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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.
This is an Open label single arm study. The purpose of the study is to demonstrate the efficacy of Horizant in patients with RLS who exhibit augmentation while on Dopaminergic therapy. Adult patients (age 18-85 years) with diagnosis of primary RLS (diagnosed by study investigators) with augmentation on dopaminergic therapy will be screened for participation in the study. RLS diagnosis will be made by the study investigators using International RLS study group criteria. Patients with augmentation on dopaminergic therapy as defined by NIH 2007 with ASRS of 5 to 15 will be offered to participate in the study. Inclusion and exclusion criteria are listed below. The study will be performed after approval of the Institutional Review Board of the University of Missouri.
A total of 50 subjects will be entered into the study over a period of 1 year. Written consent will be obtained from all patients. After pre-participation evaluation for eligibility, subjects will be selected and enrolled in the study and followed for a total of 6 follow up visits (Days 0, 30, 90, 120, 180, 360). Subjects Enrollment period will last up to 12 months. The total duration of study will be 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label | Other | open-label single arm study Horizant, 600 mg oral once daily at 5 pm for 360 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Horizant | Drug | Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I. Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Augmentation Severity From Day 0 to Day 90 | Augmentation severity rating scale; 0-24, 0 is better, 24 is worst | From Day 0 (Baseline) to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication) | Numeric Scale to assess degree of augmentation; Range 0-24; 0 is better, 24 is worst. We compared the Augmentation severity scale on day 0 to day 360 (which is 270 days after this decrease of dopaminergic medication) | Day 0 to day 360 (270 days after discontinuing dopaminergic medication) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pradeep Sahota, MD | University of Missouri Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label | open-label single arm study Horizant, 600 mg oral once daily at 5 pm for 360 days. Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I. Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects:
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label | open-label single arm study Horizant, 600 mg oral once daily at 5 pm for 360 days. Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I. Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 in Augmentation Severity From Day 0 to Day 90 | Augmentation severity rating scale; 0-24, 0 is better, 24 is worst | 10 patients enrolled - 2 dropped out - 8 completed the study | Posted | Median | Full Range | score on a scale | From Day 0 (Baseline) to Day 90 |
|
1 year and 7 months
Standard adverse event definition used
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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 | Open-label | open-label single arm study Horizant, 600 mg oral once daily at 5 pm for 360 days. Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I. Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meralgia paraesthetica | Nervous system disorders | Systematic Assessment | Meralgia paraesthetica |
Limited (small numbers) open label study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pradeep Sahota MD | University of Missouri Columbia | 573-882-6402 | sahotap@missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2017 | Nov 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2017 | Dec 14, 2021 | SAP_001.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 |
|---|---|
| D000077206 | Gabapentin |
| C493250 | 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| IRLS score | Higher International Restless Leg Syndrome - Rating Scale score means worse disease than lower score (Scale ranges from 1-40) | Median | Full Range | units on a scale |
|
| Augmentation Severity rating scale | Augmentation Severity Rating Scale: Higher number suggests worse disease than lower score (0-24) | Median | Full Range | units on a scale |
|
|
|
|
| Secondary | Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication) | Numeric Scale to assess degree of augmentation; Range 0-24; 0 is better, 24 is worst. We compared the Augmentation severity scale on day 0 to day 360 (which is 270 days after this decrease of dopaminergic medication) | Only 8 subjects completed the study to its final point | Posted | Median | Full Range | score on a scale | Day 0 to day 360 (270 days after discontinuing dopaminergic medication) |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rheumatoid arthritis - exacerbation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sleep apnea | Nervous system disorders | Systematic Assessment |
|
| Calcification on right thyroid gland | Endocrine disorders | Systematic Assessment |
|
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |