Past Studies

Research Trials

Acute Stroke – 1997

Alzheimer’s Disease – 1998

Efficacy and long term tolerability of XXX in patients with moderately severe to severe Alzheimer’s Disease.

Epilepsy

XXX in combination with newer and older antiepileptic drugs and as mono-therapy.

Epilepsy -1999

Safety and Therapeutic Effect of XXX in patients with Partial Seizures.

Acute Stroke-1999

Phase IIa. Inpatient

HIV Neuropathy -1999

Stroke Prevention -1999

Phase III

Seizure Management -2000

Phase IV

Hypercholesterolemia-2001

Vascular Dementia -2002

Phase III

Hypercholesterolemia -2002

Migraine Disorder-2002

Phase II

Double-Blind Randomized Multi-center, Parallel Group Study to establish Dose     response, safety and efficacy of XXX as mono-therapy in patients with newly diagnosed epilepsy. 2002

A 6 week, open label, dose comparison study to evaluate the safety and efficacy of XXX versus XXX, XXX and XXX in subjects with Hypercholesterolemia. 2001

An open label, randomized, multi-center, Phase lllb, parallel group switching study to compare the efficacy and safety of lipid lowering agents XXX and XXX with XXX high risk subjects with type IIa and IIb Hypercholesterolemia. 2001

A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of XXX for a single moderate or severe headache in adults diagnosed with Migrainous disorder. 2002

A multi-center, double-blind, randomized study to evaluate the safety and efficacy of XXX compared with placebo in subjects with painful diabetic neuropathy. 2002

An open label study to evaluate the safety of XXX in subjects with Painful Diabetic Neuropathy. 2003

A multi-center, double-blind, randomized, placebo-controlled, parallel group trial to investigate the efficacy and safety of XXX as adjunctive therapy in subjects with partials seizures with or without secondary generalization. 2003

An open label extension trial to determine tolerability and efficacy of long-term oral XXX as adjunctive therapy in patients with Partial Seizures. 2003

Safety evaluation of XXX with opiod tolerant patients. 2003

A Phase III, randomized, double-blind, placebo-controlled, outpatient, safety and efficacy study of XXX in adults subjects with Chronic Insomnia. 2002

A Phase II Double-Blind, randomized, dose ranging, placebo-controlled , multi-center, safety and efficacy evaluation of three doses of XXX in patients with mild to moderate dementia of the Alzheimer’s Type. 2003

A Fourteen week placebo controlled dose response efficacy and safety study of XXX in early Parkinson’s Disease Patients. 2003

A randomized, double blind, placebo controlled, parallel-group, single attack study to evaluate the onset of efficacy of a new formulation of XXX in the acute treatment of Migraine. 2003

A dose-ranging, placebo controlled study of XXX at the dose of XXX for 12 weeks in patients with mild to moderate Alzheimer’s Disease. 2003

A randomized, double-blind, placebo controlled trial to evaluate the safety and efficacy of XXX in slowing the progression of Alzheimer’s Disease. 2003

A one year, multi-center, randomized, double-blind, placebo-controlled evaluation of efficacy and safety of XXX in subjects with Mild Cognitive Impairment. 2003

A 5-Week , randomized, Double-blind, placebo-controlled, placebo-controlled, multi-center study of XXX in patients with Postherpetic Neuralgia who are XXX treatment failures. 2004

A Multi-center, open-label trial to assess subject preference of XXX, orally disintegrating tablets, compared to conventional XXX in subjects with stable Parkinson’s Disease. 2004

A 4-Week randomized, Multi-center, double-blind, placebo-and-active-controlled, parallel-group, forced-titration Phase IIb study comparing efficacy and safety of ascending doses of XXX prolonged release up to 20mg BID to placebo in subjects with moderate to severe chronic pain due to Osteoarthritis of the knee. 2005

A Multi-center, randomized, double-blind, placebo controlled study assessing the safety and efficacy of XXX in patients in patients with Postherpetic Neuralgia. 2004

A randomized, parallel-design, multi-center study to evaluate the efficacy of XXX for the Treatment of Chronic Low Back Pain. 2004

A randomized, double blind, placebo-controlled, parallel group Phase 2 Study to evaluate the Safety and Efficacy of XXXX in subjects with mild to moderate Alzheimer’s Disease. 2004

A multi-center double blind randomized parallel group evaluation of XXX extended release Adjunctive therapy in subjects with Partial Seizures. 2004

A multi-center double blind randomized parallel group evaluation of XXX extended release adjunctive therapy in patients with primary generalized Tonic- Clonic Seizures. 2004

A multi-center randomized double blind placebo-controlled, parallel group trial to assess the efficacy and safety of XXX in subjects with Painful Distal Diabetic Neuropathy. 2005

A randomized double blind parallel group, placebo controlled single –attack evaluation of the efficacy and tolerability of XXX verses Placebo when administered during the mild pain phase of a migraine. 2004

A multi-center, open label follow on trial to assess the long term safety and efficacy of XXX in subjects with Painful Distal Diabetic Neuropathy. 2004

A randomized double blind placebo controlled study to assess the subjective response to treatment with XXX in adult subjects with Chronic Insomnia by utilizing an interactive voice response system for collecting diary data. 2005

