24 completed, 3 unknown, 1 withdrawn. 13 Phase 2, 6 Phase 1, 6 Phase 3, 4 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 13 |
| Phase 1 | 6 | Completed 5, Withdrawn 1 |
| Phase 3 | 6 | Completed 6 |
| Phase 4 | 4 | Unknown 3, Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS HORIZANT 300 mg, HORIZANT 600 mg, Placebo - RLS | Phase 4 | Unknown | XenoPort, Inc. | 132 | 2016-02-01 | 2021-06-09 |
| An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS HORIZANT 600 mg - RLS | Phase 4 | Unknown | XenoPort, Inc. | 144 | 2016-01-01 | 2021-06-09 |
| A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS HORIZANT 300 mg - RLS | Phase 1 | Withdrawn | XenoPort, Inc. | 2016-01-01 | 2021-04-12 | |
| Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome Gabapentin Enacarbil (GEn), Placebo - Restless Legs Syndrome | Phase 4 | Unknown | Cleveland Sleep Research Center | 20 | 2015-06-01 | 2015-04-23 |
| A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis XP23829 400 mg QD, XP 23829 800 mg QD, XP23829 400 mg BID - Psoriasis | Phase 2 | Completed | Dr. Reddy's Laboratories Limited | 200 | 2014-06-01 | 2022-04-12 |
| Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study GSK1838262 600 mg, GSK1838262 450 mg, GSK1838262 300 mg - Restless Legs Syndrome | Phase 4 | Completed | XenoPort, Inc. | 501 | 2012-06-01 | 2021-05-24 |
| A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers GEn 1200mg, Gen 6000 mg, GEn Placebo - Restless Legs Syndrome | Phase 1 | Completed | XenoPort, Inc. | 52 | 2012-01-01 | 2021-04-12 |
| Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine morphine Placebo, GEn 600 mg, Morphine - Restless Legs Syndrome | Phase 1 | Completed | XenoPort, Inc. | 18 | 2011-08-01 | 2013-07-16 |
| Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects gabapentin enacarbil, diphenhydramine, placebo - Restless Legs Syndrome (RLS) | Phase 1 | Completed | XenoPort, Inc. | 36 | 2011-06-01 | 2013-07-16 |
| Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis Arbaclofen placarbil 15 mg BID, Placebo, Arbaclofen placarbil 30 mg BID - Multiple Sclerosis | Phase 3 | Completed | XenoPort, Inc. | 228 | 2011-05-01 | 2021-02-21 |
| A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects XP21279 and carbidopa (experimental), Sinemet (comparator), Placebo for XP21279 and carbidopa - Parkinson's Disease | Phase 2 | Completed | XenoPort, Inc. | 35 | 2010-07-01 | 2021-02-18 |
| A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) arbaclofen placarbil-Cohort 1, Placebo-Cohort 5, arbaclofen placarbil-Cohort 2 - Gastroesophageal Reflux Disease | Phase 2 | Completed | XenoPort, Inc. | 460 | 2009-09-01 | 2021-02-21 |
| An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects Sinemet 25-100 Oral Tablet, XP21279, Carbidopa Pill - Parkinson's Disease | Phase 1 / Phase 2 | Completed | XenoPort, Inc. | 14 | 2009-05-01 | 2021-05-05 |
| Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil) open label - Pharmacokinetics, Healthy Volunteer | Phase 1 | Completed | XenoPort, Inc. | 16 | 2009-01-01 | 2013-05-14 |
| A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms Arbaclofen placarbil, 20 mg, Placebo, Arbaclofen placarbil, 30 mg - Back Pain | Phase 2 | Completed | XenoPort, Inc. | 161 | 2008-12-01 | 2021-02-21 |
| Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance GSK1838262 Extended Release Tablets, Placebo - Restless Legs Syndrome, Restless Legs Syndrome (RLS) | Phase 3 | Completed | XenoPort, Inc. | 136 | 2008-10-01 | 2013-07-22 |
| Prevention Study in Adult Patients Suffering From Migraine Headaches GSK1838262, Placebo - Migraine Disorders, Migraine | Phase 2 | Completed | XenoPort, Inc. | 526 | 2008-08-01 | 2013-07-22 |
| A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment GEn 1200mg/day, GEn 3600mg/day - Neuralgia, Postherpetic | Phase 2 | Completed | XenoPort, Inc. | 96 | 2008-03-01 | 2013-07-22 |
| A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN) Placebo, GEn 1200mg/day, GEn 2400mg/day - Neuropathy, Diabetic | Phase 2 | Completed | XenoPort, Inc. | 421 | 2008-03-01 | 2013-07-22 |
| A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN) GEn 1200mg/day, GEn 2400mg/day, GEn 3600mg/day - Neuralgia, Postherpetic | Phase 2 | Completed | XenoPort, Inc. | 376 | 2008-02-01 | 2013-07-22 |
Showing 20 of 28. Sign in to see all of them.
Restless Legs Syndrome (15) · Neuralgia (3) · Gastroesophageal Reflux (2) · Neuralgia, Postherpetic (2) · Parkinson Disease (2) · Back Pain (1) · Diabetic Neuropathies (1) · Migraine Disorders (1) · Multiple Sclerosis (1) · Muscle Spasticity (1) · Parasomnias (1) · Psoriasis (1)
1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid (16) · Gabapentin (5) · BID protein, human (4) · Sugars (4) · arbaclofen placarbil (4) · Carbidopa (2) · Diphenhydramine (2) · carbidopa, levodopa drug combination (2) · Holliday Junction Resolvases (1) · Morphine (1) · Moxifloxacin (1) · Pregabalin (1) · Proton Pump Inhibitors (1)
United States (24) · Canada (3) · Germany (1)
Steven Caras, MD (3) · Dan Chen, M.D. (1) · Dmitri Lissin, M.D. (1) · Jay Huff, M.D. (1) · Mansoor Ahmed, MD (1) · Michael Leong, M.D. (1) · Steve D Caras, MD (1)
PMID 26788345, PMID 27067343, PMID 27288210, PMID 21527006, PMID 12804680, PMID 18166705, PMID 19480225, PMID 20817595, PMID 21677899, PMID 22664749, PMID 23165696, PMID 23186035, PMID 23721547, PMID 23964267, PMID 24102928, PMID 24290737, PMID 25467190