Study to Assess Safety, Tolerability and MTD of a Central Pattern Generator-activating Tritherapy (SPINALON) in Patients With Chronic Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporarily induce episodes of involuntary locomotor movements. The primary objective of this Phase I/IIa study is to assess safety and tolerability of a single escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured patients. As a secondary objective, preliminary evidence of efficacy will also be sought.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

NCT00488839

Multiple Sclerosis

COMPLETED PHASE3

SISTERS: Spasticity In Stroke Study - Randomized Study

NCT01032239

Severe Spasticity

COMPLETED PHASE4

Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

NCT01683838

Spinal Cord Injury Muscle Spasticity

COMPLETED PHASE3

Trial in Adult Participants With Spinocerebellar Ataxia (SCA)

NCT02960893

Spinocerebellar Ataxias Spinocerebellar Ataxia Genotype Type 1 Spinocerebellar Ataxia Genotype Type 2 +5 more

COMPLETED PHASE2/PHASE3

Riluzole in Spinal Cord Injury Study

NCT01597518

Spinal Cord Injury

TERMINATED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Spinal cord injury (SCI) is generally considered as an irreversible condition for which no curative treatment has yet been found. A recent study sponsored by the Christopher \& Dana Reeve Foundation revealed an incidence ranging between 40 and 60 cases per million population and a prevalence estimated to be several times greater (new data: 1,275,000 cases) than previously reported(previous data: 200,000 cases).

SPINALON (levodopa + carbidopa + buspirone) was discovered by Dr. Guertin and colleagues as a drug treatment candidate that can acutely elicit temporarily (lasting approximately 30-60 minutes) episodes of CPG activity and corresponding powerful weight-bearing hindlimb stepping in completely SCI subjects (preclinical efficacy data obtained from mice and turtles completely spinal cord transected thoracically).

As such, SPINALON is currently being developed to become a chronic treatment (physical activity-based approach driven pharmacologically) against the multiple health problems or so-called 'secondary complications' associated specifically with the lack of physical activity (sarcopenia, osteoporosis, cardiovascular problems, dyslipidemia, obesity, type II diabetes, anemia, immune system deficiency, deep vein cloth, depression, etc.).

This study is a randomized, placebo-controlled, double-blind, single dose escalation study with fifty-one (51) patients who will receive either placebo capsules(starch) or capsules with buspirone only, levodopa/carbidopa only or buspirone/levodopa/carbidopa (SPINALON).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

buspirone or levodopa/carbidopa

Another 2-arm design will be tested composed of 16 subjects receiving drug A or drug B at MTD dose of the combined study drug as identified in the previous 2-arm groups.

Group Type ACTIVE_COMPARATOR

SPINALON (buspirone + levodopa + cardidopa)

Intervention Type DRUG

The proposed study is a combination of 1 and 2-arm designs. First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of the study drug, and the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively (not simultaneously) with increasing doses of SPINALON, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.This will be followed by a 2-arm composed of 1 group with 1 subject receiving placebo and 1 larger group (10 subjects) who will receive SPINALON at MTD as identified in the previous 2-arm groups.

Placebo

First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of SPINALON, the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively with increasing doses, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.

Group Type PLACEBO_COMPARATOR

SPINALON (buspirone + levodopa + cardidopa)

Intervention Type DRUG

The proposed study is a combination of 1 and 2-arm designs. First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of the study drug, and the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively (not simultaneously) with increasing doses of SPINALON, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.This will be followed by a 2-arm composed of 1 group with 1 subject receiving placebo and 1 larger group (10 subjects) who will receive SPINALON at MTD as identified in the previous 2-arm groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SPINALON (buspirone + levodopa + cardidopa)

The proposed study is a combination of 1 and 2-arm designs. First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of the study drug, and the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively (not simultaneously) with increasing doses of SPINALON, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.This will be followed by a 2-arm composed of 1 group with 1 subject receiving placebo and 1 larger group (10 subjects) who will receive SPINALON at MTD as identified in the previous 2-arm groups.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Apo-Buspirone 10 mg tablets (DIN 02211076) Sinemet 100/25 mg tablets (DIN 00513997)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of complete or motor-complete SCI (ASIA-A, ASIA-B)
* Chronically injured (at least 3 months post-injury)
* Paraplegic (within T1-T12) or tetraplegic (within C3-C8)
* In relatively good health condition (no significant bed sore, urinary tract infection)
* 18-65 years of age
* Men and women
* Quebec Province residents only

Exclusion Criteria

* With unclear diagnosis
* Displayed a form of involuntary rhythmic leg muscle activity (restless leg syndrome, spontaneous activity in supine position, etc.) in the last 3 months prior to this study.
* Acute or subacute stage (within 1 day and 3 months post-injury)
* Non-traumatic (e.g., multiple sclerosis, syringomyelia, spinal tumor,etc.)
* Are given monoamine oxidase (MAO) inhibitors (two weeks prior and after Spinalon administration)
* Had seizures
* Had tumor(s) (malignant or non-malignant) or in situ carcinoma in the last five (5) years
* Allergic or hypersensitive to buspirone, levodopa or carbidopa
* Can not take sympathomimetic amines (e.g., epinephrine, pseudoephedrine)
* Currently suffering of heart problems, blood related diseases, endocrine disease, liver disease, lung disease, or kidney disease
* Receiving antihypertensive drugs
* Receiving tricyclic antidepressant
* Receiving dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone)
* Receiving phenytoin and papaverine
* With glaucoma
* With psychiatric or mental disorder(s)
* Had gastrointestinal ulcer(s) in the last five (5) years
* Pregnant or lactating woman (all women between 18 and 50 year-old not yet confirmed as pregnant, will be tested (urine test - TestPak Plus, Abbott Laboratories) on medical exam-day due to the teratogenic potential of levodopa/carbidopa.
* Children (younger than 18 year-old) or elderly (older than 65 year-old)
* Not resident of Quebec Province

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No