The Effect of Horizant (Gabapentin Enacarbil) on Augmentation

• Status: Completed
• Trial end date: 2019-05-06
• Target enrollment: 0
• Participant gender: All

Summary

Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main complication during long-term DA treatment of RLS. This study aims to examine effect of Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Dopamine; Dopamine Agents; Dopamine Agonists; Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

1. Adult patients with diagnosis of RLS for more than one year.

2. Patients who are on DA therapy for 6 months or longer.

3. Patients who developed Augmentation (on stable dose of DA) lasting for 3 months or longer.

4. Augmentation severity rating scale of 5 to 15.

5. Both males and females

6. Age range = 18-85 year

Exclusion Criteria:

• Known Hypersensitivity to Horizant or Gabapentin products

• Peripheral neuropathy

• Radiculopathy

• Peripheral vascular disease

• Uremia [abnormal blood urea nitrogen (BUN) or Creatinine on Comprehensive Metabolic Panel (CMP)]

• Anemia

• Patients who are currently pregnant

• Patients who currently take opioids, lithium, anti-nausea medications (e.g. metoclopramide), dopaminergic antagonists (e.g. Haloperidol), 1st generation antihistamines (e.g. diphenhydramine, pseudoephedrine), anti-psychotic medications and iron therapy.

• Subjects with impaired decision making capability.