Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

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Shire

Status and phase

Terminated
Phase 3

Conditions

Schizophrenia

Treatments

Drug: SPD489

Study type

Interventional

Funder types

Industry

Identifiers

NCT01760993
2012-003920-18 (EudraCT Number)
SPD489-336

Details and patient eligibility

About

The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Full description

Not required

Enrollment

2 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 to 65 years of age
  • Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
  • Fixed home/place of residence and can be reached by telephone
  • On a stable dose of antipsychotic medications
  • Able to swallow capsules

Exclusion criteria

  • -Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
  • Treated with clozapine in past 30 days
  • Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
  • History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
  • Uncontrolled hypertension
  • History of thyroid disorder that has not been stabilized on thyroid medication
  • Glaucoma
  • Pregnant or nursing
  • Subject has received an investigational product or participated in a clinical study within 30 days

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

SPD489
Experimental group
Treatment:
Drug: SPD489

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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