Restless Legs Syndrome Clinical Trial
— RLS-EcopipamOfficial title:
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
Verified date | July 2018 |
Source | The Methodist Hospital System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | October 15, 2018 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
William Ondo, MD | Restless Legs Syndrome Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hamilton depresion scale | scale | baseline to end of each treatment arm (6 weeks) | |
Other | MOS sleep scale | scale | baseline to end of each treatment arm (6 weeks) | |
Other | Fatigue severity scale | scale | baseline to end of each treatment arm (6 weeks) | |
Other | Columbia Suicide Severity Rating Scale | scale | baseline to end of each treatment arm (6 weeks) | |
Other | Epworth sleep scale | scale | baseline to end of each treatment arm (6 weeks) | |
Other | Serum chemistry (liver enzymes ALT and AST) | safety assessment | baseline to end of each treatment arm (6 weeks) | |
Other | Vital signs | safety assessment | baseline to end of each treatment arm (6 weeks) | |
Other | Physical/Neurological exam | safety assessment | baseline to end of each treatment arm (6 weeks) | |
Other | 12 lead ECG | safety assessment | baseline to end of each treatment arm (6 weeks) | |
Primary | International RLS Rating scale | scale | baseline to end of each treatment arm (6 weeks) | |
Primary | Augmentation severity scale | scale | baseline to end of each treatment arm (6 weeks) | |
Secondary | 24 hour RLS diary | diary of RLS symptoms | Day 0 (visit 1) to end of each treatment arm (6 weeks) | |
Secondary | Clinical Global Impression | scale | From start of each treatment arm through one week after treatment withdrawal |
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