Spinal Cord InjuryPhase 1/2NCT01484184

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

A Phase 1/2 study testing SPINALON (buspirone + levodopa + cardidopa) in people with Spinal Cord Injury, run by Nordic Life Science Pipeline Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Spinal Cord Injury
What is being tested?: SPINALON (buspirone + levodopa + cardidopa)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteCanada
Study dates: Jul 2013to Aug 2015
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

McGill University Health Centre (Montreal General Hospital)
Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

Official title: Tri-therapy (SPINALON)-Elicited Spinal Locomotor Network Activation: Phase I-IIa Clinical Trial in Patients With Chronic Spinal Cord Injury

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.

Read the detailed description

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: Spinal Cord Injury
Being tested: SPINALON (buspirone + levodopa + cardidopa)
Keywords: Completely paralyzed, Chronically injured, Central Pattern Generator, Locomotion, Secondary complications, Activity-based training, Treadmill training, Spinal cord injury, Paraplegia, Tetraplegia
Medical subject headings: Spinal Cord Injuries, Paraplegia, Quadriplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPINALON (buspirone + levodopa + cardidopa)Drug
Also called Apo-Buspirone 10 mg tablets (DIN 02211076), Sinemet 100/25 mg tablets (DIN 00513997)
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.

Study groups in NCT01484184
Study group	Role	What they receive
buspirone or levodopa/carbidopa	Active comparator	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. Receives: Drug: SPINALON (buspirone + levodopa + cardidopa)
Placebo	Placebo comparator	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. Receives: Drug: SPINALON (buspirone + levodopa + cardidopa)

What is being measured

The primary outcome is the main question the study is designed to answer.

Heart rate
Heart rate as a safety measure will be measured as beats per minute during 4 hours post-administration during the only administration
Measured: Steadily during 4 hours post-single administration vs pre-administration
Tolerability of common AEs
Frequent AEs such as nausea and hypotension will be specifically measured to assess tolerability and maximum tolerated dose. No more than 20% of subjects experiencing nausea with > grade 2 severity. Dose schedule without ≥ grade 3 hypotension. No potentiation of other AEs possibly found for each molecule administered separately
Measured: During 4 hours post-single administration vs pre-administration
Pharmacokinetics
Blood samples will be repeatedly obtained post-administration on the day of testing. HPLC analysis will be conducted to assess typical PK values (Cmax, Tmax, AUC) in order to determine whether or not the known PK profile of each active molecule (levodopa, carbidopa, buspirone) is changed once administered concomitantly (SPINALON)
Measured: 15, 30, 60, 120 and 240 min post-administration vs pre-administration
Blood pressure
Systolic and diastolic blood pressure values as a safety measure will be measured as mmHg during 4 hours
Measured: During 4 hours post-single administration vs pre-administration
Respiration rate
Respiration rate as number per minute will be measured as a safety issue during 4 hours post-administration compared with baseline value pre-administration on the day of testing
Measured: During 4 hours post-single administration vs pre-administration
Oxygen saturation
Oxygen saturation measured as CO2 level and O2 level in percentage will be measured on the day of testing during 4 hours post-administration compared with baseline level (pre-administration)
Measured: During 4 hours post-single administration vs. pre-administration
Temperature
Temperature measured in degrees Celsius will be measured during 4 hours post-administration on the day of testing compared with baseline value (pre-administration)
Measured: During 4 hours post-single administration vs. pre-administration
Change in hematology and biochemistry laboratory parameters
Blood samples at 4 hours post-administration will be analyzed for standard hematology (CBC) and biochemistry (liver and kidney markers) values and compared with baseline values (medical exam day sample).
Measured: Once at 4 hours post-single administration vs pre-administration

Secondary outcomes (1)

Occurrence of rhythmic leg EMGs
EMG activities of leg muscles will be measured with surface electrodes during 2 hours post-administration on the day of testing compared with baseline values pre-administration. Possible occurrence of involuntary rhythmic and bilateral movements assessed quantitatively will be sought.
Measured: During 2 hours post-administration vs pre-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Aug 2015

