Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury

NCT01621113 | Completed Phase 2 DMC

• 2 other identifiers: D-732-12H133N110020
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of treatment with dalfampridine in combination with locomotor training in persons with chronic, motor incomplete SCI.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injuries; 4-Aminopyridine; Physical Therapy Modalities; Randomized Controlled Trial; Rehabilitation; Walking

Outcome Measures

Primary Outcomes (1)

• Change in 6-Minute Walk Test (6MWT) Distance at 10 Weeks

  The 6MWT measures the distance (in meters) walked within 6 minutes. The test is a measure of endurance; however, can also be used to measure walking speed.

  Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) Visits

Secondary Outcomes (24)

• Change in 10-Meter Walk Test (10MWT) Speed at 10 Weeks

  Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22)

• Change in Timed 25-foot walk (T25FW) Speed at 10 Weeks

  Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22)

• Change in Walking Index for Spinal Cord Injury II (WISCI II) Scores at 10 Weeks

  Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22)

• Change in Spinal Cord Injury Functional Ambulation Index (SCI-FAI) Scores at 10 Weeks

  Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22)

• Changes on International Standards for Neurological Classification of Spinal Cord Injury at 10 Weeks

  Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22)

Study Arms (2)

Locomotor Training + Dalfampridine

EXPERIMENTAL

Subjects randomized to this group will undergo 10 weeks of double-blind treatment with extended release dalfampridine tablets (10 mg twice daily) while simultaneously receiving locomotor training therapy (5 sessions per week x 10 weeks = 50 sessions total).

Drug: Dalfampridine

Locomotor Training + Placebo

PLACEBO COMPARATOR

Subjects randomized to this group will undergo identical treatment, but will take placebo tablets while simultaneously receiving locomotor training therapy (5 sessions per week x 10 weeks = 50 sessions total).

Drug: Placebo

Interventions

Dalfampridine DRUG

Dalfampridine 10 mg tablet, twice-daily, for 10 weeks

Also known as: Ampyra, Fampridine Sustained Release (Fampridine-SR), 4-Aminopyridine (4-AP)

Locomotor Training + Dalfampridine

Placebo DRUG

Placebo tablet, twice daily, for 10 weeks.

Locomotor Training + Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years, inclusive;
• Neurological impairment secondary to a traumatic spinal cord injury that occurred at least twelve (12) months prior to the screening visit;
• Neurological level of the injury between C4 and T10, inclusive;
• The injury is classified as motor incomplete (AIS grade C or D);
• Able and willing to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions.

You may not qualify if:

• The participant is a lactating female, or a female of childbearing potential who is sexually active, has not had a hysterectomy or oophorectomy, and is not using an approved birth control method (e.g. tubal ligation, implantable contraception device, oral or injectable contraceptive, barrier method, or sexual activity restricted to vasectomized partner);
• The participant has a history of seizures or treatment for seizure disorders;
• The participant has renal impairment (Creatinine Clearance \< 80 mL/min);
• The participant has a known allergy to pyridine-containing substances or any of the inactive ingredients of the dalfampridine;
• The participant has a clinically significant abnormal laboratory values or an abnormal electrocardiogram (ECG);
• The participant has evidence of significant, diffuse, or generalized lower motor neuron damage;
• The participant has received new concomitant medication less than 3 weeks before the study or has a dose of current concomitant medication that is expected to change during study;
• The participant has received botulinum toxin injection for spasticity within 4 months of the screening visit;
• The participant has taken any other investigational drugs within 30 days before screening;
• The participant is known to have been treated previously with dalfampridine (4 aminopyridine) in any formulation, whether through participation in a previous fampridine study or by self-medication.
• The participant has received locomotor training therapy within 6 months of the screening visit;
• The participant has a history of alcohol or drug abuse in the previous year;
• The participant has a medical condition that would interfere with interpretation of study results or study conduct.
• Note: Due to equipment and safety issues associated with locomotor training, participants must weigh less than 300 lbs.

Sponsors & Collaborators

• Kessler Foundation: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• Acorda Therapeutics: collaborator

Study Sites (1)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Steven C. Kirshblum, M.D.

  Kessler Institute for Rehabilitation

  PRINCIPAL INVESTIGATOR

• Gail F. Forrest, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

• Trevor A. Dyson-Hudson, M.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Cord Injury Research

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2012
• Primary Completion: October 9, 2017
• Study Completion: October 16, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

US (1)