Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study

Viatris

Status: Terminated

Conditions: Painful Diabetic Peripheral Neuropathy; Fibromyalgia

Treatments: Other: prior authorization; Other: no prior authorization

Study type: Observational

Funder types: Industry

Identifiers

NCT01280747

A0081247

Details and patient eligibility

About

The investigators hypothesize that fibromyalgia (FM) and painful diabetic peripheral neuropathy (pDPN) patients with access restrictions on pregabalin will lead to higher healthcare resource use and cost compared to patients without such restrictions on pregabalin in a naturalistic setting. The randomization will occur at the physician level and not the patient level.

Full description

This trial was terminated prematurely on April 2, 2012, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A physician-confirmed diagnosis of either pDPN or FM, but not both.
• Initiation of a medication for pDPN or FM is clinically indicated, either as monotherapy or in combination with other treatments, as determined by the treating physician, and agreed to by the patient.
• No prior pregabalin use or pregabalin PA requests.

Exclusion criteria

• Age < 18 years at time of study enrollment.
• Females or are partners of males currently pregnant/lactating or intending to become pregnant in the next 6 months
• Physician-confirmed diagnosis of both pDPN and FM.

Trial design

42 participants in 4 patient groups

1

Description:

Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place

Treatment:

Other: prior authorization

Other: prior authorization

2

Description:

Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place

Treatment:

Other: no prior authorization

Other: no prior authorization

3

Description:

Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place

Treatment:

Other: prior authorization

Other: prior authorization

4

Description:

Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place

Treatment:

Other: no prior authorization

Other: no prior authorization