First posted2 Dec 2011 (estimated)
Study startJul 2013
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01484184
Sponsor's protocol ID: SPIN-01
Status last verified: Aug 2015
First submitted: 25 Nov 2011
Last updated: 20 Aug 2015
Results posted: No
Data monitoring committee: Yes

Publications

Guertin PA, Ung RV, Rouleau P, Steuer I. Effects on locomotion, muscle, bone, and blood induced by a combination therapy eliciting weight-bearing stepping in nonassisted spinal cord-transected mice. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):234-42. doi: 10.1177/1545968310378753. Epub 2010 Oct 15.
PubMed 20952632
Guertin PA, Ung RV, Rouleau P. Oral administration of a tri-therapy for central pattern generator activation in paraplegic mice: proof-of-concept of efficacy. Biotechnol J. 2010 Apr;5(4):421-6. doi: 10.1002/biot.200900278.
PubMed 20349462
Guertin PA. The mammalian central pattern generator for locomotion. Brain Res Rev. 2009 Dec 11;62(1):45-56. doi: 10.1016/j.brainresrev.2009.08.002. Epub 2009 Aug 29.
PubMed 19720083
Lapointe NP, Rouleau P, Ung RV, Guertin PA. Specific role of dopamine D1 receptors in spinal network activation and rhythmic movement induction in vertebrates. J Physiol. 2009 Apr 1;587(Pt 7):1499-511. doi: 10.1113/jphysiol.2008.166314. Epub 2009 Feb 9.
PubMed 19204052
Lapointe NP, Guertin PA. Synergistic effects of D1/5 and 5-HT1A/7 receptor agonists on locomotor movement induction in complete spinal cord-transected mice. J Neurophysiol. 2008 Jul;100(1):160-8. doi: 10.1152/jn.90339.2008. Epub 2008 May 14.
PubMed 18480366
Landry ES, Lapointe NP, Rouillard C, Levesque D, Hedlund PB, Guertin PA. Contribution of spinal 5-HT1A and 5-HT7 receptors to locomotor-like movement induced by 8-OH-DPAT in spinal cord-transected mice. Eur J Neurosci. 2006 Jul;24(2):535-46. doi: 10.1111/j.1460-9568.2006.04917.x. Epub 2006 Jul 12.
PubMed 16836640

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tri-therapy (SPINALON)-Elicited Spinal Locomotor Network Activation: Phase I-IIa Clinical Trial in Patients With Chronic Spinal Cord Injury
ClinicalTrials.gov ID: NCT01484184
Acronym / sponsor ID: SPIN-01
Conditions: Spinal Cord Injury
Keywords: Completely paralyzed, Chronically injured, Central Pattern Generator, Locomotion, Secondary complications, Activity-based training, Treadmill training, Spinal cord injury
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Nordic Life Science Pipeline Inc.University, hospital or other
Collaborators: United States Department of Defense
Study start: Jul 2013
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 2 Dec 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
buspirone or levodopa/carbidopa	Active comparator	Drug: SPINALON (buspirone + levodopa + cardidopa)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.
Placebo	Placebo comparator	Drug: SPINALON (buspirone + levodopa + cardidopa)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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (20 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPINALON (buspirone + levodopa + cardidopa)Also: Apo-Buspirone 10 mg tablets (DIN 02211076), Sinemet 100/25 mg tablets (DIN 00513997)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.	Drug	Placebo, buspirone or levodopa/carbidopa

