Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning

NCT00418691 | Terminated Phase 3 Results

• 1 other identifier: 2003-0925
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To assess the efficacy of immediate release methylphenidate, sustained release methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of cognitive functioning in patients with brain tumors.

Conditions

Brain Tumor

Keywords

Brain Tumor; Methylphenidate; Ritalin; Modafinil; Provigil; Fatigue; Concentration

Outcome Measures

Primary Outcomes (2)

• Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score

  'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow "trail" made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).

  Baseline to 4-5 weeks on study medication

• Patient Cognitive Test Scores at End of Treatment Period

  For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).

  Baseline to end of Week 4 treatment period

Study Arms (3)

Immediate Release (IR) Methylphenidate

ACTIVE COMPARATOR

10 mg by mouth (PO) twice daily for 4 Weeks

Drug: IR Methylphenidate

Sustained Release (SR) Methylphenidate

ACTIVE COMPARATOR

200 mg PO once daily for 4 Weeks

Drug: SR Methylphenidate

Modafinil

ACTIVE COMPARATOR

18 mg PO once daily for 4 Weeks

Drug: Modafinil

Interventions

IR Methylphenidate DRUG

10 mg by mouth (PO) twice daily x 4 Weeks

Also known as: Ritalin

Immediate Release (IR) Methylphenidate

Modafinil DRUG

200 mg PO Once Daily x 4 Weeks

Also known as: Provigil

Modafinil

SR Methylphenidate DRUG

18 mg PO Once Daily x 4 Weeks

Also known as: Ritalin

Sustained Release (SR) Methylphenidate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with a brain tumor, either primary or metastatic
• Patient had prior radiation treatment to the brain
• Patient is \> or = 18 years of age
• Patient has a Karnofsky performance status (KPS) performance of 70 at baseline
• Patient is using acceptable birth control methods. Female participants (if of child bearing age and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control, including abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization.
• Patient must speak and understand English or Spanish
• Patient has reported cognitive decline and is being considered for stimulant therapy by their neurologist
• Patient has provided written informed consent to participate in the study prior to enrollment to the study

You may not qualify if:

• History of hypersensitivity reaction to methylphenidate or modafinil
• History of severe headaches, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, marked anxiety, tension or agitation
• History of clinically significant pulmonary or cardiac disease
• Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently greater than 140 mm Hg or diastolic pressure consistently greater than 90 mm Hg
• Patients with uncontrolled seizures will be excluded
• Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential
• Moderate to severe depression (\> 20 on Beck Depression Inventory II)
• If taking antidepressants, patient must be on a stable dose
• Currently taking psychostimulants, Monoamine oxidase (MAO) inhibitors, or anticoagulants
• Current use of the following herbals or supplements for fatigue relief (dehydroepiandrosterone (DHEA), S-Adenosyl methionine (SAME), ginkgo, ginseng, St. John's Wort)
• Patients currently taking any erythropoietin type drugs

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Brain Neoplasms; Fatigue

Interventions

Methylphenidate; Modafinil

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Early termination lead to limited analysis.

Results Point of Contact

• Title: Jeffrey Wefel, PHD/ Associate Professor, Neuropsychology
• Organization: UT MD Anderson Cancer Center

jwefel@mdanderson.org

713-563-0514

Study Officials

• Jeffrey S. Wefel, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 5, 2007
• Study Start: February 1, 2004
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 23, 2020
• Results First Posted: May 6, 2011

Record last verified: 2020-09

Locations

US (1)