Conditions

Multiple Sclerosis

Keywords

Central Neuropathic PainMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.
Baseline, 6 weeks

Secondary Outcomes (27)

Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)
Baseline, 6 weeks
Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks
6 weeks
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
Baseline, 6 weeks
Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)
Baseline, 6 weeks
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Baseline, 6 weeks
+22 more secondary outcomes

Other Outcomes (8)

Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)
Baseline, 6 weeks
Change From Baseline in Creatinine at Week 6 (Acute Phase)
Baseline, 6 weeks
Change From Baseline in the Platelet Count at Week 6 (Acute Phase)
Baseline, 6 weeks
+5 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Duloxetine

EXPERIMENTAL

Drug: Duloxetine Hydrochloride (HCI)

Interventions

Duloxetine Hydrochloride (HCI)DRUG

Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).

Also known as: LY248686, Cymbalta

Duloxetine

PlaceboDRUG

Participants received placebo oral (po), once daily (QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 milligrams \[mg\] QD for 12 weeks).

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have central neuropathic pain due to multiple sclerosis (MS) based on the disease diagnostic criteria
Adult males or females
Have a score of 4 or greater on the daily 24-hour average pain score
Females must test negative for pregnancy at study entry
Complete the daily diaries for at least 70% of the days of the study
Participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study Disease Diagnostic Criteria:
Diagnosis of MS at least 1 year prior to study entry
No MS flares or change in disease treatment for the 3 months prior to study entry
Daily pain due to MS for a minimum of 3 months prior to study entry

You may not qualify if:

Are currently in a clinical trial of MS disease-modifying therapy
Have pain that cannot be clearly differentiated from causes other than MS
Any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
History of substance abuse or dependence
Are pregnant or breast-feeding

Contact the study team to confirm eligibility.