Primary outcome

Heart rate
Time frame: Steadily during 4 hours post-single administration vs pre-administration
Heart rate as a safety measure will be measured as beats per minute during 4 hours post-administration during the only administration
Tolerability of common AEs
Time frame: During 4 hours post-single administration vs pre-administration
Frequent AEs such as nausea and hypotension will be specifically measured to assess tolerability and maximum tolerated dose. No more than 20% of subjects experiencing nausea with > grade 2 severity. Dose schedule without ≥ grade 3 hypotension. No potentiation of other AEs possibly found for each molecule administered separately
Pharmacokinetics
Time frame: 15, 30, 60, 120 and 240 min post-administration vs pre-administration
Blood samples will be repeatedly obtained post-administration on the day of testing. HPLC analysis will be conducted to assess typical PK values (Cmax, Tmax, AUC) in order to determine whether or not the known PK profile of each active molecule (levodopa, carbidopa, buspirone) is changed once administered concomitantly (SPINALON)
Blood pressure
Time frame: During 4 hours post-single administration vs pre-administration
Systolic and diastolic blood pressure values as a safety measure will be measured as mmHg during 4 hours
Respiration rate
Time frame: During 4 hours post-single administration vs pre-administration
Respiration rate as number per minute will be measured as a safety issue during 4 hours post-administration compared with baseline value pre-administration on the day of testing
Oxygen saturation
Time frame: During 4 hours post-single administration vs. pre-administration
Oxygen saturation measured as CO2 level and O2 level in percentage will be measured on the day of testing during 4 hours post-administration compared with baseline level (pre-administration)
Temperature
Time frame: During 4 hours post-single administration vs. pre-administration
Temperature measured in degrees Celsius will be measured during 4 hours post-administration on the day of testing compared with baseline value (pre-administration)
Change in hematology and biochemistry laboratory parameters
Time frame: Once at 4 hours post-single administration vs pre-administration
Blood samples at 4 hours post-administration will be analyzed for standard hematology (CBC) and biochemistry (liver and kidney markers) values and compared with baseline values (medical exam day sample).

1 secondary outcome

Occurrence of rhythmic leg EMGs
Time frame: During 2 hours post-administration vs pre-administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
Background: PubMed 20952632Guertin PA, Ung RV, Rouleau P, Steuer I. Effects on locomotion, muscle, bone, and blood induced by a combination therapy eliciting weight-bearing stepping in nonassisted spinal cord-transected mice. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):234-42. doi: 10.1177/1545968310378753. Epub 2010 Oct 15.
Background: PubMed 20349462Guertin PA, Ung RV, Rouleau P. Oral administration of a tri-therapy for central pattern generator activation in paraplegic mice: proof-of-concept of efficacy. Biotechnol J. 2010 Apr;5(4):421-6. doi: 10.1002/biot.200900278.
Background: PubMed 19720083Guertin PA. The mammalian central pattern generator for locomotion. Brain Res Rev. 2009 Dec 11;62(1):45-56. doi: 10.1016/j.brainresrev.2009.08.002. Epub 2009 Aug 29.
Background: PubMed 19204052Lapointe NP, Rouleau P, Ung RV, Guertin PA. Specific role of dopamine D1 receptors in spinal network activation and rhythmic movement induction in vertebrates. J Physiol. 2009 Apr 1;587(Pt 7):1499-511. doi: 10.1113/jphysiol.2008.166314. Epub 2009 Feb 9.
Background: PubMed 18480366Lapointe NP, Guertin PA. Synergistic effects of D1/5 and 5-HT1A/7 receptor agonists on locomotor movement induction in complete spinal cord-transected mice. J Neurophysiol. 2008 Jul;100(1):160-8. doi: 10.1152/jn.90339.2008. Epub 2008 May 14.
Background: PubMed 16836640Landry ES, Lapointe NP, Rouillard C, Levesque D, Hedlund PB, Guertin PA. Contribution of spinal 5-HT1A and 5-HT7 receptors to locomotor-like movement induced by 8-OH-DPAT in spinal cord-transected mice. Eur J Neurosci. 2006 Jul;24(2):535-46. doi: 10.1111/j.1460-9568.2006.04917.x. Epub 2006 Jul 12.
Sponsor's websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohan Radhakrishna, MD principal investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Pierre Guertin, Ph.D. study director

Nordic Life Science Pipeline/Université Laval

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SPINALON (buspirone + levodopa + cardidopa) in people with Spinal Cord Injury, run by Nordic Life Science Pipeline Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart rate (time frame: Steadily during 4 hours post-single administration vs pre-administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01484184, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.