A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury

NCT00557973 | Completed Phase 2

• 1 other identifier: XP-B-065
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury

Conditions

Muscle Spasticity

Outcome Measures

Primary Outcomes (1)

• Maximum Ashworth score

  Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose. Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment

  Day 17

Secondary Outcomes (3)

• Average Ashworth score

  Day 17

• Two Highest Ashworth scores

  Day 17

• Average Non-zero Ashworth Scores

  Day 17

Study Arms (3)

XP19986 SR1 10 mg - Placebo

EXPERIMENTAL

Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.

Drug: XP19986 SR1, 10 mg BID; Drug: Placebo

XP19986 SR1 20 mg - Placebo

EXPERIMENTAL

Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.

Drug: XP19986 SR1, 20 mg BID; Drug: Placebo

XP19986 SR1 30 mg - Placebo

EXPERIMENTAL

Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.

Drug: XP19986 SR1, 30 mg BID; Drug: Placebo

Interventions

XP19986 SR1, 10 mg BID DRUG

XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Also known as: Sustained release Polyox WSR N750, 10 mg

XP19986 SR1 10 mg - Placebo

XP19986 SR1, 20 mg BID DRUG

XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Also known as: Sustained release Polyox WSR N750, 20 mg

XP19986 SR1 20 mg - Placebo

XP19986 SR1, 30 mg BID DRUG

XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Also known as: Sustained release Polyox WSR N750, 30 mg

XP19986 SR1 30 mg - Placebo

Placebo DRUG

Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.

Also known as: sugar pill

XP19986 SR1 10 mg - Placebo; XP19986 SR1 20 mg - Placebo; XP19986 SR1 30 mg - Placebo

Eligibility Criteria

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

You may qualify if:

• Spasticity secondary to traumatic spinal cord injury between C-5 and T-12 spinal cord levels, at least 12 months post-injury with a stable neurological deficit

You may not qualify if:

• Traumatic brain injury or cognitive deficit of any etiology that may influence compliance with study procedures or outcome measures

Sponsors & Collaborators

• XenoPort, Inc.: lead

Study Sites (11)

Unknown Facility

Downey, California, United States

Location

Unknown Facility

Gilroy, California, United States

Location

Unknown Facility

Pasadena, California, United States

Location

Unknown Facility

San Jose, California, United States

Location

Unknown Facility

Englewood, Colorado, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

BID protein, human; Sugars

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Michael Leong, M.D.

  XenoPort, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: December 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

US (11)