Clinical Trials Sponsored by Zalicus

Total 78 results

Zalicus

Completed

A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA

Rheumatoid Arthritis
Zalicus

Completed

A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis (Synergy)

Rheumatoid Arthritis

United States
Zalicus

Completed

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis (MARS-1)

Rheumatoid Arthritis

United States, Poland, Argentina, Romania, Serbia, Canada, Estonia, Russian Federation, Lithuania, South Africa, Hungary, Mexico
Zalicus

Completed

Phase I Study of Topical CRx-191 in Normal Healthy Volunteers

Healthy

Germany
Zalicus

Terminated

CRx-102 Osteoarthritis Multicenter Evaluation Trial (COMET-1)

Knee Osteoarthritis

United States, Canada
Zalicus

Completed

Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia (PHN)

Postherpetic Neuralgia

United States
Zalicus

Completed

Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy

Lumbosacral Radiculopathy

United States
Zalicus

Terminated

Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Serbia
Zalicus

Completed

A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque Psoriasis (197-002)

Plaque Psoriasis

Germany
Zalicus

Completed

Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes

Type 2 Diabetes

Canada
Zalicus

Completed

A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

Atopic Dermatitis

Germany
Zalicus
Bioskin GmbH

Completed

Study of CRx-191 to Assess Activity in Plaque Psoriasis

Plaque Psoriasis

Germany
Validus Pharmaceuticals

Terminated

DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder

Bipolar Disorder

United States
Validus Pharmaceuticals

Completed

Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

Bipolar Disorder
Validus Pharmaceuticals

Completed

The Young Adult and Pediatric Bipolar Study

Bipolar I Disorder

United States
Validus Pharmaceuticals

Completed

Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

Bipolar Disorder
Amicus Therapeutics

Recruiting

A Global Prospective Observational Registry of Patients With Pompe Disease

Pompe Disease

United States
Amicus Therapeutics

Recruiting

A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease

Fabry Disease

Spain, United States, Japan, Australia, France, Portugal
Amicus Therapeutics

Active, not recruiting

Gene Therapy for Children With CLN3 Batten Disease

Batten Disease | CLN3

United States
Amicus Therapeutics

Completed

Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease

Fabry Disease

Canada, Belgium, United States, Australia, Netherlands
Amicus Therapeutics

Completed

A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients

Gaucher Disease | Gaucher Disease, Type 1 | Type 1 Gaucher Disease

United Kingdom, United States
Amicus Therapeutics

Completed

Survey to Identify Burdens and Unmet Needs of Patients With Epidermolysis Bullosa

Epidermolysis Bullosa

United States
Amicus Therapeutics

Completed

A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers

Fabry Disease

Netherlands
Amicus Therapeutics

Completed

A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects

Fabry Disease

Australia
Amicus Therapeutics

Completed

Migalastat Food Effect Study

Fabry Disease

United States
Amicus Therapeutics

Terminated

A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101

Type 1 Gaucher Disease

United States, United Kingdom
Amicus Therapeutics

Recruiting

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

Fabry Disease

United States
Amicus Therapeutics

Recruiting

ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD

Pompe Disease (Late-onset)

United States, Taiwan, Japan, Australia, Canada
Amicus Therapeutics

Active, not recruiting

A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD

Pompe Disease (Late-onset)

United States, Germany, Taiwan, Belgium, Australia, Slovenia, Spain, Netherlands, Hungary, Japan, Austria, United Kingdom, France, Argentina, Canada, Sweden, Denmark, New Zealand, Greece, Korea, Republic of, Bosnia and Herzegovina, Ita... and more
Amicus Therapeutics

Available

Expanded Access for ATB200/AT2221 for the Treatment of IOPD

Pompe Disease Infantile-Onset

Taiwan, United States, Italy
Amicus Therapeutics

Available

Expanded Access for ATB200/AT2221 for the Treatment of Pompe Disease

Pompe Disease
Amicus Therapeutics

Active, not recruiting

Long-Term Follow Up of CLN6 Batten Disease Subjects Following Gene Transfer

Batten Disease | CLN6

United States
Amicus Therapeutics

Completed

Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)

Fabry Disease

United Kingdom, United States
Amicus Therapeutics

Approved for marketing

Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease

Fabry Disease

United States, Australia
Amicus Therapeutics

Completed

A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Fabry Disease

Australia, Brazil
Amicus Therapeutics

Completed

A Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Fabry Disease

United States
Amicus Therapeutics

Terminated

Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study

Fabry Disease

United Kingdom, United States, Australia, Brazil, France
Amicus Therapeutics

Completed

A 24-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Fabry Disease

France, United Kingdom
Amicus Therapeutics

Terminated

Study to Evaluate the Safety of AT2220 (Duvoglustat) in Pompe Disease

Pompe Disease

United States
Amicus Therapeutics

Completed

A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014)

Fabry Disease
Amicus Therapeutics

Recruiting

A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18 (ROSSELLA)

Glycogen Storage Disease Type II Infantile Onset

Taiwan, United States, France, Germany, Italy, United Kingdom
Amicus Therapeutics

Active, not recruiting

First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221

Pompe Disease

United States, Netherlands, United Kingdom, Australia, Germany, New Zealand
Amicus Therapeutics

Active, not recruiting

Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease

Fabry Disease

United States, United Kingdom
Amicus Therapeutics

Completed

A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease (PROPEL)

Pompe Disease (Late-onset)

United States, Australia, Korea, Republic of, Japan, Taiwan, Belgium, Slovenia, New Zealand, United Kingdom, France, Argentina, Canada, Spain, Bosnia and Herzegovina, Germany, Sweden, Hungary, Austria, Bulgaria, Denmark, Greece, I... and more
Amicus Therapeutics

Completed

A Study to Describe the Experience of Both Patients and Their Clinicians in the Treatment of Fabry Disease With Enzyme Replacement Therapy.

Fabry Disease

Japan, Taiwan, Turkey, United States, Brazil
Amicus Therapeutics

Terminated

Natural History Study of Batten Disease

Batten Disease | Neuronal Ceroid Lipofuscinosis CLN6 | Neuronal Ceroid Lipofuscinosis CLN3

United States
Amicus Therapeutics

Completed

Gene Therapy for Children With Variant Late Infantile Neuronal Ceroid Lipofuscinosis 6 (vLINCL6) Disease

Variant Late-Infantile Neuronal Ceroid Lipofuscinosis

United States
Amicus Therapeutics

Completed

Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease

Fabry Disease

United States, Austria, United Kingdom, Argentina, Australia, Belgium, Brazil, Canada, Denmark, Egypt, France, Italy, Japan, Spain, Turkey
Amicus Therapeutics

Terminated

STRIDE Study - A Study in Subjects With LOPD Who Are Currently Being Treated With ERT

Late-onset Pompe Disease

United States, Canada, Australia, Belgium
Amicus Therapeutics

Completed

Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease

Fabry Disease

France, Austria, United States, Belgium, Japan, United Kingdom, Denmark, Brazil, Australia, Italy

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