A Study to Test the Use of Duloxetine for Pain in MS

NCT00457730 | Completed Phase 2 Results

• 2 other identifiers: 1083575WIRB Protocol Number: 20061712
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients with Multiple Sclerosis experience pain that is caused by the effects of MS on the nervous system. The purpose of this study is to see if an investigational drug (Duloxetine) will reduce pain in subjects with MS. The US Food and Drug administration (FDA) has approved this drug for use with depression or pain from diabetes.However, it is considered investigational for this study because it has not been approved for patients with MS. This study will recruit patients with MS who have central pain which is 4 or greater on a scale of 1-10. Patients must have experienced pain for 2 months or longer prior to begining the study.The study will last 10 weeks, patients will be randomized either Duloxetine or placebo and will be carefully monitored throughout the study. Patients will keep pain/sleep diaries during the study period and will be provided Ibuprofen for pain control.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Duloxetine; Pain

Outcome Measures

Primary Outcomes (1)

• Percent Change in Worst Pain Score

  Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.

  at week 6

Secondary Outcomes (2)

• Percent Change in Average Pain Score.

  at week 6

• Global Impression of Change

  Week 6 vs baseline

Study Arms (2)

Duloxetine

EXPERIMENTAL

subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.

Drug: Duloxetine

placebo

PLACEBO COMPARATOR

matched placebo medication

Drug: Placebo

Interventions

Duloxetine DRUG

Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.

Also known as: Cymbalta

Duloxetine

Placebo DRUG

Subjects are randomized to either Duloxetine or Placebo

Also known as: Sugar Pill

placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of MS made at least 3 months prior based on McDonald or Proser criteria.
• Age over 17.
• Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 90 days prior to screening.
• Daily pain attributed to MS, present for a minimum of 2 months prior to screening.
• Minimum baseline score of 4 on the 24-h Worst Pain Score rated on an 11 point (0-10) point Likert Scale within the identified region of central pain.

You may not qualify if:

• Pain that could not clearly be differentiated from causes other than Multiple Sclerosis, such as diabetic neuropathy, PVD, arthritis or other musculoskeletal condition, chronic headache, visceral pain.
• Transient pains such as dysesthetic L'Hermittes sign alone.
• Current or historical diagnosis of mania, bipolar disorder or psychosis.
• Concomitant use of monoamine oxidase inhibitors (MAOI) or thioridazine.(MAOI drug must be discontinued 14 days prior to enrollment. At least 5 days must have passed after study drug discontinuation before MAOI drug may be started.)
• Concomitant use of a serotonin reuptake inhibitor or venlafaxine or duloxetine within 4 weeks of baseline.
• Use of any analgesic medication except ibuprofen for neurogenic pain 7 days prior to the baseline visit and until study termination.
• Use of an opioid, marijuana or dronabinol within 7 days of baseline.
• Narrow angle glaucoma.
• Depression with suicidality.
• History of chronic hepatic insufficiency or ALT or AST\> twice the upper limit of normal. Because it is possible thast Duloxetine may aggravate pre exisitng liver disease, duloxetine should not be prescribed to patients with chronic liver disease.
• Renal insufficiency (Creatinine Clearance , 30mL/minor serum creatinine \> 1.9). Duloxetine is not recommended for patients with end stage renal disease (requiring dialysis) or severe renal impairment. Population PK analyses suggest that mild to moderate degrees of renal dysfunction (estimated CrCl 30-80ml/min)have no significant effect on Duloxetine clearance. We will calculate creatinine clearance using the Cockcroft-Gault calculation. This is the most common calculation used in FDA producy labeling: Males=(140-age)(wt in kg)(serum creatinine)(72). Females= malesx 0.85.
• Uncontrolled hypertention (SBP\>180, DBP\>105)
• Females who are breast feeding, pregnant, or have potential to become pregnant during the course of the study.(fertile and unwilling/unable to use effective contraceptive measures)
• Any other serious and/or unstable medical condition.
• Allergy to ibuprofen or any other non steroidal anti inflammatory drug (NSAID)

Sponsors & Collaborators

• Brown, Theodore R., M.D., MPH: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Evergreen Healthcare

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Pain

Interventions

Duloxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Theodore R. Brown, MD Principle Investigator
• Organization: MS Center at Evergreenhealth Care

trbrown@evergreenhealth.com

425-899-5350

Study Officials

• Theodore R Brown, MD.MPH

  Evergreen Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 27, 2015
• Results First Posted: April 6, 2015

Record last verified: 2015-04

Locations

US (1)