History of a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS.
Serum ferritin level < 20 ng/mL at screening.
History of allergy, hypersensitivity, or intolerance to HORIZANT or any other gabapentin products (eg, Neurontin®, Gralise®).
Suffering from a movement disorder that could mimic or confound the accurate diagnosis of RLS (eg, Tourette's syndrome, tic disorder, periodic limb movement disorder [PLMD], sleep disorders).
Currently meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for substance use disorder, or history thereof, within 12 months before dosing.
Current or past history of any significant psychiatric disorder including, but not limited to, depression (treatment with antidepressants), bipolar disorder, or schizophrenia.
Diagnosis of attention-deficit hyperactivity disorder (ADHD) is allowed, provided the patient is not receiving medication(s) known to affect the assessment of RLS.
History of suicidal behavior or suicidal ideation as indicated by the C-SSRS, administered at screening (the questionnaire is provided in Appendix 4), and as per investigator's judgment.
History of seizure disorder or at increased risk for development of a seizure disorder including, but not limited to, complicated febrile seizure and history of significant head injury.
Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of gabapentin enacarbil, or, in the investigator's judgment is considered to be clinically significant and may pose a safety concern, or, could interfere with the accurate assessment of safety or efficacy, or could potentially affect a patient's safety or study outcome.
Clinically significant abnormal laboratory result or physical examination finding not resolved by the time of baseline assessments.

NCT02560766_exc_T1
Condition
primary sleep disorder
NCT02560766_exc_T2
Negation
other
NCT02560766_exc_T3
Condition
RLS
NCT02560766_exc_T4
Measurement
Serum ferritin
NCT02560766_exc_T5
Value
< 20 ng/mL
NCT02560766_exc_T6
Condition
allergy
NCT02560766_exc_T7
Condition
hypersensitivity
NCT02560766_exc_T8
Condition
intolerance
NCT02560766_exc_T9
Scope
allergy, hypersensitivity, or intolerance
NCT02560766_exc_T10
Drug
HORIZANT
NCT02560766_exc_T11
Drug
gabapentin
NCT02560766_exc_T12
Drug
Neurontin
NCT02560766_exc_T13
Drug
Gralise
NCT02560766_exc_T14
Scope
Neurontin®, Gralise®
NCT02560766_exc_T15
Scope
HORIZANT or any other gabapentin products (eg, Neurontin®, Gralise®
NCT02560766_exc_T16
Condition
movement disorder
NCT02560766_exc_T17
Condition
Tourette's syndrome
NCT02560766_exc_T18
Condition
tic disorder
NCT02560766_exc_T19
Condition
periodic limb movement disorder
NCT02560766_exc_T20
Condition
PLMD
NCT02560766_exc_T21
Condition
sleep disorders
NCT02560766_exc_T22
Scope
Tourette's syndrome, tic disorder, periodic limb movement disorder [PLMD], sleep disorders
NCT02560766_exc_T23
Condition
substance use disorder
NCT02560766_exc_T24
Temporal
within 12 months
NCT02560766_exc_T25
Measurement
Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition
NCT02560766_exc_T26
Measurement
DSM-5
NCT02560766_exc_T27
Condition
psychiatric disorder
NCT02560766_exc_T28
Qualifier
significant
NCT02560766_exc_T29
Condition
depression
NCT02560766_exc_T30
Drug
antidepressants
NCT02560766_exc_T31
Condition
bipolar disorder
NCT02560766_exc_T32
Condition
schizophrenia
NCT02560766_exc_T33
Scope
depression (treatment with antidepressants), bipolar disorder, or schizophrenia
NCT02560766_exc_T34
Condition
attention-deficit hyperactivity disorder
NCT02560766_exc_T35
Condition
ADHD
NCT02560766_exc_T36
Negation
allowed
NCT02560766_exc_T37
Observation
suicidal behavior
NCT02560766_exc_T38
Condition
suicidal ideation
NCT02560766_exc_T39
Condition
seizure disorder
NCT02560766_exc_T40
Condition
complicated febrile seizure
NCT02560766_exc_T41
Condition
head injury
NCT02560766_exc_T42
Scope
complicated febrile seizure and history of significant head injury