Phase 3 multi-center randomized double blind placebo controlled study of the effect of daily treatment with XXX on measures of cognitive and global function in subjects with mild to moderate dementia of the Alzheimer’s Type. 2005

A prospective multi-center randomized open label study with blinded raters to evaluate the effects of immediate versus delayed switch to XXX on motor function

And quality of life in patients with Parkinson’s disease with-end-of dose wearing off. 2005

A randomized multi-center double blind placebo-controlled, 18-month study of the efficacy of XXX in patients with mild to moderate dementia of the Alzheimer’s Type. 2005

A multi-center, randomized double blind placebo controlled Five arm parallel group trial to investigate the efficacy and safety of four different transdermal doses of XXX in subjects with Idiopathic Restless Legs Syndrome. 2005

A pilot randomized double blind placebo controlled study to evaluate the efficacy of XXX and XXX in the treatment of Chronic Lumbosacral  Radiculopathy. 2005

A randomized double blind double blind placebo-controlled study of the safety and efficacy of XXX extended release tablets in treatment of patients with Postherpetic Neuralgia. 2005

An open- label exploratory study with XXX of selective measures of volumetric MRI and cognition in patients with Moderate Dementia of the Alzheimer’s Type. 2005

Safety, tolerability and efficacy study of oral XXX administered for ninety days in subjects with Probable Alzheimer’s of mild to moderate Severity. 2005

A phase 2 double-blind randomized, placebo-controlled, parallel-group, multi-center proof-of-concept study to evaluate the safety and efficacy of XXX taken in combination with XXX for the treatment of subjects with Chronic Insomnia. 2005

A randomized, double- blind, multi-center, placebo-controlled, cross-over study to determine the consistency of response for XXX administered during the mild pain phase for the acute treatment of multiple migraine attacks. 2005

A randomized, double-blind, Placebo-controlled, Multi-center Phase 3 study to evaluate the safety and the safety of XXX once daily and XXX twice daily for 12 weeks for the treatment of Opiod-induced Bowel Dysfunction in Adults taking Opiod Theraphy for persistent Non-Cancer Pain. 2005

A randomized, double-blind, placebo-controlled, multi-center Phase 3 study to evaluate the Long-Term  Safety of XXX twice daily for 12 months for the treatment of Opiod-Induced Bowel Dysfunction in Adults taking Opiod Theraphy for Persistent Non-Cancer Pain. 2004

A multi-center study evaluating the efficacy and safety of XXX as headache prophylaxis in Migraine Patients with 15 or more headache days per 4-week  period in a 24-week, double blind, randomized, placebo-controlled, parallel-group phase followed by a 32-week open-label extension. 2006

A double-blind, randomized, placebo-controlled study of the efficacy, safety and tolerability of 8 week treatment of XXX in sleep disturbed community dwelling, mild to moderately severe Alzheimer’s Disease Subjects. 2006

A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early XXX treatment versus delayed XXX treatment in patients with new onset of Parkinson’s disease. 2006

XXX Dose-range finding trial: A 16-week, randomized, double-blind, placebo and XXX controlled, multi-center trial of XXX in patients with Post herpetic Neuralgia. 2006

A randomized , double-blind ,placebo-controlled , multi-center, phase 2 study designed to assess the efficacy and safety of XXX immediate release in subjects with Chronic pain from Low Back Pain or  Osteoarthritis of the Hip or Knee. 2006

A multi-center trial evaluating the efficacy of XXX for symptomatic treatment of pain in patients with Multiple Sclerosis. 2006

A multi-center trial evaluating the efficacy of XXX for the symptomatic treatment of pain in patients with Diabetic Peripheral Neuropathy. 2006

A prospective, Multi-center clinical evaluation of XXX in combination with a XXX for the management of chronic back pain with or without leg pain. 2006

A multi-center, randomized, double-blind, placebo-controlled, parallel group study of the efficacy, safety, and tolerability of XXX in XXX treated Parkinson’s disease patients with motor fluctuations. 2006

Phase 3 multinational, randomized, double-blind, placebo controlled study of the effect of daily treatment with XXX on measures of cognition, activities of daily living and global function in the subjects with mild dementia of the Alzheimer’s Type. 2006

A multi-center, randomized, double-blind, placebo-controlled, parallel- group study of oral XXX for the treatment of Opiod Induced bowel Dysfunction in subjects with chronic non malignant pain. 2006

Open-label, multi-center, effectiveness and safety study of once daily XXX as mono or adjunct therapy in patients with Idiopathic Parkinson’s Disease. 2006

Randomized evaluation of recurrent stroke comparing XXX closure to establish current standard of care treatment. 2006

A prospective, 5-week, open-label, randomized, multi-center, parallel-group study with a 20-week, open-label extension evaluating the tolerability and safety of switching from XXX to an initial dose of XXX patch formulation in patients with probable Alzheimer’s disease. 2006

An open-label extention trial assessing the safety and tolerability of XXX in patients with Postherpetic Neuralgia. 2006

Open label study of the effect of daily treatment with XXX in subjects with Dementia of the Alzheimer’s type. 2006

A randomized double-blind, placebo and active-control, parallel-arm, phase III trial with controlled adjustment of dose to evaluate the efficacy and safety of XXX extended release in subjects with moderate to severe chronic pain due to Osteoarthritis of the knee. 2007