseline (Pre-intervention), and at 5 weeks |
| Change From Baseline in Mean Body Part Affected by RLS Symptoms Using Augmentation Severity Rating Scale (ASRS) | ASRS scale has three items and probes symptoms over the past week. The first item asks the time at which symptoms began in the last week. The second item probes how quickly symptoms begin when sitting at various times of the day during the past week, and the third item probes which body parts were involved in the past week. Each item has a total of 8 points for a 24-point total scale. 0 is no augmentation and 24 is the most severe augmentation. In the third item, participants are asked to shade in the figure the portions of his/her body affected by RLS symptoms for a total of 8 points. The higher the score the worse the outcome | Baseline (Pre-intervention), and at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24 Hour Restless Legs Syndrome (RLS) Diary at End of Intervention | Patient reported diary of RLS symptoms 72 hours prior to clinic visit. Participants were asked to record the number of hours each day they were bothered by RLS symptoms and when symptoms were present but not bothersome. The range can be 0 (no symptoms) to 72 (uniterupted symptoms) | at end of intervention Ecopipam, at end of intervention Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean From Baseline Epworth Sleep Scale (ESS) at the End of the Intervention | The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G. Ondo, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
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This is a double-blind, exploratory proof of concept, cross over trial where a two week washout period separating group interventions (ecopipam first, then placebo) and (placebo first, then ecopipam)
10 of 10 participants were randomized. Of those randomized, 1 was lost to follow-up
10 Participants screened for eligibility between September 2017 through June 2018 at a hospital-associated specialty clinic in Houston, TX
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| ID | Title | Description |
|---|---|---|
| FG000 | Ecopipam First, Then Placebo | Participants received Ecopipam 25mg by mouth for 7 days (week 1), followed by Ecopipam 50mg by mouth for 7 days (week 2), followed by Ecopipam 100mg by mouth for 23 days. After a wash-out period of 2 weeks, they then received Placebo 25mg by mouth for 7 days (week 1), followed by Placebo 50mg by mouth for 7 days (week 2), followed by Placebo 100mg by mouth for 23 days. |
| FG001 | Placebo First, Then Ecopipam | Participants received Placebo 25mg by mouth for 7 days (week 1), followed by Placebo 50mg by mouth for 7 days (week 2), followed by Placebo 100mg by mouth for 23 days. After a wash-out period of 2 weeks, they then received Ecopipam 25mg by mouth for 7 days (week 1), followed by Ecopipam 50mg by mouth for 7 days (week 2), followed by Ecopipam 100mg by mouth for 23 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (5 weeks) |
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| Washout (2 weeks) |
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| Second Intervention (5 weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Baseline characteristics of all study participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period | IRLS scale is a patient-administered test that measures the severity of restless legs syndrome symptoms. The IRLS scale consists of 10 questions rated from 0 to 4. The total score on symptom severity range from 0 (none) to 40 (worst). | All participants who received at least one dose of each intervention were included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-intervention), and at 5 weeks |
|
5 weeks for each interevention
Safety population included all participants who received at least one dose of intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ecopipam | Participants who received Ecopipam 25-100mg in either the first arm or the second arm of the cross-over trial |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | unrelated respiratory infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sedation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Ondo, MD | Methodist Neurological Institute | 713-363-8484 | wondo@houstonmethodist.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2017 | Dec 6, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C058081 | ecopipam |
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placebo
| Placebo | Drug | matching placebo |
|
| Number of Participants With Effect on the Clinical Global Impression Scale at the End of the Intervention | A Modified clinician-administered scale used to evaluate the effect of an intervention on participant symptoms. Responses range from None/worse, mild, Marked or very marked. | At end of intervention Ecopipam, at end of intervention Placebo |
| Baseline (Pre-intervention), and at Week 5 |
| Change in Mean Score From Baseline Montreal Cognitive Assessment (MoCA) at End of Intervention | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Score range from 0 - 30 with lower scores reflecting worse outcomes. | Baseline (Pre-intervention), and at Week 5 |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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Participants who received placebo tablet (matching Ecopipam 25-100mg) in either the first arm or the second arm of the cross-over trial |
|
|
| Primary | Change From Baseline in Mean Body Part Affected by RLS Symptoms Using Augmentation Severity Rating Scale (ASRS) | ASRS scale has three items and probes symptoms over the past week. The first item asks the time at which symptoms began in the last week. The second item probes how quickly symptoms begin when sitting at various times of the day during the past week, and the third item probes which body parts were involved in the past week. Each item has a total of 8 points for a 24-point total scale. 0 is no augmentation and 24 is the most severe augmentation. In the third item, participants are asked to shade in the figure the portions of his/her body affected by RLS symptoms for a total of 8 points. The higher the score the worse the outcome | All participants who received at least one dose of each intervention were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-intervention), and at 5 weeks |
|
|
|
| Secondary | Mean 24 Hour Restless Legs Syndrome (RLS) Diary at End of Intervention | Patient reported diary of RLS symptoms 72 hours prior to clinic visit. Participants were asked to record the number of hours each day they were bothered by RLS symptoms and when symptoms were present but not bothersome. The range can be 0 (no symptoms) to 72 (uniterupted symptoms) | All participants who received at least one dose of each intervention were included in the analysis. At end of intervention (Week 5), the total number of hours of RLS symptoms experience (whether mild or bothersome) was recorded 72 hours prior to clinic visit. | Posted | Mean | Full Range | hours | at end of intervention Ecopipam, at end of intervention Placebo |
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| Secondary | Number of Participants With Effect on the Clinical Global Impression Scale at the End of the Intervention | A Modified clinician-administered scale used to evaluate the effect of an intervention on participant symptoms. Responses range from None/worse, mild, Marked or very marked. | All participants who received at least one dose of each intervention were included in the analysis | Posted | Count of Participants | Participants | At end of intervention Ecopipam, at end of intervention Placebo |
|
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| Other Pre-specified | Change in Mean From Baseline Epworth Sleep Scale (ESS) at the End of the Intervention | The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. | All participants who received at least one dose of each intervention were included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-intervention), and at Week 5 |
|
|
|
| Other Pre-specified | Change in Mean Score From Baseline Montreal Cognitive Assessment (MoCA) at End of Intervention | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Score range from 0 - 30 with lower scores reflecting worse outcomes. | All participants who received at least one dose of each intervention were included in the analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre-intervention), and at Week 5 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Placebo | Participants who received Placebo (Matching Ecopipam 25-100mg) in either the first arm or the second arm of the cross-over trial | 0 | 9 | 1 | 9 | 6 | 9 |
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| Dry mouth | Endocrine disorders | Systematic Assessment |
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| Fatigue | Nervous system disorders | Systematic Assessment |
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| Elevated glucose | Endocrine disorders | Systematic Assessment |
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| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Breast Pain | Reproductive system and breast disorders | Systematic Assessment |
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| Generalized muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shingles | Infections and infestations | Systematic Assessment |
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| Generalized stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Poison Ivy rash | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| Mild on CGI |
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| None/Worse on CGI |
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