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CLEVELAND SLEEP RESEARCH CENTER

18100 Jefferson Park Road, Suite 101
Middleburg Heights, OH 44130

Tel: 440-243-8044

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Previous Studies

  • E2006-G000-304: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older with Insomnia Disorder. EISAI.

  • 14-005: A long term, open-label safety and maintenance of efficacy study of JZP-110 [®-2-amino-3-phenylproylocarbamate hydrochloride] in the treatment of excessive sleepiness in subjects with narcolepsy or obstructive sleep apnea. Jazz Pharmaceuticals.

  • 14-002: A twelve-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP-110 [®-2-amino-3-phenylproylocarbamate hydrochloride] in the treatment of excessive sleepiness in subjects with narcolepsy. Jazz Pharmaceuticals.

  • 14-003: A twelve-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP-110 [®-2-amino-3-phenylproylocarbamate hydrochloride] in the treatment of excessive sleepiness in subjects with obstructive sleep apnea (OSA). Jazz Pharmaceuticals.

  • XP-IIT-0031: Evaluation of the effects of gabapentin enacarbil on intensity of cortical arousal, heart rate, blood pressure, and Anterior Tibialis EMG responses associated with Periodic Limb Movements during sleep in patients with restless legs syndrome using a novel computer assisted scoring system. XenoPort, Inc.

  • DS5565-A-E311: A randomized, double-blind, placebo- and active-controlled study of DS-5565in subjects with pain associated with fibromyalgia. Daichi Sankyo Pharam Development.

  • DS5565-A-E312: An open-label extension study of DS-5565 for 52 weeks in pain associated with fibromyalgia. Daichi Sankyo Pharam Development

  • CTT116855: A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI with the fixed dose dual combinations of FF/VI and UMECH/VI, all administered one-daily in the morning via a dry powder inhaler in subjects with chronic obstructive pulmonary disease.  GlaxoSmithKline.

  • HZA116863: A randomized, double-blind, parallel group, multicenter study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the treatment of persistent asthma in adults and adolescents. GlaxoSmithKline.

  • RXP114025: Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in the Treatment of Subjects With Moderate-to-Severe Primary Restless Legs Syndrome (RLS). GlaxoSmithKline/ Xenoport.

  • A Safety and Benefit Study of inhaled Fluticasone Propionate/ salmeterol combination versus inhaled Fluticasone propionate in the treatment of adult and adolescent subjects with persistent asthma (“Study”). Glaxo-SmithKline.

  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and Additional Antihypertensive Medication, Bristol Myers Squib, Astra-Zeneca

  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) or Additional Antihypertensive Medication. Bristol Myers Squib, Astra-Zeneca

  • A randomized, placebo-controlled, double blind, fixed –dose study of the efficacy and safety of eszopiclone in children (6-11 years) and adolescents (12 to 17 years) with attention-deficit/hyperactivity disorder-associated insomnia. Sunovion. 2010-2011.

  • A long-term, open label, safety study of eszopiclone in children (6-11 years) and adolescents (12 to 17 years) with attention-deficit/hyperactivity disorder-associated insomnia. Sunovion, 2010-2011

  • A Randomized, Double blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysmnography Study of Pregabalin and Pramipexole in Adults with Restless Legs Syndrome. Pfizer, 2009-2011.

  • A multicenter, randomized, double-blind, placebo-controlled study to evaluate cardiovascular outcomes following treatment with Alogliptin in addition to standard of care in subjects with type 2 diabetes and acute coronary syndrome. Takeda, 2009.

  • A Polysomnography study of GSK1838262 (XP13512) extended release tablets versus placebo in the treatment of Restless Legs Syndrome (RLS) and associated sleep disturbance. GlaxoSmithKline, 2008.

  • A long-Term study of XP 13512 vs. Placebo Treatment assessing maintenance of Efficacy and Safety in Patients with Restless Leg Syndrome. Xenoport, 2006-2007.

  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyremâ (sodium oxybate) with Placebo for the Treatment of Fibromyalgia. Jazz Pharmaceuticals.

  • Assessment of Serevent (Advair) in patients with Asthma. GlaxoSmithKline.

  • A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter, Fixed Dose, Polysomnographic Study of PD 0200390 in Patients with Primary Insomnia.

  • A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 mg/day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome.

  • A 12 Month. Open-Label, Flexible-Dosage (100-250 mg/day) Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder.

  • Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyremâ (sodium oxybate) with modafinil with Placebo for the Treatment of Daytime Sleepiness in Narcolepsy.

  • A 12 Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome.

  • A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK-0928 in Adult Patients with Insomnia.

  • A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Rozerem ™ Taken in Combination with Gabapentin for the Treatment of Subjects with Chronic Insomnia.

  • A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate Effects of APD125 in Patients With Insomnia.

  • A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Long Term Efficacy and Safety of Doxepin HCL in Primary Elderly Insomnia Patients with Sleep Maintenance Difficulties.

  • Efficacy and Safety of Eplivanserin 5 mg/day in Sleep Maintenance Insomnia: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Treatment Phase Extension with Eplivanserin for 40 Weeks Period.

  • The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects with Insomnia Related to Generalized Anxiety Disorder (GAD): A Randomized, Double-Blind, Placebo-Controlled. Parallel-group, Adjunctive Therapy Trial.