Augmentation, Restless Legs Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEcopipam
oral drug in subjection currently experiencing dopamine agonist induced augmentation
DRUGPlacebo
matching placebo
Sponsors
William Ondo, MD
Restless Legs Syndrome Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provide consent to participate in the study * Individuals of either sex, 21-80 years of age * Clinically defined Restless Leg Syndrome, and problematic augmentation currently on monotherapy with dopaminergic treatment.
Exclusion criteria
* Current use of Opioid medications * Clinical relevant depression or other medical problems that in the opinion of the investigator would not allow for safe completion of the protocol. * Suicidal ideation * History of epilepsy * Current MAO inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period | Baseline (Pre-intervention), and at 5 weeks | 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). |
| Change From Baseline in Mean Body Part Affected by RLS Symptoms Using Augmentation Severity Rating Scale (ASRS) | Baseline (Pre-intervention), and at 5 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24 Hour Restless Legs Syndrome (RLS) Diary at End of Intervention | at end of intervention Ecopipam, at end of intervention Placebo | 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) |
| Number of Participants With Effect on the Clinical Global Impression Scale at the End of the Intervention | At end of intervention Ecopipam, at end of intervention Placebo | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam G. Ondo, MD
The Methodist Hospital Research Institute
Participant flow
Recruitment details
10 Participants screened for eligibility between September 2017 through June 2018 at a hospital-associated specialty clinic in Houston, TX
Pre-assignment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 7.3 |
| Race/Ethnicity, Customized Caucasian | 10 participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 6 / 10 | 6 / 9 |
| serious Total, serious adverse events | 0 / 10 | 1 / 9 |
Outcome results
None listed