Expired Study
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Troy, Michigan 48083


Purpose:

This study will evaluate efficacy and safety of methylphenidate hydrochloride modified release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).


Criteria:

Inclusion criteria: 1. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood 2. Female patients of childbearing potential must be practicing an acceptable method of contraception. Exclusion criteria: 1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2 2. History of alcohol or substance abuse within the last six months. 3. History of seizures or use of anticonvulsant medication. 4. Any psychiatric condition that requires medication or may interfere with study participation. 5. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc. 6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder 7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma 8. Diagnosis or family history of Tourette's syndrome 9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke Other protocol-defined inclusion/exclusion criteria may apply


Study is Available At:


Original ID:

CRIT124D2302


NCT ID:

NCT01259492


Secondary ID:

2010-021533-31


Study Acronym:


Brief Title:

Efficacy and Safety Study of Methylphenidate Hydrochloride Modified Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (A


Official Title:

A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Modified Release in the Treatment of Adult Patients With Childhood-onset ADHD


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

  • United States: Food and Drug Administration
  • Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
  • Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
  • Belgium: Federal Agency for Medicinal Products and Health Products
  • Germany: Institute for Drugs and Medical Devices
  • Norway: Norwegian Medicines Agency
  • Denmark: Danish Medicines Agency
  • Sweden: Medical Products Agency
  • Singapore: Health Sciences Authority
  • South Africa: Medicines Control Council


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

700


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:November 2010
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:August 2012
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 18, 2012
First Received Date:December 11, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Attention Deficit/Hyperactivity Disorder Rating Scale total score
Time Frame:End of Week 9
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Total score on Sheehan Disability Scale
Time Frame:End of Week 9
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Percentage of treatment failures
Time Frame:at 40 weeks (end of withdrawal period)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percent of patients with clinical improvement on Clinical Global Impression-Improvement Scale.
Time Frame:End of Week 9
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Placebo Comparator: Placebo
Arm Name:Placebo
Intervention Type:Drug
Name:RIT124D
Description:Experimental: Methylphenidate hydrochloride modified release 40 mg
Arm Name:Methylphenidate hydrochloride modified release 40
Intervention Type:Drug
Name:RIT124D
Description:Experimental: Methylphenidate hydrochloride modified release 40 mg
Arm Name:Methylphenidate hydrochloride modified release 60
Intervention Type:Drug
Name:RIT124D
Description:Experimental: Methylphenidate hydrochloride modified release 40 mg
Arm Name:Methylphenidate hydrochloride modified release 80

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Experimental
Arm Name:Methylphenidate hydrochloride modified release 40 mg
Study Arm Type:Experimental
Arm Name:Methylphenidate hydrochloride modified release 60 mg
Study Arm Type:Experimental
Arm Name:Methylphenidate hydrochloride modified release 80 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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