Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)

Impax Laboratories

Status and phase: Completed; Phase 2

Conditions: Restless Legs Syndrome

Treatments: Drug: IPX159; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521663

IPX159-B11-02

Details and patient eligibility

About

The purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.

Full description

IPX159 was developed as an extended release formulation to reduce the fluctuation in nefopam concentration compared to IR and to reduce the incidence of peak or rate related side effects.

Enrollment: 159 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to understand and willing to sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization
2. Males and females aged 18-70 with a history of primary RLS for ≥6 months prior to screening
3. Symptoms of RLS by medical history on at least 15 nights during the month prior to Screening
4. BMI 18.5-32
5. Negative alcohol and drug abuse screen
6. Negative serum pregnancy test
7. Agrees to use a medically acceptable method of contraception throughout the study and for 2 months after completing the study.
8. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

Exclusion criteria

1. Subjects who use or intend to use post screening the following medications or medication categories:

   • Sedative hypnotics, trazodone
   • Dopamine agonists, gabapentin, gabapentin enacarbil, pregabalin
   • Narcotic analgesics, other opioids, tramadol, cyclobenzaprine
   • Iron supplementation therapy

2. History of HIV, hepatitis B or C

3. Pregnant or breastfeeding.

4. History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood.

5. History or presence of glaucoma

6. Planning to take herbal medications (eg, hypericum perforatum [St John's Wort], licorice, ephedra, ginkgo, ginseng) during the study.

7. Use of any investigational drug within the last 30 days or within a period of 5 times the drug's half-life, whichever is longer

8. Subjects who, in the opinion of the Investigator, should not participate in the study or are not capable of following the study schedule for any reason

9. Employees or family members of the Investigator, study site, the Sponsor, or Contract Research Organization (if any)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 2 patient groups, including a placebo group

IPX159

Experimental group

Description:

IPX159 90 mg daily at week 1 with titration to 180 mg daily at week 2 with possible titration to 270 mg daily at week 3.

Treatment:

Drug: IPX159

Sugar Pill

Placebo Comparator group

Description:

IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2.

Treatment:

Drug: Placebo