Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Restless Leg Syndrome, Neurology |
| Therapuetic Areas: | Neurology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 7/26/2018 |
| Start Date: | September 18, 2017 |
| End Date: | October 15, 2018 |
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.
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.
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.
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
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